Trial List
List all clinical trials by discovery date. Accepts regular expressions in search.
GET /trials/?format=api&page=69
{ "count": 4829, "next": "http://api.gregory-ms.com/trials/?format=api&page=70", "previous": "http://api.gregory-ms.com/trials/?format=api&page=68", "results": [ { "trial_id": 3666, "title": "Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple Sclerosis Who Participated in the MS-F204 Trial", "summary": null, "published_date": "2008-03-28T00:00:00Z", "discovery_date": "2023-12-06T18:18:22.474393Z", "link": "https://clinicaltrials.gov/show/NCT00649792", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT00649792" }, "categories": [], "export_date": "2024-04-19T00:00:00Z", "internal_number": "6489566", "last_refreshed_on": "2017-10-19", "scientific_title": "Phase 3 Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple Sclerosis Who Participated in the MS-F204 Trial", "primary_sponsor": "Acorda Therapeutics", "retrospective_flag": "No", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Not recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "70 Years", "inclusion_gender": "All", "date_enrollement": "2007-08-19", "target_size": "214", "study_type": "Interventional", "study_design": null, "phase": "Phase 3", "countries": "United States;Canada;United States;United States;Canada;United States;United States;Canada;United States;United States;Canada;United States", "contact_firstname": "; ; ;", "contact_lastname": "Bonnie Faust;Bonnie Faust;Bonnie Faust;Bonnie Faust", "contact_address": null, "contact_email": ";;;", "contact_tel": ";;;", "contact_affiliation": "Acorda Therapeutics;Acorda Therapeutics;Acorda Therapeutics;Acorda Therapeutics", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - Patient must have been previously enrolled in the Acorda Therapeutics MS-F204 study\r<br> and received either Fampridine-SR or placebo\r<br>\r<br> - Patient with clinically defined multiple sclerosis (the diagnostic criteria based on:\r<br> McDonald WI, et al. Recommended Diagnostic Criteria for Multiple Sclerosis: Guidelines\r<br> from the International Panel on the Diagnosis of Multiple Sclerosis. Annals of\r<br> Neurology. 2001; 50: 121-127)\r<br>\r<br> - Patient must be at least 18 years of age. Any patient who is now over the age of 70\r<br> must be in good overall health in the judgment of the investigator\r<br>\r<br> - Patient must be of adequate cognitive function, as judged by the Investigator\r<br>\r<br> - Patients who are women of childbearing potential must have a negative urine pregnancy\r<br> test at the screening visit\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Female patients who are either pregnant or breastfeeding.\r<br>\r<br> - Women of childbearing potential who are not using a specified birth control method\r<br>\r<br> - Patients discontinued prematurely from the MS-F204 study\r<br>\r<br> - Patients with a history of seizures or with evidence of past, or possible epileptiform\r<br> activity on an EEG\r<br>\r<br> - Patient with either a clinically significant abnormal ECG or laboratory values at the\r<br> MS-F204 EXT screening visit\r<br>\r<br> - Patient with severe renal impairment\r<br>\r<br> - Patient with angina, uncontrolled hypertension, clinically significant cardiac\r<br> arrhythmias, or any other clinically significant cardiovascular abnormality, as judged\r<br> by the Investigator\r<br>\r<br> - Patient with a known allergy to pyridine-containing substances or any of the inactive\r<br> ingredients of the Fampridine-SR tablet\r<br>\r<br> - Patient who has received an investigational drug (other than Fampridine-SR or placebo\r<br> under MS-F204 study) within 30 days of the MS-F204EXT screening visit or a patient who\r<br> is scheduled to enroll in an investigational drug trial at any time during this study\r<br>\r<br> - Patient who has a history of drug or alcohol abuse within the past year\r<br> ;\r<br> Inclusion Criteria:\r<br>\r<br> - Patient must have been previously enrolled in the Acorda Therapeutics MS-F204 study\r<br> and received either Fampridine-SR or placebo\r<br>\r<br> - Patient with clinically defined multiple sclerosis (the diagnostic criteria based on:\r<br> McDonald WI, et al. Recommended Diagnostic Criteria for Multiple Sclerosis: Guidelines\r<br> from the International Panel on the Diagnosis of Multiple Sclerosis. Annals of\r<br> Neurology. 2001; 50: 121-127)\r<br>\r<br> - Patient must be at least 18 years of age. Any patient who is now over the age of 70\r<br> must be in good overall health in the judgment of the investigator\r<br>\r<br> - Patient must be of adequate cognitive function, as judged by the Investigator\r<br>\r<br> - Patients who are women of childbearing potential must have a negative urine pregnancy\r<br> test at the screening visit\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Female patients who are either pregnant or breastfeeding.\r<br>\r<br> - Women of childbearing potential who are not using a specified birth control method\r<br>\r<br> - Patients discontinued prematurely from the MS-F204 study\r<br>\r<br> - Patients with a history of seizures or with evidence of past, or possible epileptiform\r<br> activity on an EEG\r<br>\r<br> - Patient with either a clinically significant abnormal ECG or laboratory values at the\r<br> MS-F204 EXT screening visit\r<br>\r<br> - Patient with severe renal impairment\r<br>\r<br> - Patient with angina, uncontrolled hypertension, clinically significant cardiac\r<br> arrhythmias, or any other clinically significant cardiovascular abnormality, as judged\r<br> by the Investigator\r<br>\r<br> - Patient with a known allergy to pyridine-containing substances or any of the inactive\r<br> ingredients of the Fampridine-SR tablet\r<br>\r<br> - Patient who has received an investigational drug (other than Fampridine-SR or placebo\r<br> under MS-F204 study) within 30 days of the MS-F204EXT screening visit or a patient who\r<br> is scheduled to enroll in an investigational drug trial at any time during this study\r<br>\r<br> - Patient who has a history of drug or alcohol abuse within the past year\r<br> ;\r<br> Inclusion Criteria:\r<br>\r<br> - Patient must have been previously enrolled in the Acorda Therapeutics MS-F204 study\r<br> and received either Fampridine-SR or placebo\r<br>\r<br> - Patient with clinically defined multiple sclerosis (the diagnostic criteria based on:\r<br> McDonald WI, et al. Recommended Diagnostic Criteria for Multiple Sclerosis: Guidelines\r<br> from the International Panel on the Diagnosis of Multiple Sclerosis. Annals of\r<br> Neurology. 2001; 50: 121-127)\r<br>\r<br> - Patient must be at least 18 years of age. Any patient who is now over the age of 70\r<br> must be in good overall health in the judgment of the investigator\r<br>\r<br> - Patient must be of adequate cognitive function, as judged by the Investigator\r<br>\r<br> - Patients who are women of childbearing potential must have a negative urine pregnancy\r<br> test at the screening visit\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Female patients who are either pregnant or breastfeeding.\r<br>\r<br> - Women of childbearing potential who are not using a specified birth control method\r<br>\r<br> - Patients discontinued prematurely from the MS-F204 study\r<br>\r<br> - Patients with a history of seizures or with evidence of past, or possible epileptiform\r<br> activity on an EEG\r<br>\r<br> - Patient with either a clinically significant abnormal ECG or laboratory values at the\r<br> MS-F204 EXT screening visit\r<br>\r<br> - Patient with severe renal impairment\r<br>\r<br> - Patient with angina, uncontrolled hypertension, clinically significant cardiac\r<br> arrhythmias, or any other clinically significant cardiovascular abnormality, as judged\r<br> by the Investigator\r<br>\r<br> - Patient with a known allergy to pyridine-containing substances or any of the inactive\r<br> ingredients of the Fampridine-SR tablet\r<br>\r<br> - Patient who has received an investigational drug (other than Fampridine-SR or placebo\r<br> under MS-F204 study) within 30 days of the MS-F204EXT screening visit or a patient who\r<br> is scheduled to enroll in an investigational drug trial at any time during this study\r<br>\r<br> - Patient who has a history of drug or alcohol abuse within the past year\r<br> ;\r<br> Inclusion Criteria:\r<br>\r<br> - Patient must have been previously enrolled in the Acorda Therapeutics MS-F204 study\r<br> and received either Fampridine-SR or placebo\r<br>\r<br> - Patient with clinically defined multiple sclerosis (the diagnostic criteria based on:\r<br> McDonald WI, et al. Recommended Diagnostic Criteria for Multiple Sclerosis: Guidelines\r<br> from the International Panel on the Diagnosis of Multiple Sclerosis. Annals of\r<br> Neurology. 2001; 50: 121-127)\r<br>\r<br> - Patient must be at least 18 years of age. Any patient who is now over the age of 70\r<br> must be in good overall health in the judgment of the investigator\r<br>\r<br> - Patient must be of adequate cognitive function, as judged by the Investigator\r<br>\r<br> - Patients who are women of childbearing potential must have a negative urine pregnancy\r<br> test at the screening visit\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Female patients who are either pregnant or breastfeeding.\r<br>\r<br> - Women of childbearing potential who are not using a specified birth control method\r<br>\r<br> - Patients discontinued prematurely from the MS-F204 study\r<br>\r<br> - Patients with a history of seizures or with evidence of past, or possible epileptiform\r<br> activity on an EEG\r<br>\r<br> - Patient with either a clinically significant abnormal ECG or laboratory values at the\r<br> MS-F204 EXT screening visit\r<br>\r<br> - Patient with severe renal impairment\r<br>\r<br> - Patient with angina, uncontrolled hypertension, clinically significant cardiac\r<br> arrhythmias, or any other clinically significant cardiovascular abnormality, as judged\r<br> by the Investigator\r<br>\r<br> - Patient with a known allergy to pyridine-containing substances or any of the inactive\r<br> ingredients of the Fampridine-SR tablet\r<br>\r<br> - Patient who has received an investigational drug (other than Fampridine-SR or placebo\r<br> under MS-F204 study) within 30 days of the MS-F204EXT screening visit or a patient who\r<br> is scheduled to enroll in an investigational drug trial at any time during this study\r<br>\r<br> - Patient who has a history of drug or alcohol abuse within the past year\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis;Multiple Sclerosis;Multiple Sclerosis;Multiple Sclerosis", "intervention": "Drug: Fampridine-SR;Drug: Fampridine-SR;Drug: Fampridine-SR;Drug: Fampridine-SR", "primary_outcome": "Summary of Treatment Emergent Adverse Events (TEAE).;Summary of Treatment Emergent Adverse Events (TEAE).", "secondary_outcome": "Timed 25-Foot Walk (T25FW);Subject Global Impression (SGI);Clinician's Global Impression (CGI);Expanded Disability Status Scale (EDSS)", "secondary_id": "MS-F204 EXT", "source_support": "Please refer to primary and secondary sponsors", "ethics_review_status": null, "ethics_review_approval_date": null, "ethics_review_contact_name": null, "ethics_review_contact_address": null, "ethics_review_contact_phone": null, "ethics_review_contact_email": null, "results_date_completed": null, "results_url_link": null }, { "trial_id": 3665, "title": "Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR Tablets in Multiple Sclerosis Patients Who Participated in the MS-F203 Trial", "summary": null, "published_date": "2008-03-28T00:00:00Z", "discovery_date": "2023-12-06T18:18:22.450912Z", "link": "https://clinicaltrials.gov/show/NCT00648908", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT00648908" }, "categories": [], "export_date": "2024-04-19T00:00:00Z", "internal_number": "6489562", "last_refreshed_on": "2017-10-19", "scientific_title": "Phase 3 Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Subjects With Multiple Sclerosis Who Participated in the MS-F203 Trial", "primary_sponsor": "Acorda Therapeutics", "retrospective_flag": "No", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Not recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "70 Years", "inclusion_gender": "All", "date_enrollement": "2006-06-19", "target_size": "269", "study_type": "Interventional", "study_design": null, "phase": "Phase 3", "countries": "United States;Canada;United States;United States;Canada;United States;United States;Canada;United States;United States;Canada;United States", "contact_firstname": "; ; ;", "contact_lastname": "Bonnie Faust;Bonnie Faust;Bonnie Faust;Bonnie Faust", "contact_address": null, "contact_email": ";;;", "contact_tel": ";;;", "contact_affiliation": "Acorda Therapeutics;Acorda Therapeutics;Acorda Therapeutics;Acorda Therapeutics", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - subject must have been previously enrolled in Acorda Therapeutics MS-F203 study for\r<br> multiple sclerosis and received either Fampridine-SR or placebo\r<br>\r<br> - subject is a man or woman with clinical definite multiple sclerosis as defined by\r<br> McDonald (McDonald WI, et al. Recommended Diagnostic Criteria for Multiple Sclerosis;\r<br> Guidelines from the International Panel on the Diagnosis of Multiple Sclerosis; Annals\r<br> of Neurology. 2001; 50: 121-127)\r<br>\r<br> - subject must be at least 18 years of age. Any subject who is now over the age of 70\r<br> must be in good overall health in the judgment of the Investigator\r<br>\r<br> - subject must be of adequate cognitive function, as judged by the Investigator, to\r<br> understand and sign the IRB/REB-approved informed consent form prior to the\r<br> performance of any study-specific procedures and is willing to comply with the\r<br> required scheduling and assessments of the protocol\r<br>\r<br> - subjects who are women of childbearing potential, regardless of sexual activity, must\r<br> have a negative urine pregnancy test at the Screening Visit.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - women who are either pregnant or breastfeeding, and women of childbearing potential\r<br> (defined as not surgically sterile or at least two years post menopausal) who are\r<br> engaged in active heterosexual relations and, are not using one of the following birth\r<br> control methods: tubal ligation, implantable contraception device, oral, patch,\r<br> injectable or transdermal contraceptive, barrier method or sexual activity restricted\r<br> to vasectomized partner.\r<br>\r<br> - subject discontinued prematurely from the MS-F203 study\r<br>\r<br> - subject has a history of seizures or has evidence of past, or possible, epileptiform\r<br> activity on an EEG\r<br>\r<br> - subject has either a clinically significant abnormal ECG or laboratory value(s) at the\r<br> Screening visit, as judged by the Investigator that would preclude entry into the\r<br> study. ECG and laboratory results from Visit 6 or repeat results from Visit 7 of the\r<br> MS-F203 study may be used as the baseline for the current study\r<br>\r<br> - subject has angina, uncontrolled hypertension, clinically significant cardiac\r<br> arrhythmias, or any other clinically significant cardiovascular abnormality, as judged\r<br> by the Investigator\r<br>\r<br> - subject has a known allergy to pyridine-containing substances or any of the inactive\r<br> ingredients of the Fampridine-SR tablet (hydroxypropyl methylcellulose,\r<br> microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate, opadry\r<br> white (tablet film coating))\r<br>\r<br> - subject has received an investigational drug, except for Fampridine-SR or matching\r<br> placebo under protocol MS-F203, within 30 days of the Screening Visit. Subject is\r<br> scheduled to enroll in an investigational drug trial at any time during this study.\r<br>\r<br> - subject has a history of drug or alcohol abuse within the past year\r<br> ;\r<br> Inclusion Criteria:\r<br>\r<br> - subject must have been previously enrolled in Acorda Therapeutics MS-F203 study for\r<br> multiple sclerosis and received either Fampridine-SR or placebo\r<br>\r<br> - subject is a man or woman with clinical definite multiple sclerosis as defined by\r<br> McDonald (McDonald WI, et al. Recommended Diagnostic Criteria for Multiple Sclerosis;\r<br> Guidelines from the International Panel on the Diagnosis of Multiple Sclerosis; Annals\r<br> of Neurology. 2001; 50: 121-127)\r<br>\r<br> - subject must be at least 18 years of age. Any subject who is now over the age of 70\r<br> must be in good overall health in the judgment of the Investigator\r<br>\r<br> - subject must be of adequate cognitive function, as judged by the Investigator, to\r<br> understand and sign the IRB/REB-approved informed consent form prior to the\r<br> performance of any study-specific procedures and is willing to comply with the\r<br> required scheduling and assessments of the protocol\r<br>\r<br> - subjects who are women of childbearing potential, regardless of sexual activity, must\r<br> have a negative urine pregnancy test at the Screening Visit.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - women who are either pregnant or breastfeeding, and women of childbearing potential\r<br> (defined as not surgically sterile or at least two years post menopausal) who are\r<br> engaged in active heterosexual relations and, are not using one of the following birth\r<br> control methods: tubal ligation, implantable contraception device, oral, patch,\r<br> injectable or transdermal contraceptive, barrier method or sexual activity restricted\r<br> to vasectomized partner.\r<br>\r<br> - subject discontinued prematurely from the MS-F203 study\r<br>\r<br> - subject has a history of seizures or has evidence of past, or possible, epileptiform\r<br> activity on an EEG\r<br>\r<br> - subject has either a clinically significant abnormal ECG or laboratory value(s) at the\r<br> Screening visit, as judged by the Investigator that would preclude entry into the\r<br> study. ECG and laboratory results from Visit 6 or repeat results from Visit 7 of the\r<br> MS-F203 study may be used as the baseline for the current study\r<br>\r<br> - subject has angina, uncontrolled hypertension, clinically significant cardiac\r<br> arrhythmias, or any other clinically significant cardiovascular abnormality, as judged\r<br> by the Investigator\r<br>\r<br> - subject has a known allergy to pyridine-containing substances or any of the inactive\r<br> ingredients of the Fampridine-SR tablet (hydroxypropyl methylcellulose,\r<br> microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate, opadry\r<br> white (tablet film coating))\r<br>\r<br> - subject has received an investigational drug, except for Fampridine-SR or matching\r<br> placebo under protocol MS-F203, within 30 days of the Screening Visit. Subject is\r<br> scheduled to enroll in an investigational drug trial at any time during this study.\r<br>\r<br> - subject has a history of drug or alcohol abuse within the past year\r<br> ;\r<br> Inclusion Criteria:\r<br>\r<br> - subject must have been previously enrolled in Acorda Therapeutics MS-F203 study for\r<br> multiple sclerosis and received either Fampridine-SR or placebo\r<br>\r<br> - subject is a man or woman with clinical definite multiple sclerosis as defined by\r<br> McDonald (McDonald WI, et al. Recommended Diagnostic Criteria for Multiple Sclerosis;\r<br> Guidelines from the International Panel on the Diagnosis of Multiple Sclerosis; Annals\r<br> of Neurology. 2001; 50: 121-127)\r<br>\r<br> - subject must be at least 18 years of age. Any subject who is now over the age of 70\r<br> must be in good overall health in the judgment of the Investigator\r<br>\r<br> - subject must be of adequate cognitive function, as judged by the Investigator, to\r<br> understand and sign the IRB/REB-approved informed consent form prior to the\r<br> performance of any study-specific procedures and is willing to comply with the\r<br> required scheduling and assessments of the protocol\r<br>\r<br> - subjects who are women of childbearing potential, regardless of sexual activity, must\r<br> have a negative urine pregnancy test at the Screening Visit.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - women who are either pregnant or breastfeeding, and women of childbearing potential\r<br> (defined as not surgically sterile or at least two years post menopausal) who are\r<br> engaged in active heterosexual relations and, are not using one of the following birth\r<br> control methods: tubal ligation, implantable contraception device, oral, patch,\r<br> injectable or transdermal contraceptive, barrier method or sexual activity restricted\r<br> to vasectomized partner.\r<br>\r<br> - subject discontinued prematurely from the MS-F203 study\r<br>\r<br> - subject has a history of seizures or has evidence of past, or possible, epileptiform\r<br> activity on an EEG\r<br>\r<br> - subject has either a clinically significant abnormal ECG or laboratory value(s) at the\r<br> Screening visit, as judged by the Investigator that would preclude entry into the\r<br> study. ECG and laboratory results from Visit 6 or repeat results from Visit 7 of the\r<br> MS-F203 study may be used as the baseline for the current study\r<br>\r<br> - subject has angina, uncontrolled hypertension, clinically significant cardiac\r<br> arrhythmias, or any other clinically significant cardiovascular abnormality, as judged\r<br> by the Investigator\r<br>\r<br> - subject has a known allergy to pyridine-containing substances or any of the inactive\r<br> ingredients of the Fampridine-SR tablet (hydroxypropyl methylcellulose,\r<br> microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate, opadry\r<br> white (tablet film coating))\r<br>\r<br> - subject has received an investigational drug, except for Fampridine-SR or matching\r<br> placebo under protocol MS-F203, within 30 days of the Screening Visit. Subject is\r<br> scheduled to enroll in an investigational drug trial at any time during this study.\r<br>\r<br> - subject has a history of drug or alcohol abuse within the past year\r<br> ;\r<br> Inclusion Criteria:\r<br>\r<br> - subject must have been previously enrolled in Acorda Therapeutics MS-F203 study for\r<br> multiple sclerosis and received either Fampridine-SR or placebo\r<br>\r<br> - subject is a man or woman with clinical definite multiple sclerosis as defined by\r<br> McDonald (McDonald WI, et al. Recommended Diagnostic Criteria for Multiple Sclerosis;\r<br> Guidelines from the International Panel on the Diagnosis of Multiple Sclerosis; Annals\r<br> of Neurology. 2001; 50: 121-127)\r<br>\r<br> - subject must be at least 18 years of age. Any subject who is now over the age of 70\r<br> must be in good overall health in the judgment of the Investigator\r<br>\r<br> - subject must be of adequate cognitive function, as judged by the Investigator, to\r<br> understand and sign the IRB/REB-approved informed consent form prior to the\r<br> performance of any study-specific procedures and is willing to comply with the\r<br> required scheduling and assessments of the protocol\r<br>\r<br> - subjects who are women of childbearing potential, regardless of sexual activity, must\r<br> have a negative urine pregnancy test at the Screening Visit.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - women who are either pregnant or breastfeeding, and women of childbearing potential\r<br> (defined as not surgically sterile or at least two years post menopausal) who are\r<br> engaged in active heterosexual relations and, are not using one of the following birth\r<br> control methods: tubal ligation, implantable contraception device, oral, patch,\r<br> injectable or transdermal contraceptive, barrier method or sexual activity restricted\r<br> to vasectomized partner.\r<br>\r<br> - subject discontinued prematurely from the MS-F203 study\r<br>\r<br> - subject has a history of seizures or has evidence of past, or possible, epileptiform\r<br> activity on an EEG\r<br>\r<br> - subject has either a clinically significant abnormal ECG or laboratory value(s) at the\r<br> Screening visit, as judged by the Investigator that would preclude entry into the\r<br> study. ECG and laboratory results from Visit 6 or repeat results from Visit 7 of the\r<br> MS-F203 study may be used as the baseline for the current study\r<br>\r<br> - subject has angina, uncontrolled hypertension, clinically significant cardiac\r<br> arrhythmias, or any other clinically significant cardiovascular abnormality, as judged\r<br> by the Investigator\r<br>\r<br> - subject has a known allergy to pyridine-containing substances or any of the inactive\r<br> ingredients of the Fampridine-SR tablet (hydroxypropyl methylcellulose,\r<br> microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate, opadry\r<br> white (tablet film coating))\r<br>\r<br> - subject has received an investigational drug, except for Fampridine-SR or matching\r<br> placebo under protocol MS-F203, within 30 days of the Screening Visit. Subject is\r<br> scheduled to enroll in an investigational drug trial at any time during this study.\r<br>\r<br> - subject has a history of drug or alcohol abuse within the past year\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis;Multiple Sclerosis;Multiple Sclerosis;Multiple Sclerosis", "intervention": "Drug: Fampridine-SR;Drug: Fampridine-SR;Drug: Fampridine-SR;Drug: Fampridine-SR", "primary_outcome": "Summary of Treatment Emergent Adverse Events (TEAE).;Summary of Treatment Emergent Adverse Events (TEAE).", "secondary_outcome": "Timed 25 Foot Walk (T25FW);Subject Global Impression (SGI);Clinician Global Impression of Change (CGIC);Expanded Disability Status Scale (EDSS)", "secondary_id": "MS-F203EXT", "source_support": "Please refer to primary and secondary sponsors", "ethics_review_status": null, "ethics_review_approval_date": null, "ethics_review_contact_name": null, "ethics_review_contact_address": null, "ethics_review_contact_phone": null, "ethics_review_contact_email": null, "results_date_completed": null, "results_url_link": null }, { "trial_id": 3664, "title": "Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple Sclerosis", "summary": null, "published_date": "2008-04-04T00:00:00Z", "discovery_date": "2023-12-06T18:18:22.428517Z", "link": "https://clinicaltrials.gov/show/NCT00654927", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT00654927" }, "categories": [], "export_date": "2024-04-19T00:00:00Z", "internal_number": "6489629", "last_refreshed_on": "2017-10-19", "scientific_title": "Phase 3 Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple Sclerosis", "primary_sponsor": "Acorda Therapeutics", "retrospective_flag": "No", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Not recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "70 Years", "inclusion_gender": "All", "date_enrollement": "2003-11-19", "target_size": "177", "study_type": "Interventional", "study_design": null, "phase": "Phase 3", "countries": "United States;Canada;United States;United States;Canada;United States;United States;Canada;United States;United States;Canada;United States", "contact_firstname": "; ; ;", "contact_lastname": "Bonnie Faust;Bonnie Faust;Bonnie Faust;Bonnie Faust", "contact_address": null, "contact_email": ";;;", "contact_tel": ";;;", "contact_affiliation": "Acorda Therapeutics;Acorda Therapeutics;Acorda Therapeutics;Acorda Therapeutics", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - The subject must have been previously enrolled in an Acorda Therapeutics or an Elan\r<br> Corporation sponsored study for multiple sclerosis and received either Fampridine or\r<br> placebo.\r<br>\r<br> - The subject must have multiple sclerosis as determined by the Principal Investigator.\r<br>\r<br> - The subject, male or female, must be at least 18 years of age. Any subject who is now\r<br> over the age of 70 must be in good overall health in the judgment of the Investigator.\r<br>\r<br> - The subject must be of adequate cognitive function, as judged by the Investigator.\r<br>\r<br> - Any subject who is female and of childbearing potential, regardless of sexual\r<br> activity, must have a negative urine pregnancy test at the Screening Visit.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - The subject is a female who is either pregnant or breastfeeding, or of child-bearing\r<br> potential, who, if engaged in active heterosexual relations and has not had a\r<br> hysterectomy or bilateral oophorectomy, would not use one of the following birth\r<br> control methods: tubal ligation, implantable contraception device, oral, injectable or\r<br> transdermal contraceptive, barrier method or sexual activity restricted to\r<br> vasectomized partner.\r<br>\r<br> - The subject withdrew from a previous Fampridine study because of a Serious Adverse\r<br> Event that was possibly, probably or definitely related to Fampridine.\r<br>\r<br> - The subject has a history of seizures or has evidence of past, or possible,\r<br> epileptiform activity on an EEG.\r<br>\r<br> - The subject has either a clinically significant abnormal ECG or laboratory value(s) at\r<br> the Screening Visit, as judged by the Investigator\r<br>\r<br> - The subject has angina, uncontrolled hypertension, clinically significant cardiac\r<br> arrhythmias, or any other clinically significant cardiovascular abnormality, as judged\r<br> by the Investigator.\r<br>\r<br> - The subject has a known allergy to pyridine-containing substances or any of the\r<br> inactive ingredients of the Fampridine tablet\r<br>\r<br> - The subject has received an investigational drug, except for Fampridine- SR (or\r<br> matching placebo) under Protocol MS-F202, within 30 days prior to the Screening Visit;\r<br> or the subject is scheduled to enroll in an investigational drug trial at any time\r<br> during this study.\r<br>\r<br> - The subject has received compounded 4-aminopyridine (4-AP) within 14 days of the\r<br> Screening Visit.\r<br>\r<br> - The subject has had an onset of an MS exacerbation within 30 days prior to the\r<br> Screening Visit, or, if in the judgment of the Investigator, has not stabilized from a\r<br> prior exacerbation episode.\r<br>\r<br> - The subject has started on a concomitant medication regimen for an underlying\r<br> disease/symptom within the past 7 days; or has started an interferon or\r<br> chemotherapeutic agent for multiple sclerosis within the past 4 weeks.\r<br>\r<br> - The subject has a history of drug or alcohol abuse within the past year.\r<br> ;\r<br> Inclusion Criteria:\r<br>\r<br> - The subject must have been previously enrolled in an Acorda Therapeutics or an Elan\r<br> Corporation sponsored study for multiple sclerosis and received either Fampridine or\r<br> placebo.\r<br>\r<br> - The subject must have multiple sclerosis as determined by the Principal Investigator.\r<br>\r<br> - The subject, male or female, must be at least 18 years of age. Any subject who is now\r<br> over the age of 70 must be in good overall health in the judgment of the Investigator.\r<br>\r<br> - The subject must be of adequate cognitive function, as judged by the Investigator.\r<br>\r<br> - Any subject who is female and of childbearing potential, regardless of sexual\r<br> activity, must have a negative urine pregnancy test at the Screening Visit.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - The subject is a female who is either pregnant or breastfeeding, or of child-bearing\r<br> potential, who, if engaged in active heterosexual relations and has not had a\r<br> hysterectomy or bilateral oophorectomy, would not use one of the following birth\r<br> control methods: tubal ligation, implantable contraception device, oral, injectable or\r<br> transdermal contraceptive, barrier method or sexual activity restricted to\r<br> vasectomized partner.\r<br>\r<br> - The subject withdrew from a previous Fampridine study because of a Serious Adverse\r<br> Event that was possibly, probably or definitely related to Fampridine.\r<br>\r<br> - The subject has a history of seizures or has evidence of past, or possible,\r<br> epileptiform activity on an EEG.\r<br>\r<br> - The subject has either a clinically significant abnormal ECG or laboratory value(s) at\r<br> the Screening Visit, as judged by the Investigator\r<br>\r<br> - The subject has angina, uncontrolled hypertension, clinically significant cardiac\r<br> arrhythmias, or any other clinically significant cardiovascular abnormality, as judged\r<br> by the Investigator.\r<br>\r<br> - The subject has a known allergy to pyridine-containing substances or any of the\r<br> inactive ingredients of the Fampridine tablet\r<br>\r<br> - The subject has received an investigational drug, except for Fampridine- SR (or\r<br> matching placebo) under Protocol MS-F202, within 30 days prior to the Screening Visit;\r<br> or the subject is scheduled to enroll in an investigational drug trial at any time\r<br> during this study.\r<br>\r<br> - The subject has received compounded 4-aminopyridine (4-AP) within 14 days of the\r<br> Screening Visit.\r<br>\r<br> - The subject has had an onset of an MS exacerbation within 30 days prior to the\r<br> Screening Visit, or, if in the judgment of the Investigator, has not stabilized from a\r<br> prior exacerbation episode.\r<br>\r<br> - The subject has started on a concomitant medication regimen for an underlying\r<br> disease/symptom within the past 7 days; or has started an interferon or\r<br> chemotherapeutic agent for multiple sclerosis within the past 4 weeks.\r<br>\r<br> - The subject has a history of drug or alcohol abuse within the past year.\r<br> ;\r<br> Inclusion Criteria:\r<br>\r<br> - The subject must have been previously enrolled in an Acorda Therapeutics or an Elan\r<br> Corporation sponsored study for multiple sclerosis and received either Fampridine or\r<br> placebo.\r<br>\r<br> - The subject must have multiple sclerosis as determined by the Principal Investigator.\r<br>\r<br> - The subject, male or female, must be at least 18 years of age. Any subject who is now\r<br> over the age of 70 must be in good overall health in the judgment of the Investigator.\r<br>\r<br> - The subject must be of adequate cognitive function, as judged by the Investigator.\r<br>\r<br> - Any subject who is female and of childbearing potential, regardless of sexual\r<br> activity, must have a negative urine pregnancy test at the Screening Visit.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - The subject is a female who is either pregnant or breastfeeding, or of child-bearing\r<br> potential, who, if engaged in active heterosexual relations and has not had a\r<br> hysterectomy or bilateral oophorectomy, would not use one of the following birth\r<br> control methods: tubal ligation, implantable contraception device, oral, injectable or\r<br> transdermal contraceptive, barrier method or sexual activity restricted to\r<br> vasectomized partner.\r<br>\r<br> - The subject withdrew from a previous Fampridine study because of a Serious Adverse\r<br> Event that was possibly, probably or definitely related to Fampridine.\r<br>\r<br> - The subject has a history of seizures or has evidence of past, or possible,\r<br> epileptiform activity on an EEG.\r<br>\r<br> - The subject has either a clinically significant abnormal ECG or laboratory value(s) at\r<br> the Screening Visit, as judged by the Investigator\r<br>\r<br> - The subject has angina, uncontrolled hypertension, clinically significant cardiac\r<br> arrhythmias, or any other clinically significant cardiovascular abnormality, as judged\r<br> by the Investigator.\r<br>\r<br> - The subject has a known allergy to pyridine-containing substances or any of the\r<br> inactive ingredients of the Fampridine tablet\r<br>\r<br> - The subject has received an investigational drug, except for Fampridine- SR (or\r<br> matching placebo) under Protocol MS-F202, within 30 days prior to the Screening Visit;\r<br> or the subject is scheduled to enroll in an investigational drug trial at any time\r<br> during this study.\r<br>\r<br> - The subject has received compounded 4-aminopyridine (4-AP) within 14 days of the\r<br> Screening Visit.\r<br>\r<br> - The subject has had an onset of an MS exacerbation within 30 days prior to the\r<br> Screening Visit, or, if in the judgment of the Investigator, has not stabilized from a\r<br> prior exacerbation episode.\r<br>\r<br> - The subject has started on a concomitant medication regimen for an underlying\r<br> disease/symptom within the past 7 days; or has started an interferon or\r<br> chemotherapeutic agent for multiple sclerosis within the past 4 weeks.\r<br>\r<br> - The subject has a history of drug or alcohol abuse within the past year.\r<br> ;\r<br> Inclusion Criteria:\r<br>\r<br> - The subject must have been previously enrolled in an Acorda Therapeutics or an Elan\r<br> Corporation sponsored study for multiple sclerosis and received either Fampridine or\r<br> placebo.\r<br>\r<br> - The subject must have multiple sclerosis as determined by the Principal Investigator.\r<br>\r<br> - The subject, male or female, must be at least 18 years of age. Any subject who is now\r<br> over the age of 70 must be in good overall health in the judgment of the Investigator.\r<br>\r<br> - The subject must be of adequate cognitive function, as judged by the Investigator.\r<br>\r<br> - Any subject who is female and of childbearing potential, regardless of sexual\r<br> activity, must have a negative urine pregnancy test at the Screening Visit.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - The subject is a female who is either pregnant or breastfeeding, or of child-bearing\r<br> potential, who, if engaged in active heterosexual relations and has not had a\r<br> hysterectomy or bilateral oophorectomy, would not use one of the following birth\r<br> control methods: tubal ligation, implantable contraception device, oral, injectable or\r<br> transdermal contraceptive, barrier method or sexual activity restricted to\r<br> vasectomized partner.\r<br>\r<br> - The subject withdrew from a previous Fampridine study because of a Serious Adverse\r<br> Event that was possibly, probably or definitely related to Fampridine.\r<br>\r<br> - The subject has a history of seizures or has evidence of past, or possible,\r<br> epileptiform activity on an EEG.\r<br>\r<br> - The subject has either a clinically significant abnormal ECG or laboratory value(s) at\r<br> the Screening Visit, as judged by the Investigator\r<br>\r<br> - The subject has angina, uncontrolled hypertension, clinically significant cardiac\r<br> arrhythmias, or any other clinically significant cardiovascular abnormality, as judged\r<br> by the Investigator.\r<br>\r<br> - The subject has a known allergy to pyridine-containing substances or any of the\r<br> inactive ingredients of the Fampridine tablet\r<br>\r<br> - The subject has received an investigational drug, except for Fampridine- SR (or\r<br> matching placebo) under Protocol MS-F202, within 30 days prior to the Screening Visit;\r<br> or the subject is scheduled to enroll in an investigational drug trial at any time\r<br> during this study.\r<br>\r<br> - The subject has received compounded 4-aminopyridine (4-AP) within 14 days of the\r<br> Screening Visit.\r<br>\r<br> - The subject has had an onset of an MS exacerbation within 30 days prior to the\r<br> Screening Visit, or, if in the judgment of the Investigator, has not stabilized from a\r<br> prior exacerbation episode.\r<br>\r<br> - The subject has started on a concomitant medication regimen for an underlying\r<br> disease/symptom within the past 7 days; or has started an interferon or\r<br> chemotherapeutic agent for multiple sclerosis within the past 4 weeks.\r<br>\r<br> - The subject has a history of drug or alcohol abuse within the past year.\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis;Multiple Sclerosis;Multiple Sclerosis;Multiple Sclerosis", "intervention": "Drug: Fampridine-SR b.i.d. (Twice Daily);Drug: Fampridine-SR b.i.d. (Twice Daily);Drug: Fampridine-SR b.i.d. (Twice Daily);Drug: Fampridine-SR b.i.d. (Twice Daily)", "primary_outcome": "Summary of Treatment Emergent Adverse Events (TEAE).;Summary of Treatment Emergent Adverse Events (TEAE).", "secondary_outcome": "Timed 25 Foot Walk (T25FW);Subject Global Impression (SGI);Clinician Global Impression of Change (CGIC);Expanded Disability Status Scale (EDSS)", "secondary_id": "MS-F202 EXT", "source_support": "Please refer to primary and secondary sponsors", "ethics_review_status": null, "ethics_review_approval_date": null, "ethics_review_contact_name": null, "ethics_review_contact_address": null, "ethics_review_contact_phone": null, "ethics_review_contact_email": null, "results_date_completed": null, "results_url_link": null }, { "trial_id": 3663, "title": "efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis", "summary": null, "published_date": "2008-09-04T00:00:00Z", "discovery_date": "2023-12-06T18:18:22.406452Z", "link": "https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-002627-32", "source": "WHO XML import", "relevant": null, "identifiers": { "euctr": "EUCTR2007-002627-32-CZ" }, "categories": [ { "category_id": 1, "category_description": "Fingolimod, also known as Gilenya is a type of medicine known as a ‘disease-modifying therapy’ that is used to treat adults and children over 10 years of age with highly active relapsing-remitting multiple sclerosis (MS), a disease of the nerves in which inflammation destroys the protective sheath surrounding the nerve cells. ‘Relapsing-remitting’ means that the patient has flare-ups of symptoms (relapses) followed by periods of recovery (remissions). Gilenya is used when the disease remains active despite appropriate treatment with at least one other disease-modifying therapy, or is severe and getting worse rapidly.\r\n\r\nhttps://www.ema.europa.eu/en/medicines/human/EPAR/gilenya", "category_name": "Fingolimod", "category_slug": "fingolimod", "category_terms": [ "fingolimod", "gilenya" ], "article_count": 259 } ], "export_date": "2024-04-19T00:00:00Z", "internal_number": "4507330", "last_refreshed_on": "2015-01-06", "scientific_title": "A double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5mg fingolimod administered orally once daily versus placebo in patients with primary progressive multiple sclerosis.", "primary_sponsor": "Novartis Pharma Services AG", "retrospective_flag": "Yes", "date_registration": null, "source_register": "EU Clinical Trials Register", "recruitment_status": "Not Recruiting", "other_records": "Yes", "inclusion_agemin": null, "inclusion_agemax": null, "inclusion_gender": "<br>Female: yes<br>Male: yes<br>", "date_enrollement": "2009-04-02", "target_size": "970", "study_type": "Interventional clinical trial of medicinal product", "study_design": "Controlled: yes\nRandomised: yes\nOpen: no\nSingle blind: no\nDouble blind: yes\nParallel group: yes\nCross over: no\nOther: no\nIf controlled, specify comparator, Other Medicinial Product: no\nPlacebo: yes\nOther: no\nNumber of treatment arms in the trial: 2", "phase": null, "countries": "Finland;Spain;Ireland;Turkey;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;South Africa;Netherlands;Germany;Sweden", "contact_firstname": "Informacní služba - klin. hodnocení", "contact_lastname": null, "contact_address": "Na Pankráci 1724/129", "contact_email": "[email protected]", "contact_tel": "+420225 775 207", "contact_affiliation": "Novartis s.r.o.", "inclusion_criteria": "Inclusion criteria: <br>General inclusion criteria:\r<br>\r<br>1. male or female\r<br>2. 25 through 65 years of age inclusive \r<br>3. females of childbearing potential must:\r<br>• have a negative pregnancy test at Baseline (prior to randomization) and \r<br>• use simultaneously two forms of effective contraception during the treatment and 3-months after discontinuation of study medication (refer to Section 7.5.9 for details)\r<br>4. sign written informed consent prior to participating in the study \r<br>\r<br>Primary Progressive Multiple sclerosis / specific inclusion criteria :\r<br>\r<br>1. diagnosis of primary progressive multiple sclerosis (according to the 2005 Revised McDonald criteria, Appendix 8):\r<br>• one year of disease progression plus\r<br>• two of the following: \r<br>- positive brain MRI (nine T2 lesions or four or more T2 lesions with positive visual evoked potential) \r<br>- positive spinal cord MRI (2 focal T2 lesions), \r<br>- positive CSF\r<br>• Central review of the diagnostic criteria for PPMS will b erequired prior to randomization (refer to Appendix 9 for details).\r<br>2. duration of disease at Baseline\r<br>• time since first reported symptoms between 2 and 10 years \r<br>3. documented evidence of clinical disability progression in the 2 years prior to Screening\r<br>• clinical disability progression should have been observed in each of the previous 2 years prior to Screening as per clinical judgment of the investigator.\r<br>• in addition, disability progression must be documented by an increase in the EDSS score of at least 0.5 points at any time point during the 2 years prior to Screening. Should documented EDSS scores not be available, a written summary of the clinical evidence of disability progression in the previous 2 years must be submitted for central review. \r<br>4. disability status at Screening (V1 or V2)\r<br>• EDSS score of 3.5-6.0 inclusive \r<br>• pyramidal functional system score of 2 or more \r<br>• 25’TWT less than 30 seconds \r<br><br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range <br>F.1.3 Elderly (>=65 years) no<br>F.1.3.1 Number of subjects for this age range <br>", "exclusion_criteria": "Exclusion criteria: <br>1. history of MS attack/relapse as per clinical judgement of the investigator \r<br>2. progressive disabling neurological disorder, other than PPMS\r<br>3. pure cerebellar progressive syndrome or pure visual progressive syndrome or a pure cognitive progressive syndrome\r<br>4. presence of cervical spinal cord compression on Screening MRI\r<br>5. relevant history of vitamin B12 deficit\r<br>6. history of chronic active disease of the immune system other than MS which may require systemic immunosuppressive treatment or a known immunodeficiency syndrome\r<br>7. history or presence of malignancy (except for successfully treated basal or squamous cell carcinoma of skin)\r<br>8. known or ‘new’ diagnosis of diabetes mellitus (if Screening blood glucose is suspicious for diabetes [=126 mg/dL or =7 mmol/L if fasting and =200 mg/dL or 11.1 mmol/L if random testing] a patient should be further evaluated for diabetes mellitus)\r<br>9. diagnosis of macular edema during Pre-randomization Phase (patients with a history of macular edema will be allowed to enter the study provided that they do not have macular edema at the ophthalmic Screening visit)\r<br>10. evidence of syphilis, borreliosis, HIV, Hepatitis B, Hepatitis C infection or any other active systemic bacterial, viral or fungal infections\r<br>11. have received total lymphoid irradiation or bone marrow transplantation\r<br>12. have been treated with: \r<br>• systemic corticosteroids or adrenocorticotropic hormones (ACTH) within 3 months prior to randomization\r<br>• interferon-beta (IFN-*) or glatiramer acetate within 3 months prior to randomization\r<br>• immunosuppressive medications such as azathioprine or methotrexate within 6 months prior to randomization\r<br>• immunoglobulins and/or monoclonal antibodies within 6 months prior to randomization\r<br>• any mitoxantrone during previous 5 years prior to randomization or evidence of cardiotoxicity following mitoxantrone or mitoxantrone at a total cumulative life-time dose of more than 60 mg/m2\r<br>• cladribine, cyclophosphamide at any time\r<br>13. any medically unstable condition, as assessed by the primary treating physician\r<br>14. any of the following cardiovascular conditions (see enclosed protocol section 5.2)\r<br>15. any of the following pulmonary conditions (see enclosed protocol section 5.2)\r<br>16. any of the following hepatic conditions (see enclosed protocol section 5.2)\r<br>17. any of the following abnormal laboratory values (see enclosed protocol section 5.2)\r<br>18. history of substance abuse (drug or alcohol) or any other factor (i.e., serious psychiatric condition) that may interfere with the subject’s ability to cooperate and comply with the study procedures \r<br>19. unable to undergo MRI scans, including claustrophobia or history of hypersensitivity to gadolinium-DTPA\r<br>20. participation in any clinical research study evaluating another investigational drug or therapy within 6 months prior to randomization\r<br>21. pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.\r<br>22. negative for varicella-zoster virus IgG antibodies at Screening\r<br>23. have received any live or live attenuated vaccines (including for varicella-zoster virus or measles) within 2 months prior to randomization.\r<br><br>", "condition": "Primary progressive multiple sclerosis. <br>MedDRA version: 17.1\nLevel: PT\nClassification code 10063401\nTerm: Primary progressive multiple sclerosis\nSystem Organ Class: 10029205 - Nervous system disorders\n;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]", "intervention": "<br>Trade Name: Gilenya<br>Product Name: Fingolimod<br>Product Code: FTY720D<br>Pharmaceutical Form: Capsule, hard<br>INN or Proposed INN: Fingolimod<br>CAS Number: 162359- 56-0<br>Current Sponsor code: FTY720D<br>Other descriptive name: FTY720<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 0.5-<br>Pharmaceutical form of the placebo: Capsule, hard<br>Route of administration of the placebo: Oral use<br><br>", "primary_outcome": "Main Objective: To evaluate the effect of 0.5mg fingolimod relative to placebo on delaying the time to sustained disability progression.;Secondary Objective: • To evaluate the effect of 0.5mg fingolimod relative to placebo on delaying the time to 3-month sustained disability progression as measured by the EDSS. <br>• To evaluate the effect of fingolimod 0.5mg relative to placebo on the percent change from baseline in brain volume.<br>;Primary end point(s): The primary endpoint is the time to sustained disability progression, which is defined based on three types of events for each subject:<br><br>• 3-month sustained increase of at least 20% from Baseline in the time taken to complete the 25’TWT or<br>• 3-month sustained increase from Baseline in the EDSS score (1 point in patients with Baseline EDSS score 3.5 to 5.0; 0.5 point in patients with Baseline EDSS score of 5.5 or 6.0) or<br>• 3-month sustained increase of at least 20% from Baseline in the time taken to complete the 9-HPT in either one of the hands (dominant or non-dominant)<br><br>Disability progression in this study can be achieved by the occurrence of any of three events (sustained disability progression on 25’TWT, EDSS or 9-HPT) for each subject (See enclosed protocol for further details, section 10.4.).<br><br>In addition, primary efficacy analysis will be based on data from the 654 newly-randomized patients following implementation of FTY720D2306 Protocol Amendment 5 and the placebo patients randomized prior to that.<br>;Timepoint(s) of evaluation of this end point: 36 months", "secondary_outcome": "Secondary end point(s): To evaluate the effect of fingolimod 0.5 mg relative to placebo on delaying the time to 3-month sustained disability progression as measured by the EDSS\r<br>\r<br>To evaluate the effect of fingolimod 0.5 mg relative to placebo on the percent change from baseline in brain volume.;Timepoint(s) of evaluation of this end point: 36 months", "secondary_id": "2007-002627-32", "source_support": "Novartis Pharma Services AG", "ethics_review_status": null, "ethics_review_approval_date": null, "ethics_review_contact_name": null, "ethics_review_contact_address": null, "ethics_review_contact_phone": null, "ethics_review_contact_email": null, "results_date_completed": null, "results_url_link": null }, { "trial_id": 3662, "title": "The role of white and grey matter and meningeal inflammation in multiple sclerosis (MS) and clinically isolated syndromes (CIS) as quantified using [(11)C](R)-PK11195 positron emission tomography (PET) scanning", "summary": null, "published_date": "2008-11-04T00:00:00Z", "discovery_date": "2023-12-06T18:18:22.384543Z", "link": "https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-007394-22", "source": "WHO XML import", "relevant": null, "identifiers": { "euctr": "EUCTR2007-007394-22-GB" }, "categories": [], "export_date": "2024-04-19T00:00:00Z", "internal_number": "9944339", "last_refreshed_on": "2020-10-13", "scientific_title": "The role of white and grey matter and meningeal inflammation in multiple sclerosis (MS) and clinically isolated syndromes (CIS) as quantified using [(11)C](R)-PK11195 positron emission tomography (PET) scanning", "primary_sponsor": "Imperial College London", "retrospective_flag": "Yes", "date_registration": null, "source_register": "EU Clinical Trials Register", "recruitment_status": "Not Recruiting", "other_records": "No", "inclusion_agemin": null, "inclusion_agemax": null, "inclusion_gender": "<br>Female: yes<br>Male: yes<br>", "date_enrollement": "2008-05-22", "target_size": "10", "study_type": "Interventional clinical trial of medicinal product", "study_design": "Controlled: no<br>Randomised: no<br>Open: no<br>Single blind: no<br>Double blind: no<br>Parallel group: no<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: no<br>Other: no<br>", "phase": "Human pharmacology (Phase I): no\nTherapeutic exploratory (Phase II): no\nTherapeutic confirmatory - (Phase III): no\nTherapeutic use (Phase IV): yes", "countries": "United Kingdom", "contact_firstname": null, "contact_lastname": null, "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": null, "inclusion_criteria": "Inclusion criteria: <br>Patients must have a confirmed diagnosis of multiple sclerosis or clinically isolated syndrome<br>Age 18-65<br>Able to give written informed consent<br>Subjects fulfil NICE criteria for use of natalizumab (NICE, 2007)<br><br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) <br>F.1.2.1 Number of subjects for this age range <br>F.1.3 Elderly (>=65 years) <br>F.1.3.1 Number of subjects for this age range <br>", "exclusion_criteria": "Exclusion criteria: <br>Unable to give informed consent<br>Primary progressive MS<br>Patient unable to tolerate MRI scan or PET scan<br>Those that have experienced a relapse or have been treated with steroids (both i.v. and oral) within 1 month. <br><br>", "condition": "Multiple Sclerosis <br>MedDRA version: 9.1\nLevel: HLT\nClassification code 10052785\nTerm: Multiple sclerosis acute and progressive", "intervention": "<br>Trade Name: Tysabri<br>Product Name: Tysabri<br>Pharmaceutical Form: Concentrate for solution for infusion<br><br>", "primary_outcome": "Main Objective: To determine the [(11)C](R)-PK11195 identified inflammatory response to natalizumab therapy (Tysabri) in active relapsing remitting MS.;Secondary Objective: ;Primary end point(s): The identification of 11C-PK11195 binding potential in cortical areas correspondent to B-cell follicles and the changes in the extent of 11C-PK11195 binding potential in the grey matter over one year in the presence of Tysabri therapy.", "secondary_outcome": null, "secondary_id": "PK11195", "source_support": null, "ethics_review_status": "Approved", "ethics_review_approval_date": "2008-08-05", "ethics_review_contact_name": null, "ethics_review_contact_address": null, "ethics_review_contact_phone": null, "ethics_review_contact_email": null, "results_date_completed": "2013-03-10", "results_url_link": null }, { "trial_id": 3661, "title": "Cognitive behavioural therapy (CBT) for adjustment to early stage multiple sclerosis: Manual development and a randomised controlled trial comparing CBT to supportive listening", "summary": null, "published_date": "2008-11-04T00:00:00Z", "discovery_date": "2023-12-06T18:18:22.362741Z", "link": "http://isrctn.com/ISRCTN91377356", "source": "WHO XML import", "relevant": null, "identifiers": { "isrctn": "ISRCTN91377356" }, "categories": [], "export_date": "2024-04-19T00:00:00Z", "internal_number": "4539588", "last_refreshed_on": "2015-01-13", "scientific_title": "", "primary_sponsor": "University of Southampton and Southampton University Hospitals Trust (UK)", "retrospective_flag": "No", "date_registration": null, "source_register": "ISRCTN", "recruitment_status": "Not Recruiting", "other_records": "No", "inclusion_agemin": null, "inclusion_agemax": null, "inclusion_gender": "Both", "date_enrollement": "2008-01-31", "target_size": "100", "study_type": "Interventional", "study_design": "Randomised controlled trial (Not Specified)", "phase": null, "countries": "United Kingdom", "contact_firstname": null, "contact_lastname": null, "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": null, "inclusion_criteria": "Inclusion criteria: 1. Definite diagnosis of MS <br>2. Diagnosed within the last 10 years <br>3. Some degree of ambulation (with aid if necessary). Equivalent to Extended Disability Status Scale (EDSS) <6.5 <br>4. Stabilised on medication (Disease modifying drugs: minimum of 3 months since started; Anti-depressants: stable dose for minimum of 2 months)", "exclusion_criteria": "Exclusion criteria: 1. Gross cognitive impairment that would make participation in therapy problematic or distressing (must score >20 on Telephone Interview for Cognitive Status-Modified to be eligible) <br>2. Serious psychological disorders for whom treatment would be inappropriate (including psychotic disorders of active substance abuse) <br>3. Other co-morbid serious chronic illness (e.g., a malignancy) <br>4. Currently participating in other psychological therapies", "condition": "Multiple sclerosis <br>Nervous System Diseases <br>Multiple sclerosis", "intervention": "Participants will be randomly allocated to either the CBT or Supportive Listening arm. <br><br>CBT arm:<br>Participants in the CBT arm will look at the way that their thoughts, feelings, behaviours and physiology interact and influence how MS affects their lives. The treatment is structured and different topics will be covered in different sessions. The manual consists of 9 chapters which can be used as appropriate to the individual's needs: <br>1. Introduction to adjusting to MS<br>2. Adapting to living with MS<br>3. Setting goals and problem solving<br>4. Symptom management<br>5. How to tackle negative and unhelpful thoughts<br>6. Improving the quality of your sleep<br>7. Managing stress<br>8. Managing social relationships<br>9. Preparing for the future<br>Participants will work with their nurse-therapist in setting tasks or homework to do in between the sessions. Participants have 8 sessions of CBT over 10 weeks. This is delivered by general nurses specially trained as nurse-therapists. 2 sessions are face-to-face, 6 are by telephone. <br><br>Supportive Listening arm:<br>Participants in the Supportive Listening arm will have the opportunity to talk freely, extensively and confidentially about their experiences, thoughts and feeling about MS and its effect on their lives. The listening skills we will use in this trial are based on the theories and counselling techniques of Carl Rogers. These core skills include asking open questions, active listening skills such as minimal encouragers and paraphrasing, empathising, reflecting and summarising. The purpose is to provide the participant the opportunity to talk and express themselves in a non-judgmental, safe environment. The person should experience empathy from the therapist and feel listened to. Participants have 8 sessions of Supportive Listening over 10 weeks. This is delivered by general nurses specially trained as nurse therapists. 2 sessions are face-to-face, 6 are by telephone. <br><br>Questionnaire assessments will be carried out at baseline, mid-therapy, post", "primary_outcome": "The following will be assessed at baseline, mid-therapy, post-therapy and at 6 and 12 months:<br>1. Distress, assessed by the General Health Questionnaire (Goldberg, 1978) <br>2. Work and Social Adjustment, assessed by the Work and Social Adjustment Scale (Mundt et al., 2002)", "secondary_outcome": "The following will be assessed at baseline, post-therapy and at 6 and 12 months, unless specified otherwise: <br>1. Social support, assessed using the Significant Others Scale (SOS; Power et al., 1988) at baseline, post-therapy and at 6 and 12 months <br>2. Beliefs About Emotions (BAE-6; Rimes & Chalder, publication in preparation) <br>3. Illness perceptions, assessed using the Brief Illness Perception Questionnaire (B-IPQ; Broadbent et al., 2006) <br>4. Cognitive and Behavioural responses to symptoms (CBSRQ; Moss-Morris et al., publication in preperation) <br>5. Acceptance, assessed by the Acceptance of Chronic Health Conditions (ACHC) Scale (Stuifbergen et al., in press) <br>6. Dyadic adjustment, assessed by the Dyadic Adjustment Scale (DAS-4; Sabourin et al., 2005) at baseline and post-therapy<br>7. Dysfunctional beliefs, assessed by the Psychological Vulnerability Scale (PVS; Sinclair & Wallston, 1999) <br>8. Health status, assessed by Euroqol (Curtis & Netten, 2006) at baseline, 6 and 12 months<br>9. Health service usage/costs, assessed using the Client Service Receipt Inventory (CSRI, Beecham & Knapp, 2001) at baseline, 6 and 12 months", "secondary_id": "RHM MED 0726", "source_support": "Multiple Sclerosis Society (refs: 839/06 and 072/07)", "ethics_review_status": null, "ethics_review_approval_date": null, "ethics_review_contact_name": null, "ethics_review_contact_address": null, "ethics_review_contact_phone": null, "ethics_review_contact_email": null, "results_date_completed": null, "results_url_link": null }, { "trial_id": 3660, "title": "Telephone Intervention for Pain Study (TIPS)", "summary": null, "published_date": "2008-04-18T00:00:00Z", "discovery_date": "2023-12-06T18:18:22.329616Z", "link": "http://clinicaltrials.gov/show/NCT00663663", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT00663663" }, "categories": [], "export_date": "2024-04-19T00:00:00Z", "internal_number": "4640340", "last_refreshed_on": "2015-02-19", "scientific_title": "Efficacy of Telephone-Delivered Cognitive Behavioral Therapy for Chronic Pain", "primary_sponsor": "University of Washington", "retrospective_flag": "Yes", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Not recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "N/A", "inclusion_gender": "Both", "date_enrollement": "2009-09-19", "target_size": "207", "study_type": "Interventional", "study_design": "Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment", "phase": "N/A", "countries": "United States", "contact_firstname": "", "contact_lastname": "Dawn M. Ehde, Ph.D", "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": "University of Washington", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - Definitive diagnosis of acquired amputation (AMP), multiple sclerosis (MS), or spinal\r<br> cord injury (SCI) confirmed by participants' primary care physicians\r<br>\r<br> - Average pain intensity in the past month of greater than 3 on 0-10 numeric rating\r<br> scale;\r<br>\r<br> - Pain is either worse or started since the onset of the disability;\r<br>\r<br> - Pain of at least six months duration, with pain reportedly present greater than or\r<br> equal to half of the days in the past six months;\r<br>\r<br> - Read, write and understand English;\r<br>\r<br> - Must be able to communicate over the phone (i.e., must be verbal);\r<br>\r<br> - Age 18 years or older.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Cognitive impairment defined as one or more errors on the Six-Item screener (Callahan\r<br> et al., 2002).\r<br>\r<br> - Current or previous participation in a psychological treatment for pain (obtained via\r<br> self-report).\r<br>\r<br> - Current participation in a psychological treatment for any reason on a regular\r<br> basis(obtained via self-report).\r<br>", "exclusion_criteria": null, "condition": "Chronic Pain;Multiple Sclerosis;Amputation;Spinal Cord Injury", "intervention": "Behavioral: Telephone-Delivered Intervention 1;Behavioral: Telephone-Delivered Intervention 2", "primary_outcome": "Average pain intensity", "secondary_outcome": "Physical Functioning-Brief Pain Inventory (Cleeland & Ryan, 1994);Patient Health Questionnaire-8 (PHQ-8) (Kroenke & Spitzer, 2002);Pain Catastrophizing Scale (Sullivan et al., 1995)", "secondary_id": "R01HD057916-04;33597-G", "source_support": "Please refer to primary and secondary sponsors", "ethics_review_status": null, "ethics_review_approval_date": null, "ethics_review_contact_name": null, "ethics_review_contact_address": null, "ethics_review_contact_phone": null, "ethics_review_contact_email": null, "results_date_completed": null, "results_url_link": null }, { "trial_id": 3659, "title": "Evaluate Early Glatiramer Acetate Treatment in Delaying Conversion to Clinically Definite Multiple Sclerosis of Subjects Presenting With Clinically Isolated Syndrome", "summary": null, "published_date": "2008-04-22T00:00:00Z", "discovery_date": "2023-12-06T18:18:22.303217Z", "link": "https://clinicaltrials.gov/show/NCT00666224", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT00666224" }, "categories": [], "export_date": "2024-04-19T00:00:00Z", "internal_number": "6489823", "last_refreshed_on": "2017-10-19", "scientific_title": "A Multinational, Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Effect of Early Glatiramer Acetate Treatment in Delaying the Conversion to Clinically Definite Multiple Sclerosis (CDMS) of Subjects Presenting With Clinically Isolated Syndrome (CIS)", "primary_sponsor": "Teva Pharmaceutical Industries", "retrospective_flag": "No", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Not recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "45 Years", "inclusion_gender": "All", "date_enrollement": "2004-01-19", "target_size": "481", "study_type": "Interventional", "study_design": null, "phase": "Phase 3", "countries": "Argentina;Australia;Austria;Denmark;Finland;France;Germany;Hungary;Israel;Italy;New Zealand;Norway;Romania;Spain;Sweden;United Kingdom;United States;Argentina;Australia;Austria;Denmark;Finland;France;Germany;Hungary;Israel;Italy;New Zealand;Norway;Romania;Spain;Sweden;United Kingdom;United States;Argentina;Australia;Austria;Denmark;Finland;France;Germany;Hungary;Israel;Italy;New Zealand;Norway;Romania;Spain;Sweden;United Kingdom;United States;Argentina;Australia;Austria;Denmark;Finland;France;Germany;Hungary;Israel;Italy;New Zealand;Norway;Romania;Spain;Sweden;United Kingdom;United States", "contact_firstname": null, "contact_lastname": null, "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": null, "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> 1. The subject must have undergone a single clinical attack.\r<br>\r<br> 2. The subject must have a unifocal clinical presentation.\r<br>\r<br> 3. The subject should be enrolled within the period of 90 days after onset of a single\r<br> unifocal clinical attack (index attack).\r<br>\r<br> 4. There must be 2 or more cerebral lesions highly suspicious of multiple sclerosis (MS)\r<br> on the screening Magnetic Resonance Imaging (MRI), measuring 6mm or more in diameter.\r<br>\r<br> 5. Subjects must be between the ages of 18 and 45 years inclusive.\r<br>\r<br> 6. Subjects must not have taken corticosteroids within the 30 days prior to the MRI at\r<br> the baseline visit.\r<br>\r<br> 7. Subjects may be male or female. Women of child-bearing potential must practice a\r<br> medically acceptable method of birth control. Acceptable methods include oral\r<br> contraceptive, contraceptive patch, long-acting injectable contraceptive, or\r<br> double-barrier method (condom or intrauterine device with spermicide).\r<br>\r<br> 8. The subjects must be willing and able to give written informed consent, prior to\r<br> entering the study.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> 1. Multifocal clinical presentation.\r<br>\r<br> 2. Diseases other than MS responsible for the clinical/MRI presentation. The following\r<br> laboratory tests must be part of the subject's medical history for differential\r<br> diagnosis of clinically isolated syndrome (CIS): erythrocyte sedimentation rate (ESR),\r<br> antinuclear antibody (ANA), complement (C3, C4) and anticardiolipin IgG - IgM. In the\r<br> event that the results of these tests are inconclusive, the following additional tests\r<br> may be requested by the Eligibility Evaluation Committee: syphilis screening, vitamin\r<br> B12 and folic acid. In the case of spinal cord CIS presentation, a spinal cord MRI is\r<br> required for confirmation of diagnosis in the medical history of the subject.\r<br>\r<br> 3. Use of experimental or investigational drugs, including IV immunoglobulin, and/or\r<br> participation in an investigational drug study within 6 months prior to study entry.\r<br>\r<br> 4. Use of interferon agents within 6 months prior to the screening visit.\r<br>\r<br> 5. Chronic corticosteroid treatment (more than 30 consecutive days) in the 6 months prior\r<br> to study entry.\r<br>\r<br> 6. Pregnancy or breast feeding.\r<br>\r<br> 7. Subjects who experience a relapse between the screening (month -1) and baseline (month\r<br> 0) visits.\r<br>\r<br> 8. Life-threatening or other clinically significant disease.\r<br>\r<br> 9. A medical or psychiatric condition that affects the subject's ability to give informed\r<br> consent, or to complete the study, or if the subject is considered by the treating\r<br> neurologist/physician to be, for any other reason, an unsuitable candidate for this\r<br> study.\r<br>\r<br> 10. A known history of sensitivity to mannitol.\r<br>\r<br> 11. A known history of sensitivity to gadolinium.\r<br>\r<br> 12. Inability to successfully undergo MRI scanning.\r<br> ;\r<br> Inclusion Criteria:\r<br>\r<br> 1. The subject must have undergone a single clinical attack.\r<br>\r<br> 2. The subject must have a unifocal clinical presentation.\r<br>\r<br> 3. The subject should be enrolled within the period of 90 days after onset of a single\r<br> unifocal clinical attack (index attack).\r<br>\r<br> 4. There must be 2 or more cerebral lesions highly suspicious of multiple sclerosis (MS)\r<br> on the screening Magnetic Resonance Imaging (MRI), measuring 6mm or more in diameter.\r<br>\r<br> 5. Subjects must be between the ages of 18 and 45 years inclusive.\r<br>\r<br> 6. Subjects must not have taken corticosteroids within the 30 days prior to the MRI at\r<br> the baseline visit.\r<br>\r<br> 7. Subjects may be male or female. Women of child-bearing potential must practice a\r<br> medically acceptable method of birth control. Acceptable methods include oral\r<br> contraceptive, contraceptive patch, long-acting injectable contraceptive, or\r<br> double-barrier method (condom or intrauterine device with spermicide).\r<br>\r<br> 8. The subjects must be willing and able to give written informed consent, prior to\r<br> entering the study.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> 1. Multifocal clinical presentation.\r<br>\r<br> 2. Diseases other than MS responsible for the clinical/MRI presentation. The following\r<br> laboratory tests must be part of the subject's medical history for differential\r<br> diagnosis of clinically isolated syndrome (CIS): erythrocyte sedimentation rate (ESR),\r<br> antinuclear antibody (ANA), complement (C3, C4) and anticardiolipin IgG - IgM. In the\r<br> event that the results of these tests are inconclusive, the following additional tests\r<br> may be requested by the Eligibility Evaluation Committee: syphilis screening, vitamin\r<br> B12 and folic acid. In the case of spinal cord CIS presentation, a spinal cord MRI is\r<br> required for confirmation of diagnosis in the medical history of the subject.\r<br>\r<br> 3. Use of experimental or investigational drugs, including IV immunoglobulin, and/or\r<br> participation in an investigational drug study within 6 months prior to study entry.\r<br>\r<br> 4. Use of interferon agents within 6 months prior to the screening visit.\r<br>\r<br> 5. Chronic corticosteroid treatment (more than 30 consecutive days) in the 6 months prior\r<br> to study entry.\r<br>\r<br> 6. Pregnancy or breast feeding.\r<br>\r<br> 7. Subjects who experience a relapse between the screening (month -1) and baseline (month\r<br> 0) visits.\r<br>\r<br> 8. Life-threatening or other clinically significant disease.\r<br>\r<br> 9. A medical or psychiatric condition that affects the subject's ability to give informed\r<br> consent, or to complete the study, or if the subject is considered by the treating\r<br> neurologist/physician to be, for any other reason, an unsuitable candidate for this\r<br> study.\r<br>\r<br> 10. A known history of sensitivity to mannitol.\r<br>\r<br> 11. A known history of sensitivity to gadolinium.\r<br>\r<br> 12. Inability to successfully undergo MRI scanning.\r<br> ;\r<br> Inclusion Criteria:\r<br>\r<br> 1. The subject must have undergone a single clinical attack.\r<br>\r<br> 2. The subject must have a unifocal clinical presentation.\r<br>\r<br> 3. The subject should be enrolled within the period of 90 days after onset of a single\r<br> unifocal clinical attack (index attack).\r<br>\r<br> 4. There must be 2 or more cerebral lesions highly suspicious of multiple sclerosis (MS)\r<br> on the screening Magnetic Resonance Imaging (MRI), measuring 6mm or more in diameter.\r<br>\r<br> 5. Subjects must be between the ages of 18 and 45 years inclusive.\r<br>\r<br> 6. Subjects must not have taken corticosteroids within the 30 days prior to the MRI at\r<br> the baseline visit.\r<br>\r<br> 7. Subjects may be male or female. Women of child-bearing potential must practice a\r<br> medically acceptable method of birth control. Acceptable methods include oral\r<br> contraceptive, contraceptive patch, long-acting injectable contraceptive, or\r<br> double-barrier method (condom or intrauterine device with spermicide).\r<br>\r<br> 8. The subjects must be willing and able to give written informed consent, prior to\r<br> entering the study.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> 1. Multifocal clinical presentation.\r<br>\r<br> 2. Diseases other than MS responsible for the clinical/MRI presentation. The following\r<br> laboratory tests must be part of the subject's medical history for differential\r<br> diagnosis of clinically isolated syndrome (CIS): erythrocyte sedimentation rate (ESR),\r<br> antinuclear antibody (ANA), complement (C3, C4) and anticardiolipin IgG - IgM. In the\r<br> event that the results of these tests are inconclusive, the following additional tests\r<br> may be requested by the Eligibility Evaluation Committee: syphilis screening, vitamin\r<br> B12 and folic acid. In the case of spinal cord CIS presentation, a spinal cord MRI is\r<br> required for confirmation of diagnosis in the medical history of the subject.\r<br>\r<br> 3. Use of experimental or investigational drugs, including IV immunoglobulin, and/or\r<br> participation in an investigational drug study within 6 months prior to study entry.\r<br>\r<br> 4. Use of interferon agents within 6 months prior to the screening visit.\r<br>\r<br> 5. Chronic corticosteroid treatment (more than 30 consecutive days) in the 6 months prior\r<br> to study entry.\r<br>\r<br> 6. Pregnancy or breast feeding.\r<br>\r<br> 7. Subjects who experience a relapse between the screening (month -1) and baseline (month\r<br> 0) visits.\r<br>\r<br> 8. Life-threatening or other clinically significant disease.\r<br>\r<br> 9. A medical or psychiatric condition that affects the subject's ability to give informed\r<br> consent, or to complete the study, or if the subject is considered by the treating\r<br> neurologist/physician to be, for any other reason, an unsuitable candidate for this\r<br> study.\r<br>\r<br> 10. A known history of sensitivity to mannitol.\r<br>\r<br> 11. A known history of sensitivity to gadolinium.\r<br>\r<br> 12. Inability to successfully undergo MRI scanning.\r<br> ;\r<br> Inclusion Criteria:\r<br>\r<br> 1. The subject must have undergone a single clinical attack.\r<br>\r<br> 2. The subject must have a unifocal clinical presentation.\r<br>\r<br> 3. The subject should be enrolled within the period of 90 days after onset of a single\r<br> unifocal clinical attack (index attack).\r<br>\r<br> 4. There must be 2 or more cerebral lesions highly suspicious of multiple sclerosis (MS)\r<br> on the screening Magnetic Resonance Imaging (MRI), measuring 6mm or more in diameter.\r<br>\r<br> 5. Subjects must be between the ages of 18 and 45 years inclusive.\r<br>\r<br> 6. Subjects must not have taken corticosteroids within the 30 days prior to the MRI at\r<br> the baseline visit.\r<br>\r<br> 7. Subjects may be male or female. Women of child-bearing potential must practice a\r<br> medically acceptable method of birth control. Acceptable methods include oral\r<br> contraceptive, contraceptive patch, long-acting injectable contraceptive, or\r<br> double-barrier method (condom or intrauterine device with spermicide).\r<br>\r<br> 8. The subjects must be willing and able to give written informed consent, prior to\r<br> entering the study.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> 1. Multifocal clinical presentation.\r<br>\r<br> 2. Diseases other than MS responsible for the clinical/MRI presentation. The following\r<br> laboratory tests must be part of the subject's medical history for differential\r<br> diagnosis of clinically isolated syndrome (CIS): erythrocyte sedimentation rate (ESR),\r<br> antinuclear antibody (ANA), complement (C3, C4) and anticardiolipin IgG - IgM. In the\r<br> event that the results of these tests are inconclusive, the following additional tests\r<br> may be requested by the Eligibility Evaluation Committee: syphilis screening, vitamin\r<br> B12 and folic acid. In the case of spinal cord CIS presentation, a spinal cord MRI is\r<br> required for confirmation of diagnosis in the medical history of the subject.\r<br>\r<br> 3. Use of experimental or investigational drugs, including IV immunoglobulin, and/or\r<br> participation in an investigational drug study within 6 months prior to study entry.\r<br>\r<br> 4. Use of interferon agents within 6 months prior to the screening visit.\r<br>\r<br> 5. Chronic corticosteroid treatment (more than 30 consecutive days) in the 6 months prior\r<br> to study entry.\r<br>\r<br> 6. Pregnancy or breast feeding.\r<br>\r<br> 7. Subjects who experience a relapse between the screening (month -1) and baseline (month\r<br> 0) visits.\r<br>\r<br> 8. Life-threatening or other clinically significant disease.\r<br>\r<br> 9. A medical or psychiatric condition that affects the subject's ability to give informed\r<br> consent, or to complete the study, or if the subject is considered by the treating\r<br> neurologist/physician to be, for any other reason, an unsuitable candidate for this\r<br> study.\r<br>\r<br> 10. A known history of sensitivity to mannitol.\r<br>\r<br> 11. A known history of sensitivity to gadolinium.\r<br>\r<br> 12. Inability to successfully undergo MRI scanning.\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis;Multiple Sclerosis;Multiple Sclerosis;Multiple Sclerosis", "intervention": "Drug: Glatiramer Acetate (DB);Drug: Placebo;Drug: Glatiramer Acetate (OL);Drug: Glatiramer Acetate (DB);Drug: Placebo;Drug: Glatiramer Acetate (OL);Drug: Glatiramer Acetate (DB);Drug: Placebo;Drug: Glatiramer Acetate (OL);Drug: Glatiramer Acetate (DB);Drug: Placebo;Drug: Glatiramer Acetate (OL)", "primary_outcome": "Time to Clinically Definite Multiple Sclerosis (CDMS) Conversion;Twenty-fifth Percentile (25%) Kaplan-Meier Estimates for Time From Randomization to Conversion to Clinically Definite Multiple Sclerosis (CDMS) During the Double-blind Period;Time to Clinically Definite Multiple Sclerosis (CDMS) Conversion;Twenty-fifth Percentile (25%) Kaplan-Meier Estimates for Time From Randomization to Conversion to Clinically Definite Multiple Sclerosis (CDMS) During the Double-blind Period", "secondary_outcome": "Number of New T2 Brain Lesions Observed at the Last Observed Value (LOV) in the Double-blind Period;Change From Baseline to Last Observed Value (LOV) in T2 Brain Lesion Volume in the Double-blind Period;Percentage Change in Brain Volume From Baseline to the Last Observed Value (LOV) During the Double-blind Period Using the Structural Image Evaluation of Normalized Atrophy (SIENA) Technique;Percentage of Participants Who Converted to Clinically Definite Multiple Sclerosis (CDMS) During the Double-blind Period", "secondary_id": "GA 9010", "source_support": "Please refer to primary and secondary sponsors", "ethics_review_status": null, "ethics_review_approval_date": null, "ethics_review_contact_name": null, "ethics_review_contact_address": null, "ethics_review_contact_phone": null, "ethics_review_contact_email": null, "results_date_completed": null, "results_url_link": null }, { "trial_id": 3658, "title": "Minocycline in Clinically Isolated Syndromes (CIS)", "summary": null, "published_date": "2008-04-23T00:00:00Z", "discovery_date": "2023-12-06T18:18:22.278883Z", "link": "https://clinicaltrials.gov/show/NCT00666887", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT00666887" }, "categories": [], "export_date": "2024-04-19T00:00:00Z", "internal_number": "6611343", "last_refreshed_on": "2017-12-16", "scientific_title": "A Phase III Double-blind, Randomized, Placebo-controlled Trial of Minocycline in Clinically Isolated Syndromes (CIS) and Early Single Relapse Multiple Sclerosis (MS)", "primary_sponsor": "Dr. Luanne Metz", "retrospective_flag": "Yes", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Not recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "60 Years", "inclusion_gender": "All", "date_enrollement": "2009-01-19", "target_size": "142", "study_type": "Interventional", "study_design": "Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).", "phase": "Phase 3", "countries": "Canada;Canada;Canada;Canada;Canada", "contact_firstname": "; ; ; ;", "contact_lastname": "Luanne Metz, MD;Luanne Metz, MD;Luanne Metz, MD;Luanne Metz, MD;Luanne Metz, MD", "contact_address": null, "contact_email": ";;;;", "contact_tel": ";;;;", "contact_affiliation": "University of Calgary;University of Calgary;University of Calgary;University of Calgary;University of Calgary", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - Age between 18 and 60 years.\r<br>\r<br> - First focal clinical episode suggestive of demyelinating disease within the previous\r<br> 180 days (measured from onset of the first symptom to treatment start), based on the\r<br> appearance of a neurological abnormality, present for at least 24 hours.\r<br>\r<br> - Objective clinical evidence must be present or documented. Patients will be included\r<br> irrespective of whether the first clinical demyelinating episode was monosymptomatic\r<br> (i.e. clinical evidence of a single lesion) or polysymptomatic (i.e. clinical evidence\r<br> of more than one lesion).\r<br>\r<br> - At least two lesions on the T2-weighted brain MRI* scan at least one of which is ovoid\r<br> or periventricular or infratentorial. MRI eligibility will be determined centrally by\r<br> the UBC MS/MRI Research Group.*One lesion on spinal MRI may substitute for one brain\r<br> lesion as per the 2005 McDonald Criteria.\r<br>\r<br> - Sexually active women of child-bearing potential must agree to use adequate\r<br> contraception.\r<br>\r<br> - Written informed consent\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Any disease other than MS that could better explain the patient's signs and symptoms.\r<br>\r<br> - Any previous clinical event reasonably attributable to acute demyelination, regardless\r<br> of whether medical attention was obtained.\r<br>\r<br> - Complete transverse myelitis or bilateral optic neuritis. A waiver can be obtained for\r<br> bilateral optic neuritis but must be obtained prior to randomization. Waivers must be\r<br> approved by 3 neurologists including a member of the Clinical Eligibility / Endpoint\r<br> Committee, a member of the DSMC, and by an experienced MS neurophthalmologist.\r<br> ;\r<br> Inclusion Criteria:\r<br>\r<br> - Age between 18 and 60 years.\r<br>\r<br> - First focal clinical episode suggestive of demyelinating disease within the previous\r<br> 180 days (measured from onset of the first symptom to treatment start), based on the\r<br> appearance of a neurological abnormality, present for at least 24 hours.\r<br>\r<br> - Objective clinical evidence must be present or documented. Patients will be included\r<br> irrespective of whether the first clinical demyelinating episode was monosymptomatic\r<br> (i.e. clinical evidence of a single lesion) or polysymptomatic (i.e. clinical evidence\r<br> of more than one lesion).\r<br>\r<br> - At least two lesions on the T2-weighted brain MRI* scan at least one of which is ovoid\r<br> or periventricular or infratentorial. MRI eligibility will be determined centrally by\r<br> the UBC MS/MRI Research Group.*One lesion on spinal MRI may substitute for one brain\r<br> lesion as per the 2005 McDonald Criteria.\r<br>\r<br> - Sexually active women of child-bearing potential must agree to use adequate\r<br> contraception.\r<br>\r<br> - Written informed consent\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Any disease other than MS that could better explain the patient's signs and symptoms.\r<br>\r<br> - Any previous clinical event reasonably attributable to acute demyelination, regardless\r<br> of whether medical attention was obtained.\r<br>\r<br> - Complete transverse myelitis or bilateral optic neuritis. A waiver can be obtained for\r<br> bilateral optic neuritis but must be obtained prior to randomization. Waivers must be\r<br> approved by 3 neurologists including a member of the Clinical Eligibility / Endpoint\r<br> Committee, a member of the DSMC, and by an experienced MS neurophthalmologist.\r<br> ;\r<br> Inclusion Criteria:\r<br>\r<br> - Age between 18 and 60 years.\r<br>\r<br> - First focal clinical episode suggestive of demyelinating disease within the previous\r<br> 180 days (measured from onset of the first symptom to treatment start), based on the\r<br> appearance of a neurological abnormality, present for at least 24 hours.\r<br>\r<br> - Objective clinical evidence must be present or documented. Patients will be included\r<br> irrespective of whether the first clinical demyelinating episode was monosymptomatic\r<br> (i.e. clinical evidence of a single lesion) or polysymptomatic (i.e. clinical evidence\r<br> of more than one lesion).\r<br>\r<br> - At least two lesions on the T2-weighted brain MRI* scan at least one of which is ovoid\r<br> or periventricular or infratentorial. MRI eligibility will be determined centrally by\r<br> the UBC MS/MRI Research Group.*One lesion on spinal MRI may substitute for one brain\r<br> lesion as per the 2005 McDonald Criteria.\r<br>\r<br> - Sexually active women of child-bearing potential must agree to use adequate\r<br> contraception.\r<br>\r<br> - Written informed consent\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Any disease other than MS that could better explain the patient's signs and symptoms.\r<br>\r<br> - Any previous clinical event reasonably attributable to acute demyelination, regardless\r<br> of whether medical attention was obtained.\r<br>\r<br> - Complete transverse myelitis or bilateral optic neuritis. A waiver can be obtained for\r<br> bilateral optic neuritis but must be obtained prior to randomization. Waivers must be\r<br> approved by 3 neurologists including a member of the Clinical Eligibility / Endpoint\r<br> Committee, a member of the DSMC, and by an experienced MS neurophthalmologist.\r<br> ;\r<br> Inclusion Criteria:\r<br>\r<br> - Age between 18 and 60 years.\r<br>\r<br> - First focal clinical episode suggestive of demyelinating disease within the previous\r<br> 180 days (measured from onset of the first symptom to treatment start), based on the\r<br> appearance of a neurological abnormality, present for at least 24 hours.\r<br>\r<br> - Objective clinical evidence must be present or documented. Patients will be included\r<br> irrespective of whether the first clinical demyelinating episode was monosymptomatic\r<br> (i.e. clinical evidence of a single lesion) or polysymptomatic (i.e. clinical evidence\r<br> of more than one lesion).\r<br>\r<br> - At least two lesions on the T2-weighted brain MRI* scan at least one of which is ovoid\r<br> or periventricular or infratentorial. MRI eligibility will be determined centrally by\r<br> the UBC MS/MRI Research Group.*One lesion on spinal MRI may substitute for one brain\r<br> lesion as per the 2005 McDonald Criteria.\r<br>\r<br> - Sexually active women of child-bearing potential must agree to use adequate\r<br> contraception.\r<br>\r<br> - Written informed consent\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Any disease other than MS that could better explain the patient's signs and symptoms.\r<br>\r<br> - Any previous clinical event reasonably attributable to acute demyelination, regardless\r<br> of whether medical attention was obtained.\r<br>\r<br> - Complete transverse myelitis or bilateral optic neuritis. A waiver can be obtained for\r<br> bilateral optic neuritis but must be obtained prior to randomization. Waivers must be\r<br> approved by 3 neurologists including a member of the Clinical Eligibility / Endpoint\r<br> Committee, a member of the DSMC, and by an experienced MS neurophthalmologist.\r<br>", "exclusion_criteria": null, "condition": "Clinically Isolated Syndromes;Early Single Relapse of Multiple Sclerosis;Clinically Isolated Syndromes;Early Single Relapse of Multiple Sclerosis;Clinically Isolated Syndromes;Early Single Relapse of Multiple Sclerosis;Clinically Isolated Syndromes;Early Single Relapse of Multiple Sclerosis", "intervention": "Drug: Minocycline;Drug: Placebo;Drug: Minocycline;Drug: Placebo;Drug: Minocycline;Drug: Placebo;Drug: Minocycline;Drug: Placebo", "primary_outcome": "To demonstrate that 100 mg of oral minocycline twice daily reduces the conversion of CIS to McDonald Criteria MS (McDMS) by an absolute 25% as compared to placebo, over a 6 month follow-up period.;To demonstrate that 100 mg of oral minocycline twice daily reduces the conversion of CIS to McDonald Criteria MS (McDMS) by an absolute 25% as compared to placebo, over a 6 month follow-up period.;To demonstrate that 100 mg of oral minocycline twice daily reduces the conversion of CIS to McDonald Criteria MS (McDMS) by an absolute 25% as compared to placebo, over a 6 month follow-up period.", "secondary_outcome": "To confirm that this early treatment benefit is maintained at two years.;Change in T2 lesion volume;Cumulative number of enhancing T1 lesions;cumulative combined unique lesions (new enhancing T1-weighted lesions plus new and enlarging T2 lesions, without lesion double counting)", "secondary_id": "Health Canada Control #120007;Grant ID # 21569", "source_support": "Please refer to primary and secondary sponsors", "ethics_review_status": null, "ethics_review_approval_date": null, "ethics_review_contact_name": null, "ethics_review_contact_address": null, "ethics_review_contact_phone": null, "ethics_review_contact_email": null, "results_date_completed": null, "results_url_link": null }, { "trial_id": 3657, "title": "Simvastatin in Relapsing Remitting Multiple Sclerosis (RRMS) Patients Using Avonex Compared to Placebo", "summary": null, "published_date": "2008-04-27T00:00:00Z", "discovery_date": "2023-12-06T18:18:22.254914Z", "link": "http://clinicaltrials.gov/show/NCT00668343", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT00668343" }, "categories": [ { "category_id": 9, "category_description": "", "category_name": "Simvastatin", "category_slug": "simvastatin", "category_terms": [ "simvastatin" ], "article_count": 1 } ], "export_date": "2024-04-19T00:00:00Z", "internal_number": "4640699", "last_refreshed_on": "2015-02-19", "scientific_title": null, "primary_sponsor": "Tehran University of Medical Sciences", "retrospective_flag": "No", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Not recruiting", "other_records": "No", "inclusion_agemin": "15 Years", "inclusion_agemax": "60 Years", "inclusion_gender": "Both", "date_enrollement": "2005-04-19", "target_size": "80", "study_type": "Interventional", "study_design": "Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment", "phase": "Phase 3", "countries": "Iran, Islamic Republic of", "contact_firstname": "", "contact_lastname": "Mansooreh Togha, MD", "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": "TUMS", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> 1. edss<5\r<br>\r<br> 2. >=1 attack in last year\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> 1. >2 attacks in study\r<br>\r<br> 2. drug complication\r<br>", "exclusion_criteria": null, "condition": "Relapsing Remitting Multiple Sclerosis", "intervention": "Drug: simvastatin;Drug: placebo", "primary_outcome": "attack number", "secondary_outcome": null, "secondary_id": "83/132/9388;132/9388", "source_support": "Please refer to primary and secondary sponsors", "ethics_review_status": null, "ethics_review_approval_date": null, "ethics_review_contact_name": null, "ethics_review_contact_address": null, "ethics_review_contact_phone": null, "ethics_review_contact_email": null, "results_date_completed": null, "results_url_link": null } ] }