Trial List
List all clinical trials by discovery date. Accepts regular expressions in search.
GET /trials/?format=api&page=73
{ "count": 4829, "next": "http://api.gregory-ms.com/trials/?format=api&page=74", "previous": "http://api.gregory-ms.com/trials/?format=api&page=72", "results": [ { "trial_id": 3626, "title": "An Extension Study of LAQ/5062 Exploring the Long Term Safety, Tolerability and Clinical Effect Parameters During the Disease", "summary": null, "published_date": "2008-02-09T00:00:00Z", "discovery_date": "2023-12-06T18:18:21.533298Z", "link": "https://clinicaltrials.gov/show/NCT00745615", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT00745615" }, "categories": [], "export_date": "2024-04-19T00:00:00Z", "internal_number": "10205856", "last_refreshed_on": "2020-12-12", "scientific_title": "An Active Extension of LAQ/5062 Study. A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group Study to Evaluate the Safety, Tolerability and Efficacy of Two Doses (0.3 mg and 0.6 mg) of Laquinimod, Orally Administered in Relapsing Remitting (R-R) Multiple Sclerosis (MS) Subjects (Study LAQ/5063 Active Double-Blind Phase) Followed by an Open Label Phase of Laquinimod 0.6 mg Daily (LAQ/5063 OL)", "primary_sponsor": "Teva Pharmaceutical Industries, Ltd.", "retrospective_flag": "No", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Not recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "50 Years", "inclusion_gender": "All", "date_enrollement": "2005-12-07", "target_size": "257", "study_type": "Interventional", "study_design": "Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).", "phase": "Phase 2", "countries": "Czechia;Germany;Hungary;Israel;Italy;Poland;Russian Federation;Spain;United Kingdom;Czechia;Germany;Hungary;Israel;Italy;Poland;Russian Federation;Spain;United Kingdom;Czech Republic", "contact_firstname": "", "contact_lastname": "Giancarlo Comi", "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": "Instituto Scientifico Fondazione Centro S. Raffaele, Milan, Italy", "inclusion_criteria": "<br> Inclusion Criteria - Participants must have completed the 36 weeks of treatment (completion\r<br> of the full 36 weeks or as requested by the Sponsor) of the active double-blind phase. -\r<br> Women of childbearing potential (for example, women who were not postmenopausal or\r<br> surgically sterilized) must have practiced 2 acceptable methods of birth control for the\r<br> duration of the study and until 30 days after the last dose of study medication (acceptable\r<br> methods of birth control in this open-label extension phase included intrauterine devices,\r<br> barrier methods [condom or diaphragm with spermicide], and hormonal methods of birth\r<br> control [for example, oral contraceptive, contraceptive patch, and long-acting injectable\r<br> contraceptive]). - Participants must have been willing and able to comply with the protocol\r<br> requirements for the duration of LAQ/5063 OL. - Participants must have given signed,\r<br> written informed consent prior to entering LAQ/5063 OL. - For the 36 months further\r<br> extension: Participants must have completed the 24 months of treatment of the first period\r<br> of the open label phase. Exclusion Criteria - For the 36 month further extension: Premature\r<br> discontinuation from LAQ/5063 OL phase prior to completion of 24 months of treatment\r<br> period. - Pregnancy or breastfeeding. - Participants with clinically significant or\r<br> unstable medical or surgical condition, detected or worsened during the active double-blind\r<br> phase of LAQ/5063, which would have precluded safe and complete study participation. - Use\r<br> of experimental drugs, immunosuppressive drugs, and/or participation in clinical studies\r<br> within the period from termination of LAQ/5063 active double-blind phase to LAQ/5063 OL. -\r<br> Previous treatment with immunomodulators with the exception of laquinimod (including\r<br> interferon [IFN] 1a and 1b, glatiramer acetate, and intravenous [IV] immunoglobulin) within\r<br> 2 months prior to entering the open-label phase for those subjects who had a time gap\r<br> between termination of LAQ/5063 active double-blind phase to LAQ/5063 OL. - Use of\r<br> corticosteroids within 30 days prior to entering the open-label phase, except for IV\r<br> methylprednisolone 1 grams/day for a maximum of 3 days, in the period from termination of\r<br> LAQ/5063 active double-blind phase to LAQ/5063 OL. - Use of potent inhibitors of cytochrome\r<br> P3A4 (CYP3A4) within 2 weeks prior to LAQ/5063 OL and/or use of fluoxetine 1 month prior to\r<br> entering LAQ/5063 OL, in the period from termination of LAQ/5063 active double-blind phase\r<br> to LAQ/5063 OL. - Use of the following substrates of cytochrome P1A2 (CYP1A2): theophylline\r<br> and/or warfarin within 2 weeks prior to entering LAQ/5063 OL, in the period from\r<br> termination of LAQ/5063 active double-blind phase to LAQ/5063 OL. - Use of amiodarone in\r<br> the period from termination of LAQ/5063 active double-blind phase to LAQ/5063 OL. -\r<br> Following the switch to new formulation (capsules), hypersensitivity to mannitol,\r<br> meglumine, or sodium stearyl fumarate.\r<br>", "exclusion_criteria": null, "condition": "Relapsing Remitting Multiple Sclerosis", "intervention": "Drug: Laquinimod;Drug: Placebo", "primary_outcome": "Double-Blind Extension Period: Number of Participants With Adverse Events (AEs);Open-label Extension Period: Number of Participants With AEs;Double-Blind Period: Number of Participants Who Prematurely Discontinued From the Study Due to Any Reason and Due to AEs;Open-Label Period: Number of Participants Who Prematurely Discontinued From the Study Due to Any Reason and Due to AEs", "secondary_outcome": "Double-Blind Period: Relapse Rate: Total Number of Confirmed Relapses;Double-Blind Period: Percentage of Relapse-Free Participants;Double-Blind Period: Number of Enhancing Lesions on T1-Weighted Images;Double-Blind Period: Number of New T2 Lesions;Double-Blind Period: Volume of T2 Lesions;Double-Blind Period: Number of New Hypointense T1 Lesion on Enhanced T1 Scans;Double-Blind Period: Kurtzke's Expanded Disability Status Scale (EDSS) Score", "secondary_id": "LAQ/5063;2005-004334-41;LAQ/5063OL", "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": 3625, "title": "Magnetic Resonance Imaging (MRI) Follow-up of Macrophagic Infiltration in MS Patients Treated With Tysabri", "summary": null, "published_date": "2008-11-09T00:00:00Z", "discovery_date": "2023-12-06T18:18:21.515365Z", "link": "http://clinicaltrials.gov/show/NCT00752778", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT00752778" }, "categories": [ { "category_id": 7, "category_description": "", "category_name": "Natalizumab", "category_slug": "natalizumab", "category_terms": [ "natalizumab", "tysabri" ], "article_count": 298 } ], "export_date": "2024-04-19T00:00:00Z", "internal_number": "4647107", "last_refreshed_on": "2015-02-19", "scientific_title": "MRI Follow-up of Macrophagic Infiltration in MS Patients Treated With Tysabri", "primary_sponsor": "University Hospital, Strasbourg, France", "retrospective_flag": "Yes", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Not recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "65 Years", "inclusion_gender": "Both", "date_enrollement": "2008-12-19", "target_size": "8", "study_type": "Interventional", "study_design": "Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment", "phase": "Phase 4", "countries": "France", "contact_firstname": "", "contact_lastname": "Jérôme DE SEZE, MD", "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": "Hôpitaux universitaires de Strasbourg", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - Patients diagnosed with MS\r<br>\r<br> - Treatment with Tysabri planned\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Allergy to Tysabri or MRI contrast products\r<br>\r<br> - Pregnancy\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis", "intervention": "Other: pet-scan FDG-F18", "primary_outcome": "Number of enhanced lesions on MRI before and after treatment. PET scan modification in brain (in enhanced lesions and in the whole brain).", "secondary_outcome": "Correlation with relapses.", "secondary_id": "4118", "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": 3624, "title": "A prospective, multicentre, open label, exploratory study to investigate the ability of the Heidelberg Assay Panel and the B-Cell /Antibody response panel to predict the clinical effect of Octagam 5% in subjects with relapsing/remitting (RR) multiple sclerosis (MS)", "summary": null, "published_date": "2008-09-15T00:00:00Z", "discovery_date": "2023-12-06T18:18:21.495540Z", "link": "https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-004579-22", "source": "WHO XML import", "relevant": null, "identifiers": { "euctr": "EUCTR2008-004579-22-AT" }, "categories": [], "export_date": "2024-04-19T00:00:00Z", "internal_number": "2468667", "last_refreshed_on": "2012-03-19", "scientific_title": "A prospective, multicentre, open label, exploratory study to investigate the ability of the Heidelberg Assay Panel and the B-Cell /Antibody response panel to predict the clinical effect of Octagam 5% in subjects with relapsing/remitting (RR) multiple sclerosis (MS)", "primary_sponsor": "Octapharma 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": "2008-10-14", "target_size": "30", "study_type": "Interventional clinical trial of medicinal product", "study_design": "Controlled: no\nRandomised: no\nOpen: no\nSingle blind: no\nDouble blind: no\nParallel group: no\nCross over: no\nOther: no\nIf controlled, specify comparator, Other Medicinial Product: no\nPlacebo: no\nOther: no", "phase": null, "countries": "Austria", "contact_firstname": null, "contact_lastname": null, "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": null, "inclusion_criteria": "Inclusion criteria: <br>·Subjects aged = 18 years.<br>MS according to the revised McDonald criteria.<br>Relapsing-remitting form of MS.<br>First-line disease modifying treatments (IFN-beta or glatiramer acetate) are contraindicated or not tolerated.<br>Kurtzke’s EDSS between 0 and 3.5 (0 to <= 3.5).<br>Subjects who experienced at least one relapse during the last 12 months or at least two relapses in the last 24 months prior to study entry.<br>Freely given, fully informed written consent obtained from subject.<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) yes<br>F.1.3.1 Number of subjects for this age range <br>", "exclusion_criteria": "Exclusion criteria: <br>Subjects who have received treatment with immunoglobulins for any reason previously.<br>Subjects who have received immuno-suppressive treatments (e.g. azathioprine, mitoxantrone, cyclophosphamide) for any reason previously except relapse treatment with corticosteroids.\t<br>Subjects who have received disease modifying first-line treatments treatment with IFN-beta during the last 8 weeks or with glatiramer acetate during the last 16 weeks.<br>Subjects who have received any monoclonal antibody therapies (e.g. natalizumab) previously.\t<br>Subjects who had a relapse within 3 months prior to study entry.\t<br>Subjects with severe renal function impairment as defined by serum creatinine values > 24 mg/L.\t<br>Subjects with known intolerance to homologous immunoglobulins, especially immunoglobulin A (IgA) deficiency, when the subject has antibodies against IgA.<br>Subjects with a body weight of >120 kg.<br>Subjects with a history of anaphylaxis after previous transfusions of blood or blood products.<br>Subjects for whom MRI is contraindicated or who are allergic to gadolinium. Pregnant or lactating women.\t<br>Subjects who delivered a baby within 12 months before study entry (including miscarriage and stillbirth).\t<br>Subjects with a diagnosis of significant depression.\t<br>Subjects with known chronic infectious diseases or malignant disease.·\tSubjects with known antibody deficiencies or other autoimmune diseases other than MS.Subjects participating in another study during the course of this study or during the past 6 months or who have ever participated in a study investigating in new disease modifying or immunosuppressive drugs. <br>", "condition": "Subjects with RR Multiple Sclerosis in whom intravenous immunoglobulin (IVIG) treatment is clinically indicated because first-line treatments are contraindicated or not tolerated.", "intervention": "<br>Trade Name: Octagam 5%<br>Product Name: Octagam 5%<br>Pharmaceutical Form: Intravenous infusion<br>INN or Proposed INN: Immunoglobulin<br>CAS Number: 9007-83-4<br>Concentration unit: % percent<br>Concentration type: equal<br>Concentration number: 5-<br><br>", "primary_outcome": "Secondary Objective: ;Primary end point(s): Heidelberg Assay Panel<br>B-cell Antibody Response Panel<br>Clinical Response: Relapse Activity, Disability Assessment;Main Objective: To investigate whether any parameters of the HAP correlate with the clinical effect observed following Octagam 5% treatment in subjects with RR MS.\t<br>To investigate whether any B-cell/antibody responses correlate with the clinical effect observed following Octagam 5% treatment in subjects with RR MS.\t<br>To investigate the proportion of subjects responding to Octagam 5% treatment vs. subjects not responding.<br>To investigate the relapse activity during the observation period.<br>To investigate efficacy as assessed by neurological examinations using the Expanded Disability Status Scale (EDSS) and Functional System (FS) and the Multiple Sclerosis Functional Composite measure (MSFC).<br>To investigate the change of T2/T1 lesion load and active lesions as demonstrated by contrast enhancement on magnetic resonance imaging (MRI).<br>To investigate the tolerability of Octagam 5% in subjects with RR MS by monitoring safety parameters (vital signs, adverse events (AEs), safety laboratory tests).", "secondary_outcome": null, "secondary_id": "GAM-25", "source_support": null, "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": 3623, "title": "American Ginseng Treatment for Multiple Sclerosis Related Fatigue", "summary": null, "published_date": "2008-09-16T00:00:00Z", "discovery_date": "2023-12-06T18:18:21.474985Z", "link": "https://clinicaltrials.gov/show/NCT00754832", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT00754832" }, "categories": [], "export_date": "2024-04-19T00:00:00Z", "internal_number": "6491452", "last_refreshed_on": "2017-10-19", "scientific_title": "A Double-blinded, Placebo-controlled Crossover Pilot Study of American Ginseng Treatment for Multiple Sclerosis Related Fatigue", "primary_sponsor": "Oregon Health and Science University", "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": "2005-09-19", "target_size": "56", "study_type": "Interventional", "study_design": null, "phase": "Phase 2", "countries": "United States;United States;United States;United States", "contact_firstname": "; ; ;", "contact_lastname": "Ruth Whitham, M.D.;Ruth Whitham, M.D.;Ruth Whitham, M.D.;Ruth Whitham, M.D.", "contact_address": null, "contact_email": ";;;", "contact_tel": ";;;", "contact_affiliation": "Oregon Health and Science University;Oregon Health and Science University;Oregon Health and Science University;Oregon Health and Science University", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - MS as diagnosed by the McDonald criteria\r<br>\r<br> - Complaint of fatigue that has been persistent for at least 2 months\r<br>\r<br> - FSS score of 4 or greater;\r<br>\r<br> - Age 18-70.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Use of ginseng or stimulants in the prior 6 weeks\r<br>\r<br> - Acute treatment with glucocorticoids in the prior 6 weeks\r<br>\r<br> - BDI >31\r<br>\r<br> - Significant MS exacerbation in prior 30 days\r<br>\r<br> - Diabetes\r<br>\r<br> - Uncontrolled hypertension\r<br>\r<br> - Other serious medical disease, pregnancy or breastfeeding\r<br>\r<br> - Breast disease\r<br>\r<br> - Abnormal bleeding or clotting disorder\r<br>\r<br> - Current use of warfarin, albendazole, nifedipine, digoxin, bumetadine, selegiline,\r<br> isocarboxazid, or phenelzine\r<br>\r<br> - Current use of lasix for poorly controlled hypertension or congestive heart failure\r<br>\r<br> - Current drug or alcohol abuse; inability to complete the self report forms\r<br> ;\r<br> Inclusion Criteria:\r<br>\r<br> - MS as diagnosed by the McDonald criteria\r<br>\r<br> - Complaint of fatigue that has been persistent for at least 2 months\r<br>\r<br> - FSS score of 4 or greater;\r<br>\r<br> - Age 18-70.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Use of ginseng or stimulants in the prior 6 weeks\r<br>\r<br> - Acute treatment with glucocorticoids in the prior 6 weeks\r<br>\r<br> - BDI >31\r<br>\r<br> - Significant MS exacerbation in prior 30 days\r<br>\r<br> - Diabetes\r<br>\r<br> - Uncontrolled hypertension\r<br>\r<br> - Other serious medical disease, pregnancy or breastfeeding\r<br>\r<br> - Breast disease\r<br>\r<br> - Abnormal bleeding or clotting disorder\r<br>\r<br> - Current use of warfarin, albendazole, nifedipine, digoxin, bumetadine, selegiline,\r<br> isocarboxazid, or phenelzine\r<br>\r<br> - Current use of lasix for poorly controlled hypertension or congestive heart failure\r<br>\r<br> - Current drug or alcohol abuse; inability to complete the self report forms\r<br> ;\r<br> Inclusion Criteria:\r<br>\r<br> - MS as diagnosed by the McDonald criteria\r<br>\r<br> - Complaint of fatigue that has been persistent for at least 2 months\r<br>\r<br> - FSS score of 4 or greater;\r<br>\r<br> - Age 18-70.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Use of ginseng or stimulants in the prior 6 weeks\r<br>\r<br> - Acute treatment with glucocorticoids in the prior 6 weeks\r<br>\r<br> - BDI >31\r<br>\r<br> - Significant MS exacerbation in prior 30 days\r<br>\r<br> - Diabetes\r<br>\r<br> - Uncontrolled hypertension\r<br>\r<br> - Other serious medical disease, pregnancy or breastfeeding\r<br>\r<br> - Breast disease\r<br>\r<br> - Abnormal bleeding or clotting disorder\r<br>\r<br> - Current use of warfarin, albendazole, nifedipine, digoxin, bumetadine, selegiline,\r<br> isocarboxazid, or phenelzine\r<br>\r<br> - Current use of lasix for poorly controlled hypertension or congestive heart failure\r<br>\r<br> - Current drug or alcohol abuse; inability to complete the self report forms\r<br> ;\r<br> Inclusion Criteria:\r<br>\r<br> - MS as diagnosed by the McDonald criteria\r<br>\r<br> - Complaint of fatigue that has been persistent for at least 2 months\r<br>\r<br> - FSS score of 4 or greater;\r<br>\r<br> - Age 18-70.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Use of ginseng or stimulants in the prior 6 weeks\r<br>\r<br> - Acute treatment with glucocorticoids in the prior 6 weeks\r<br>\r<br> - BDI >31\r<br>\r<br> - Significant MS exacerbation in prior 30 days\r<br>\r<br> - Diabetes\r<br>\r<br> - Uncontrolled hypertension\r<br>\r<br> - Other serious medical disease, pregnancy or breastfeeding\r<br>\r<br> - Breast disease\r<br>\r<br> - Abnormal bleeding or clotting disorder\r<br>\r<br> - Current use of warfarin, albendazole, nifedipine, digoxin, bumetadine, selegiline,\r<br> isocarboxazid, or phenelzine\r<br>\r<br> - Current use of lasix for poorly controlled hypertension or congestive heart failure\r<br>\r<br> - Current drug or alcohol abuse; inability to complete the self report forms\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis;Multiple Sclerosis;Multiple Sclerosis;Multiple Sclerosis", "intervention": "Drug: American ginseng extract HT-1001;Drug: placebo;Drug: American ginseng extract HT-1001;Drug: placebo;Drug: American ginseng extract HT-1001;Drug: placebo;Drug: American ginseng extract HT-1001;Drug: placebo", "primary_outcome": "Fatigue Severity Scale;Fatigue Severity Scale", "secondary_outcome": "Modified Fatigue Impact Scale;Realtime Digital Fatigue Score", "secondary_id": "1357", "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": 3622, "title": "Duloxetine for Multiple Sclerosis Pain", "summary": null, "published_date": "2008-09-17T00:00:00Z", "discovery_date": "2023-12-06T18:18:21.452240Z", "link": "https://clinicaltrials.gov/show/NCT00755807", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT00755807" }, "categories": [], "export_date": "2024-04-19T00:00:00Z", "internal_number": "6491466", "last_refreshed_on": "2017-10-19", "scientific_title": "Duloxetine in Patients With Central Neuropathic Pain Due to Multiple Sclerosis.", "primary_sponsor": "Eli Lilly and Company", "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": "All", "date_enrollement": "2008-10-19", "target_size": "239", "study_type": "Interventional", "study_design": null, "phase": "Phase 3", "countries": "United States;Belgium;Canada;Poland;Belgium;Canada;Poland;United States;United States;Belgium;Canada;Poland;Belgium;Canada;Poland;United States;United States;Belgium;Canada;Poland;Belgium;Canada;Poland;United States;United States;Belgium;Canada;Poland;Belgium;Canada;Poland;United States", "contact_firstname": "; ; ;", "contact_lastname": "Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 Hours, EST);Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 Hours, EST);Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 Hours, EST);Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 Hours, EST)", "contact_address": null, "contact_email": ";;;", "contact_tel": ";;;", "contact_affiliation": "Eli Lilly and Company;Eli Lilly and Company;Eli Lilly and Company;Eli Lilly and Company", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - Have central neuropathic pain due to multiple sclerosis (MS) based on the disease\r<br> diagnostic criteria\r<br>\r<br> - Adult males or females\r<br>\r<br> - Have a score of 4 or greater on the daily 24-hour average pain score\r<br>\r<br> - Females must test negative for pregnancy at study entry\r<br>\r<br> - Complete the daily diaries for at least 70% of the days of the study\r<br>\r<br> - Participants may continue other prescription and nonprescription analgesic pain\r<br> medications as long as the dose has been stable for 1 month prior to study entry, and\r<br> they agree to maintain that stable dose throughout the study Disease Diagnostic\r<br> Criteria:\r<br>\r<br> - Diagnosis of MS at least 1 year prior to study entry\r<br>\r<br> - No MS flares or change in disease treatment for the 3 months prior to study entry\r<br>\r<br> - Daily pain due to MS for a minimum of 3 months prior to study entry\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Are currently in a clinical trial of MS disease-modifying therapy\r<br>\r<br> - Have pain that cannot be clearly differentiated from causes other than MS\r<br>\r<br> - Any current or historical diagnosis of mania, bipolar disorder, psychosis, or\r<br> schizoaffective disorder\r<br>\r<br> - History of substance abuse or dependence\r<br>\r<br> - Are pregnant or breast-feeding\r<br> ;\r<br> Inclusion Criteria:\r<br>\r<br> - Have central neuropathic pain due to multiple sclerosis (MS) based on the disease\r<br> diagnostic criteria\r<br>\r<br> - Adult males or females\r<br>\r<br> - Have a score of 4 or greater on the daily 24-hour average pain score\r<br>\r<br> - Females must test negative for pregnancy at study entry\r<br>\r<br> - Complete the daily diaries for at least 70% of the days of the study\r<br>\r<br> - Participants may continue other prescription and nonprescription analgesic pain\r<br> medications as long as the dose has been stable for 1 month prior to study entry, and\r<br> they agree to maintain that stable dose throughout the study Disease Diagnostic\r<br> Criteria:\r<br>\r<br> - Diagnosis of MS at least 1 year prior to study entry\r<br>\r<br> - No MS flares or change in disease treatment for the 3 months prior to study entry\r<br>\r<br> - Daily pain due to MS for a minimum of 3 months prior to study entry\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Are currently in a clinical trial of MS disease-modifying therapy\r<br>\r<br> - Have pain that cannot be clearly differentiated from causes other than MS\r<br>\r<br> - Any current or historical diagnosis of mania, bipolar disorder, psychosis, or\r<br> schizoaffective disorder\r<br>\r<br> - History of substance abuse or dependence\r<br>\r<br> - Are pregnant or breast-feeding\r<br> ;\r<br> Inclusion Criteria:\r<br>\r<br> - Have central neuropathic pain due to multiple sclerosis (MS) based on the disease\r<br> diagnostic criteria\r<br>\r<br> - Adult males or females\r<br>\r<br> - Have a score of 4 or greater on the daily 24-hour average pain score\r<br>\r<br> - Females must test negative for pregnancy at study entry\r<br>\r<br> - Complete the daily diaries for at least 70% of the days of the study\r<br>\r<br> - Participants may continue other prescription and nonprescription analgesic pain\r<br> medications as long as the dose has been stable for 1 month prior to study entry, and\r<br> they agree to maintain that stable dose throughout the study Disease Diagnostic\r<br> Criteria:\r<br>\r<br> - Diagnosis of MS at least 1 year prior to study entry\r<br>\r<br> - No MS flares or change in disease treatment for the 3 months prior to study entry\r<br>\r<br> - Daily pain due to MS for a minimum of 3 months prior to study entry\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Are currently in a clinical trial of MS disease-modifying therapy\r<br>\r<br> - Have pain that cannot be clearly differentiated from causes other than MS\r<br>\r<br> - Any current or historical diagnosis of mania, bipolar disorder, psychosis, or\r<br> schizoaffective disorder\r<br>\r<br> - History of substance abuse or dependence\r<br>\r<br> - Are pregnant or breast-feeding\r<br> ;\r<br> Inclusion Criteria:\r<br>\r<br> - Have central neuropathic pain due to multiple sclerosis (MS) based on the disease\r<br> diagnostic criteria\r<br>\r<br> - Adult males or females\r<br>\r<br> - Have a score of 4 or greater on the daily 24-hour average pain score\r<br>\r<br> - Females must test negative for pregnancy at study entry\r<br>\r<br> - Complete the daily diaries for at least 70% of the days of the study\r<br>\r<br> - Participants may continue other prescription and nonprescription analgesic pain\r<br> medications as long as the dose has been stable for 1 month prior to study entry, and\r<br> they agree to maintain that stable dose throughout the study Disease Diagnostic\r<br> Criteria:\r<br>\r<br> - Diagnosis of MS at least 1 year prior to study entry\r<br>\r<br> - No MS flares or change in disease treatment for the 3 months prior to study entry\r<br>\r<br> - Daily pain due to MS for a minimum of 3 months prior to study entry\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Are currently in a clinical trial of MS disease-modifying therapy\r<br>\r<br> - Have pain that cannot be clearly differentiated from causes other than MS\r<br>\r<br> - Any current or historical diagnosis of mania, bipolar disorder, psychosis, or\r<br> schizoaffective disorder\r<br>\r<br> - History of substance abuse or dependence\r<br>\r<br> - Are pregnant or breast-feeding\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis;Multiple Sclerosis;Multiple Sclerosis;Multiple Sclerosis", "intervention": "Drug: Duloxetine Hydrochloride (HCI);Drug: Placebo;Drug: Duloxetine Hydrochloride (HCI);Drug: Placebo;Drug: Duloxetine Hydrochloride (HCI);Drug: Placebo;Drug: Duloxetine Hydrochloride (HCI);Drug: Placebo", "primary_outcome": "Change From Baseline in the Weekly 24-Hour Average Pain Scores at Week 6 (Acute Phase);Change From Baseline in the Weekly 24-Hour Average Pain Scores at Week 6 (Acute Phase)", "secondary_outcome": "Change From Baseline in the Weekly 24-Hour Average Pain Scores up to Week 6 (Acute Phase);Patient Global Impressions of Improvement Scale (PGI-I) at 6 Weeks;Change From Baseline in the Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) at Week 6 (Acute Phase);Change From Baseline in the Clinical Global Impression of Severity Scale (CGI-S) at 6 Weeks (Acute Phase);Change From Baseline in the Multiple Sclerosis Quality of Life-54 Instrument (MS-QOL-54) at 6 Weeks (Acute Phase);Number of Participants With Suicidal Behaviors, Ideations, and Acts Based on The Columbia Suicide Severity Rating Scale (C-SSRS) at Week 6;Change From Baseline in the Weekly Mean of Night Pain Scores at Week 6 (Acute Phase);Change From Baseline in the Beck Depression Inventory II (BDI-II) Question #9 at Week 6 (Acute Phase);Number of Participants Who Discontinued During the Acute Phase (by Week 6);Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Acute Phase;Number of Participants With Adverse Events (AEs) Resulting in Discontinuation From Baseline During the Acute Phase;Change From Baseline in Blood Pressure at Week 6 (Acute Phase);Change From Baseline in Pulse Rate at Week 6 (Acute Phase);Change From Baseline in Weight at Week 6 (Acute Phase);Patient Global Impressions of Improvement Scale (PGI-I) Score at 18 Weeks;Change From Baseline in Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) at Week 18;Change From Baseline in the Clinical Global Impression of Severity Scale (CGI-S) Score at Week 18 (Open-label Extension Phase);Change From Baseline in Multiple Sclerosis Quality of Life-54 Instrument (MS-QOL-54) at Week 18 (Open-label Extension Phase);Number of Participants With Suicidal Behaviors, Ideations, and Acts Based on The Columbia Suicide Severity Rating Scale (C-SSRS) at Week 18;Change in the Weekly Mean of the Night Pain Scores From Week 6 Through Week 18 (Open-label Extension Phase);Change From Baseline in Beck Depression Inventory II (BDI-II), Question #9 at Week 18 (Open-label Extension Phase);Number of Participants Who Discontinued During the Open-label Extension Phase (by Week 18);Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Open-label Extension Phase;Number of Participants With Adverse Events (AEs) Resulting in Discontinuation During the Open-label Extension Phase;Change From Baseline in Blood Pressure at Week 18 (Open-label Extension Phase);Change From Baseline in Pulse Rate at Week 18 (Open-label Extension Phase);Change From Baseline in Weight at Week 18 (Open-label Extension Phase)", "secondary_id": "F1J-US-HMFR;11666", "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": 3621, "title": "Chronotherapy in Acute Multiple Sclerosis (MS) Attack", "summary": null, "published_date": "2008-01-10T00:00:00Z", "discovery_date": "2023-12-06T18:18:21.431447Z", "link": "http://clinicaltrials.gov/show/NCT00764413", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT00764413" }, "categories": [], "export_date": "2024-04-19T00:00:00Z", "internal_number": "4647991", "last_refreshed_on": "2015-02-19", "scientific_title": "Treatment With Methylprednisolone in Acute Exacerbations of Multiple Sclerosis: Enhanced Effect With Nighttime Treatment?", "primary_sponsor": "Sykehuset Innlandet HF", "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": "2009-04-19", "target_size": "57", "study_type": "Interventional", "study_design": "Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment", "phase": "N/A", "countries": "Norway", "contact_firstname": "; ; ; ;", "contact_lastname": "Anette H Farmen, Physician/MD;Kristin I Løken-Amsrud, Physician/MD;Elisabeth G Celius, MD/PhD;Per O Vandvik, MD/PhD;Trygve Holmøy, MD/PhD", "contact_address": null, "contact_email": ";;;;", "contact_tel": ";;;;", "contact_affiliation": "Innlandet Hospital Trust Lillehammer, Neurological Department;Innlandet Hospital Trust Lillehammer, Neurological Department;Oslo University Hospital, Ullevål, Neurological Department;Innlandet Hospital Trust Gjøvik, Department of Internal medicin;Oslo University Hospital, Ullevål, Neurological department", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - Relapsing remitting MS\r<br>\r<br> - EDSS-score before the actual attack < 6.0\r<br>\r<br> - Acute MS-attack with indication for treatment with steroids\r<br>\r<br> - Symptoms >24 hours < 4 weeks\r<br>\r<br> - Age 18 years or older\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Prior enrollment in this study\r<br>\r<br> - Ongoing serious infection that is a contraindication for treatment with steroids\r<br>\r<br> - Pregnancy\r<br>\r<br> - Medical situations (prior acute diseases) where treatment with intravenous steroids\r<br> over short period of time is contraindicated or not favorable.\r<br>\r<br> - Enhanced cognitive dysfunction\r<br>\r<br> - Treatment with p.o or i.v steroids within 3 weeks prior to date of inclusion\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis", "intervention": "Drug: methylprednisolone;Drug: Sodium chlorid", "primary_outcome": "The difference in mean changes in EDSS-score between the group receiving treatment during the night opposed to during the day.", "secondary_outcome": "The difference in MSFC-score in the two groups;Side effect registered by the patient;The patient`s quality of life;MRI - volume and number for MS-lesions, Gd-enhancement;Fatigue;Depression", "secondary_id": "150134;2008-002025-37;15002", "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": 3620, "title": "Lokomat Training Effects on MS Gait Abnormalities", "summary": null, "published_date": "2008-02-10T00:00:00Z", "discovery_date": "2023-12-06T18:18:21.410266Z", "link": "http://clinicaltrials.gov/show/NCT00766272", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT00766272" }, "categories": [], "export_date": "2024-04-19T00:00:00Z", "internal_number": "4648134", "last_refreshed_on": "2015-02-19", "scientific_title": "Gait Rehabilitation for Multiple Sclerosis Using Robot-assisted Body-weight-supported Treadmill Training (Lokomat)", "primary_sponsor": "Department of Veterans Affairs", "retrospective_flag": "No", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Not recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "75 Years", "inclusion_gender": "Both", "date_enrollement": "2008-06-19", "target_size": "20", "study_type": "Interventional", "study_design": "Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment", "phase": "Phase 1/Phase 2", "countries": "United States", "contact_firstname": "", "contact_lastname": "Albert Lo, MD PhD", "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": "Providence VA Medical Center", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> 1. Diagnosis of MS by McDonald criteria\r<br>\r<br> 2. Ability to clearly understand written and oral direction in English\r<br>\r<br> 3. Self-reported gait problem\r<br>\r<br> 4. One or more falls in the past 6 months\r<br>\r<br> 5. The ability to walk 25 feet with no more than a cane for assistance (The subject must\r<br> be comfortable using a cane)\r<br>\r<br> 6. Age 18-70\r<br>\r<br> 7. Written informed consent to participate in the study\r<br>\r<br> 8. Approval from subject's primary care physician for physical activity\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> 1. No relapse within the last 3 months\r<br>\r<br> 2. No more than two relapses within the past 12 months\r<br>\r<br> 3. Recent myocardial infarction\r<br>\r<br> 4. Uncontrolled hypertension or diabetes\r<br>\r<br> 5. Symptomatic fall in blood pressure when standing\r<br>\r<br> 6. Vascular claudication or pitting edema\r<br>\r<br> 7. Cognitive impairments that limit comprehension of protocol instructions (assessed by\r<br> Comprehension Test of Consent Form)\r<br>\r<br> 8. Body weight over 150 kg\r<br>\r<br> 9. FES-I < 25\r<br>\r<br> 10. Lower extremity injuries that limit range of motion or function\r<br>\r<br> 11. Joint problems (hip or leg) that limit range of motion or cause pain with movement\r<br>\r<br> 12. Unstable fractures\r<br>\r<br> 13. Pressure sores with any skin breakdown in areas in contact with the body harness or\r<br> the robot-driven gait orthotic apparatus\r<br>\r<br> 14. Currently enrolled in an alcohol or drug treatment program\r<br>\r<br> 15. A complicating medical condition that would prevent completion of the trial\r<br>\r<br> 16. Enrolled in or planning to enroll in another interventional research trial using\r<br> procedures proposed to enhance or limit the function of the upper or lower\r<br> extremities (such as adjuvant rehabilitation or Botox injections) during the 24 weeks\r<br> of participation\r<br>\r<br> 17. A difference of more than 2cm between subjects' right and left leg lengths\r<br>\r<br> 18. Unable to be properly fit into the harness or Lokomat device\r<br>\r<br> 19. Hypertonicity or spasticity that it interferes with a proper fit into the Lokomat\r<br>\r<br> 20. Pregnancy at enrollment, as determined by a home pregnancy test kit at screening\r<br> visit\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis", "intervention": "Device: Lokomat", "primary_outcome": "Frequency of Falls", "secondary_outcome": null, "secondary_id": "LO-0003", "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": 3619, "title": "Targeted Lower Extremity Joint Training", "summary": null, "published_date": "2008-02-10T00:00:00Z", "discovery_date": "2023-12-06T18:18:21.385311Z", "link": "http://clinicaltrials.gov/show/NCT00765544", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT00765544" }, "categories": [], "export_date": "2024-04-19T00:00:00Z", "internal_number": "4648078", "last_refreshed_on": "2015-02-19", "scientific_title": "Robot-assisted Ankle Rehabilitation for Multiple Sclerosis (Anklebot)", "primary_sponsor": "Department of Veterans Affairs", "retrospective_flag": "No", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Not recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "75 Years", "inclusion_gender": "Both", "date_enrollement": "2008-09-19", "target_size": "10", "study_type": "Interventional", "study_design": "Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment", "phase": "Phase 1/Phase 2", "countries": "United States", "contact_firstname": "", "contact_lastname": "Albert Lo, MD PhD", "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": "Providence VA Medical Center", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> 1. Clinical diagnosis of MS by McDonald criteria (McDonald, Compston et al. 2001). EDSS\r<br> level between 3.5-5.5, who report ambulation problems.\r<br>\r<br> 2. Men and women between the ages 18-75 years.\r<br>\r<br> 3. Presence of unilateral foot drop that is clinically apparent to the PI or PI\r<br> designate.\r<br>\r<br> 4. Must be able to ambulate 25 feet without an assisting device\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> 1. Cardiovascular: recent MI < 4 wk, uncontrolled HTN >190/110 mmHg, History of\r<br> uncontrolled diabetes.\r<br>\r<br> 2. Symptoms of orthostasis when standing up.\r<br>\r<br> 3. Circulatory problems, history of vascular claudication or pitting edema.\r<br>\r<br> 4. Unable to fully understand instructions in order to use the equipment or the process\r<br> of the study.\r<br>\r<br> 5. Body weight over 150 kg.\r<br>\r<br> 6. Lower extremity injuries that limit range of motion or function.\r<br>\r<br> 7. Joint problems (hip or leg) that limit range of motion or cause pain with movement\r<br> despite treatment.\r<br>\r<br> 8. Unstable fractures.\r<br>\r<br> 9. Pressure sores with any skin breakdown in areas in contact with the body harness or\r<br> Lokomat apparatus.\r<br>\r<br> 10. Chronic and ongoing alcohol or drug abuse.\r<br>\r<br> 11. Pre-morbid, ongoing depression or psychosis.\r<br>\r<br> 12. Ongoing physical therapy.\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis", "intervention": "Device: Anklebot;Device: Lokomat", "primary_outcome": "Strength and Gait", "secondary_outcome": null, "secondary_id": "LO-0002", "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": 3618, "title": "A Long-Term Open Label Extension Study to assess the Safety, Tolerability, and Efficacy of Neramexane Mesylate in Congenital Idiopathic Nystagmus and Acquired Nystagmus.", "summary": null, "published_date": "2008-03-10T00:00:00Z", "discovery_date": "2023-12-06T18:18:21.360074Z", "link": "https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-007663-25", "source": "WHO XML import", "relevant": null, "identifiers": { "euctr": "EUCTR2007-007663-25-GB" }, "categories": [], "export_date": "2024-04-19T00:00:00Z", "internal_number": "8616660", "last_refreshed_on": "2019-12-10", "scientific_title": "A Long-Term Open Label Extension Study to assess the Safety, Tolerability, and Efficacy of Neramexane Mesylate in Congenital Idiopathic Nystagmus and Acquired Nystagmus.", "primary_sponsor": "Merz Pharmaceuticals GmbH", "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": "2008-11-17", "target_size": "48", "study_type": "Interventional clinical trial of medicinal product", "study_design": "<br> Controlled: no<br> Randomised: no<br> Open: yes<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\n Therapeutic exploratory (Phase II): yes\n Therapeutic confirmatory - (Phase III): no\n Therapeutic use (Phase IV): no", "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> •\tMale or female patients between 18 and 81 years (inclusive) of age who have successfully completed both study periods in the previous double-blind protocol MRZ 92579 0707/1 and who have been deemed eligible (had a response to treatment) in the judgment of the Investigator;<br> •\tPatient fulfilled, at entry into the double-blind study, the diagnostic criteria for congenital idiopathic nystagmus (CIN) or nystagmus secondary to multiple sclerosis (MS);<br> •\tPatient has been properly informed of the nature and risks of the study and has given written informed consent prior to entering the study;<br> •\t12 lead electrocardiogram (ECG) without clinically significant abnormalities at baseline;<br> •\tAble and willing to comply with instructions during the outpatient periods;<br> •\tFor females of childbearing potential (last menses less than one year prior to enrolment): negative pregnancy test at baseline (i.e. prior to entry in the double-blind treatment phase); not breast-feeding; either surgically sterile or agreement to use a medically accepted, highly effective contraception during the entire duration of the study.<br> Multiple sclerosis patients only:<br> •\t‘multiple sclerosis’ patients must be neurologically stable with no evidence of acute relapse.<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) yes<br> F.1.3.1 Number of subjects for this age range<br>", "exclusion_criteria": "Exclusion criteria: <br> •\tOccurrence of any major treatment-emergent adverse event or condition during the previous protocol (MRZ 92579 0707/1) that, in the opinion of the Investigator, should exclude the patient from participating in the open label extension;<br> •\tPatients with a clinically significant medical or surgical condition at baseline which might compromise the hematologic, cardiovascular, pulmonary, renal, gastrointestinal, or hepatic system or other conditions / abnormalities of sufficient severity that would preclude safe enrollment in the study or interfere with their participation in the study (e.g. psychiatric disorder);<br> •\tPatients with arterial hypertension (systolic blood pressure greater than 180 mmHg or less than 90 mmHg), or hypotension (diastolic blood pressure greater than 105 mmHg or less than 50 mmHg) at baseline;<br> •\tPatients with known hypersensitivity or intolerance to neramexane, amantadine, or memantine;<br> •\tPatients with known or suspected alcoholism or drug abuse<br> •\tPatients requiring concomitant treatment with any prohibited prescription or over-the-counter medication (Appendix 11.1);<br> •\tRelevant non-compliance issue(s) in the previous protocol or a history of chronic non-compliance with drug regimens;<br> •\tPatients who, in the judgment of the Investigator, might not be suitable for enrollment into the study.<br> Multiple sclerosis patients only:<br><br>", "condition": "congenital idiopathic nystagmus and aquired nystagmus <br>\n MedDRA version: 9.1\n Level: LLT\n Classification code 10029864\n Term: Nystagmus\n <br>\n MedDRA version: 9.1\n Level: LLT\n Classification code 10029867\n Term: Nystagmus congenital", "intervention": "<br> Product Name: Neramexane mesylate MR film-coated tablet 25 mg<br> Pharmaceutical Form: Modified-release tablet<br> INN or Proposed INN: Neramexane Mesylate<br> CAS Number: 457068-92-7<br> Other descriptive name: 1-Amino-1,3,3,5,5-Pentamethylcyclohexane-Mesylate<br> Concentration unit: mg milligram(s)<br> Concentration type: equal<br> Concentration number: 25-<br><br>", "primary_outcome": "Main Objective: The main purpose of the study is to evaluate the long-term safety and tolerability of daily doses of 25, 50, or 75 mg neramexane mesylate in the treatment of congenital idiopathic nystagmus or nystagmus secondary to multiple sclerosis. The study will also investigate the permanence of visual acuity improvement (long-term efficacy).;Secondary Objective: ;Primary end point(s): The primary objective of this open-label, extension study is to evaluate the long-term safety and tolerability of daily doses of 25, 50, or 75 mg neramexane mesylate in the treatment of CIN or nystagmus secondary to multiple sclerosis. A further objective of the trial will be to investigate the permanence of visual acuity improvement.", "secondary_outcome": null, "secondary_id": "MRZ 92579-0738/1", "source_support": null, "ethics_review_status": "Approved", "ethics_review_approval_date": "1900-01-01", "ethics_review_contact_name": null, "ethics_review_contact_address": null, "ethics_review_contact_phone": null, "ethics_review_contact_email": null, "results_date_completed": "2010-10-06", "results_url_link": null }, { "trial_id": 3617, "title": "Cognitive behavioural therapy software for the treatment of depression in people with multiple sclerosis", "summary": null, "published_date": "2008-06-10T00:00:00Z", "discovery_date": "2023-12-06T18:18:21.340034Z", "link": "http://isrctn.com/ISRCTN81846800", "source": "WHO XML import", "relevant": null, "identifiers": { "isrctn": "ISRCTN81846800" }, "categories": [], "export_date": "2024-04-19T00:00:00Z", "internal_number": "9065142", "last_refreshed_on": "2020-04-06", "scientific_title": "Computerised cognitive behavioural therapy for treatment of depression in multiple sclerosis (MS) (CoSMoS): Clinical trial pilot study", "primary_sponsor": "University of Sheffield (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": "2008-01-09", "target_size": "24", "study_type": "Interventional", "study_design": "Parallel group randomised pilot trial (Treatment)", "phase": "Not Specified", "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> 1. Aged 18+, both males and females<br> 2. Diagnosis of MS confirmed by neurologist<br> 3. Beck Depression Inventory-II score of at least 14 on two consecutive occasions<br> 4. Not currently or within past three months receiving any treatment from a psychologist, psychotherapist or psychiatrist<br> 5. Willingness to be randomised to CCBT, at home or primary care facility or treatment as usual<br>", "exclusion_criteria": "Exclusion criteria: <br> 1. Unable to read or write English<br> 2. Beck Depression Inventory score of at least 29 on two consecutive occasions<br> 3. Active suicidal ideas<br> 4. Current or life-time diagnosis of any of the following:<br> 4.1. Psychosis<br> 4.2. Organic mental disorder<br> 4.3. Alcohol or drug dependency<br> 5. Kurtzke Expanded Disability Status Scale (EDSS) score of 8.5 or above<br> 6. Unable to use the CCBT package due to physical disability<br> 7. Unable to use the CCBT package due to cognitive symptoms (mini-mental state of 20 below or if, in the opinion of the study psychologist, the individual would be unlikely to benefit from CCBT)<br>", "condition": "Depression in people with multiple sclerosis (MS) <br>Mental and Behavioural Disorders <br>Depressive episodes in MS sufferers", "intervention": "<br> Participants are randomly allocated to one of two groups.<br><br> Intervention group: CBT software (Ultrasis - Beating the Blues®)<br> Control group: Treatment as usual<br><br> Ultrasis - Beating the Blues® is a computer-interactive programme for the treatment of anxiety and depression. It is based on cognitive behavioural therapy (CBT), which helps patients to identify and change unhelpful ways of thinking and to learn more effective ways of solving problems. The programme consists of two interwoven strands: the cognitive (or \"thinking\") strategies and the behavioural (or \"doing\") strategies. Patients are helped to understand the causes and symptoms of anxiety and depression and to work on their specific problems. The programme consists of a 15 minute \"Introduction to Therapy\" video plus eight computer-interactive sessions of approximately 50 minutes each in duration. Each session consists of a mix of cognitive and behavioural strategies, which are customised to the patient's individual problems. The eight computer sessions are designed to be taken weekly, or thereabouts, and each session builds on the previous one. Patients can repeat sessions if they wish. The computer keeps track of which session they have reached.<br><br> Total duration of interventions: 8 weeks<br> Total duration of follow-up: 3 months<br>", "primary_outcome": "Change in self-reported symptoms of depression: the difference between mean change scores of CCBT and standard care, as measured on the Beck Depression Inventory - Second Edition (BDI-II) 21-item self report instrument. Recorded at baseline, eight weeks or on completion of CCBT (whichever is later) and three months thereafter.", "secondary_outcome": "<br> The following will be recorded at baseline, eight weeks or on completion of CCBT (whichever is later) and three months thereafter:<br> 1. Depression as measured on the Patient Health Questionnaire-9 item (PHQ-9)<br> 2. Anxiety measured on the Generalised Anxiety Disorder-7 item (GAD-7)<br> 3. Disease-specific quality of life, measured on the Multiple Sclerosis Impact Scale-29 item (MSIS-29)<br> 4. Generic health-related quality of life, measured on the 36-item Short Form health survey (SF-36)<br>", "secondary_id": "NCT00678496;112276", "source_support": "Multiple Sclerosis Society (UK) (ref: 845/06)", "ethics_review_status": null, "ethics_review_approval_date": "1900-01-01", "ethics_review_contact_name": null, "ethics_review_contact_address": "Northern and Yorkshire NHS Research Ethics Committee, 05/09/2008, ref: 08/H0903/41", "ethics_review_contact_phone": null, "ethics_review_contact_email": null, "results_date_completed": "2010-01-31", "results_url_link": null } ] }