Trial List
List all clinical trials by discovery date. Accepts regular expressions in search.
GET /trials/?format=api&page=78
{ "count": 4842, "next": "http://api.gregory-ms.com/trials/?format=api&page=79", "previous": "http://api.gregory-ms.com/trials/?format=api&page=77", "results": [ { "trial_id": 3589, "title": "Safety of Polyphenon E in Multiple Sclerosis Pilot Study", "summary": null, "published_date": "2009-03-02T00:00:00Z", "discovery_date": "2023-12-06T18:18:20.611004Z", "link": "https://clinicaltrials.gov/show/NCT00836719", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT00836719" }, "categories": [], "export_date": "2024-04-27T00:00:00Z", "internal_number": "6492927", "last_refreshed_on": "2017-10-19", "scientific_title": "Safety and Neuroprotective Effects of Polyphenon E in Multiple Sclerosis", "primary_sponsor": "Louisiana State University Health Sciences Center in New Orleans", "retrospective_flag": "No", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Not recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "65 Years", "inclusion_gender": "All", "date_enrollement": "2009-02-27", "target_size": "10", "study_type": "Interventional", "study_design": null, "phase": "Phase 1", "countries": "United States;United States;United States;United States", "contact_firstname": "; ; ;", "contact_lastname": "Jesus F Lovera, MD, MSPH;Jesus F Lovera, MD, MSPH;Jesus F Lovera, MD, MSPH;Jesus F Lovera, MD, MSPH", "contact_address": null, "contact_email": ";;;", "contact_tel": ";;;", "contact_affiliation": "LSUHSC;LSUHSC;LSUHSC;LSUHSC", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - Diagnosis of MS by McDonald criteria\r<br>\r<br> - Relapsing-remitting MS or secondary progressive MS\r<br>\r<br> - Stable therapy with Copaxone, for at least six months prior to inclusion in the study\r<br> or no therapy for six months in subjects refusing therapy.\r<br>\r<br> - EDSS Score less than or equal to 6.5 (able to walk about 20 meters without resting)\r<br>\r<br> - Ages 18-60.\r<br>\r<br> - Leukocytes =3,000/µL\r<br>\r<br> - Absolute neutrophil count =1,500/µL\r<br>\r<br> - Platelets =100,000/µL\r<br>\r<br> - Total bilirubin =local upper limit of normal\r<br>\r<br> - normal AST (SGOT) ALT (SGPT)\r<br>\r<br> - normal serum Creatinine\r<br>\r<br> - women of child-bearing potential and men must agree to use adequate contraception\r<br> (hormonal or barrier method of birth control; abstinence) prior to study entry and for\r<br> the duration of study participation.\r<br>\r<br> - Ability to understand and the willingness to sign a written informed consent document.\r<br>\r<br> - Willing to drink at most one cup of black tea and two cups of coffee per day, and\r<br> abstain from drinking green tea or taking supplements containing green tea or green\r<br> tea compounds, for the duration of the investigation.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - MS relapse within the 30 days prior to enrollment.\r<br>\r<br> - A primary progressive form of MS.\r<br>\r<br> - Previous treatment prior to study entry as follows: complete radiation ablation of the\r<br> bone marrow or anti-CD4 antibody treatment (Campath) at any time; mitoxantrone,\r<br> cyclophosphamide, cyclosporin, Natalizumab or other immunomodulatory or\r<br> immunosuppressant therapies except for Copaxone or methylprednisone for relapses\r<br> within prior nine months.\r<br>\r<br> - History of renal or liver disease.\r<br>\r<br> - Consumption of green tea or supplements containing green tea or tea extract within 30\r<br> days prior to enrollment.\r<br>\r<br> - Participants may not participate in any other clinical trial involving investigational\r<br> agents during the study, or within six months prior to enrolling in the study.\r<br>\r<br> - history of allergic reactions attributed to compounds of similar chemical or biologic\r<br> composition to Polyphenon E, tea, or any of the inactive ingredients present in the\r<br> active or placebo capsules, including gelatin.\r<br>\r<br> - history of allergic reactions to gadolinium or any other condition contraindicated for\r<br> MRI.\r<br>\r<br> - Uncontrolled, clinically-relevant active illness (aside from MS) including, but not\r<br> limited to, ongoing or active infection, symptomatic congestive heart failure,\r<br> unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations\r<br> that would limit compliance with study requirements.\r<br>\r<br> - Any condition which would make the subject, in the opinion of the investigator,\r<br> unsuitable for the study.\r<br>\r<br> - Inability to complete the baseline MRI scan.\r<br>\r<br> - Pregnant or breastfeeding women.\r<br> ;\r<br> Inclusion Criteria:\r<br>\r<br> - Diagnosis of MS by McDonald criteria\r<br>\r<br> - Relapsing-remitting MS or secondary progressive MS\r<br>\r<br> - Stable therapy with Copaxone, for at least six months prior to inclusion in the study\r<br> or no therapy for six months in subjects refusing therapy.\r<br>\r<br> - EDSS Score less than or equal to 6.5 (able to walk about 20 meters without resting)\r<br>\r<br> - Ages 18-60.\r<br>\r<br> - Leukocytes =3,000/µL\r<br>\r<br> - Absolute neutrophil count =1,500/µL\r<br>\r<br> - Platelets =100,000/µL\r<br>\r<br> - Total bilirubin =local upper limit of normal\r<br>\r<br> - normal AST (SGOT) ALT (SGPT)\r<br>\r<br> - normal serum Creatinine\r<br>\r<br> - women of child-bearing potential and men must agree to use adequate contraception\r<br> (hormonal or barrier method of birth control; abstinence) prior to study entry and for\r<br> the duration of study participation.\r<br>\r<br> - Ability to understand and the willingness to sign a written informed consent document.\r<br>\r<br> - Willing to drink at most one cup of black tea and two cups of coffee per day, and\r<br> abstain from drinking green tea or taking supplements containing green tea or green\r<br> tea compounds, for the duration of the investigation.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - MS relapse within the 30 days prior to enrollment.\r<br>\r<br> - A primary progressive form of MS.\r<br>\r<br> - Previous treatment prior to study entry as follows: complete radiation ablation of the\r<br> bone marrow or anti-CD4 antibody treatment (Campath) at any time; mitoxantrone,\r<br> cyclophosphamide, cyclosporin, Natalizumab or other immunomodulatory or\r<br> immunosuppressant therapies except for Copaxone or methylprednisone for relapses\r<br> within prior nine months.\r<br>\r<br> - History of renal or liver disease.\r<br>\r<br> - Consumption of green tea or supplements containing green tea or tea extract within 30\r<br> days prior to enrollment.\r<br>\r<br> - Participants may not participate in any other clinical trial involving investigational\r<br> agents during the study, or within six months prior to enrolling in the study.\r<br>\r<br> - history of allergic reactions attributed to compounds of similar chemical or biologic\r<br> composition to Polyphenon E, tea, or any of the inactive ingredients present in the\r<br> active or placebo capsules, including gelatin.\r<br>\r<br> - history of allergic reactions to gadolinium or any other condition contraindicated for\r<br> MRI.\r<br>\r<br> - Uncontrolled, clinically-relevant active illness (aside from MS) including, but not\r<br> limited to, ongoing or active infection, symptomatic congestive heart failure,\r<br> unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations\r<br> that would limit compliance with study requirements.\r<br>\r<br> - Any condition which would make the subject, in the opinion of the investigator,\r<br> unsuitable for the study.\r<br>\r<br> - Inability to complete the baseline MRI scan.\r<br>\r<br> - Pregnant or breastfeeding women.\r<br> ;\r<br> Inclusion Criteria:\r<br>\r<br> - Diagnosis of MS by McDonald criteria\r<br>\r<br> - Relapsing-remitting MS or secondary progressive MS\r<br>\r<br> - Stable therapy with Copaxone, for at least six months prior to inclusion in the study\r<br> or no therapy for six months in subjects refusing therapy.\r<br>\r<br> - EDSS Score less than or equal to 6.5 (able to walk about 20 meters without resting)\r<br>\r<br> - Ages 18-60.\r<br>\r<br> - Leukocytes =3,000/µL\r<br>\r<br> - Absolute neutrophil count =1,500/µL\r<br>\r<br> - Platelets =100,000/µL\r<br>\r<br> - Total bilirubin =local upper limit of normal\r<br>\r<br> - normal AST (SGOT) ALT (SGPT)\r<br>\r<br> - normal serum Creatinine\r<br>\r<br> - women of child-bearing potential and men must agree to use adequate contraception\r<br> (hormonal or barrier method of birth control; abstinence) prior to study entry and for\r<br> the duration of study participation.\r<br>\r<br> - Ability to understand and the willingness to sign a written informed consent document.\r<br>\r<br> - Willing to drink at most one cup of black tea and two cups of coffee per day, and\r<br> abstain from drinking green tea or taking supplements containing green tea or green\r<br> tea compounds, for the duration of the investigation.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - MS relapse within the 30 days prior to enrollment.\r<br>\r<br> - A primary progressive form of MS.\r<br>\r<br> - Previous treatment prior to study entry as follows: complete radiation ablation of the\r<br> bone marrow or anti-CD4 antibody treatment (Campath) at any time; mitoxantrone,\r<br> cyclophosphamide, cyclosporin, Natalizumab or other immunomodulatory or\r<br> immunosuppressant therapies except for Copaxone or methylprednisone for relapses\r<br> within prior nine months.\r<br>\r<br> - History of renal or liver disease.\r<br>\r<br> - Consumption of green tea or supplements containing green tea or tea extract within 30\r<br> days prior to enrollment.\r<br>\r<br> - Participants may not participate in any other clinical trial involving investigational\r<br> agents during the study, or within six months prior to enrolling in the study.\r<br>\r<br> - history of allergic reactions attributed to compounds of similar chemical or biologic\r<br> composition to Polyphenon E, tea, or any of the inactive ingredients present in the\r<br> active or placebo capsules, including gelatin.\r<br>\r<br> - history of allergic reactions to gadolinium or any other condition contraindicated for\r<br> MRI.\r<br>\r<br> - Uncontrolled, clinically-relevant active illness (aside from MS) including, but not\r<br> limited to, ongoing or active infection, symptomatic congestive heart failure,\r<br> unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations\r<br> that would limit compliance with study requirements.\r<br>\r<br> - Any condition which would make the subject, in the opinion of the investigator,\r<br> unsuitable for the study.\r<br>\r<br> - Inability to complete the baseline MRI scan.\r<br>\r<br> - Pregnant or breastfeeding women.\r<br> ;\r<br> Inclusion Criteria:\r<br>\r<br> - Diagnosis of MS by McDonald criteria\r<br>\r<br> - Relapsing-remitting MS or secondary progressive MS\r<br>\r<br> - Stable therapy with Copaxone, for at least six months prior to inclusion in the study\r<br> or no therapy for six months in subjects refusing therapy.\r<br>\r<br> - EDSS Score less than or equal to 6.5 (able to walk about 20 meters without resting)\r<br>\r<br> - Ages 18-60.\r<br>\r<br> - Leukocytes =3,000/µL\r<br>\r<br> - Absolute neutrophil count =1,500/µL\r<br>\r<br> - Platelets =100,000/µL\r<br>\r<br> - Total bilirubin =local upper limit of normal\r<br>\r<br> - normal AST (SGOT) ALT (SGPT)\r<br>\r<br> - normal serum Creatinine\r<br>\r<br> - women of child-bearing potential and men must agree to use adequate contraception\r<br> (hormonal or barrier method of birth control; abstinence) prior to study entry and for\r<br> the duration of study participation.\r<br>\r<br> - Ability to understand and the willingness to sign a written informed consent document.\r<br>\r<br> - Willing to drink at most one cup of black tea and two cups of coffee per day, and\r<br> abstain from drinking green tea or taking supplements containing green tea or green\r<br> tea compounds, for the duration of the investigation.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - MS relapse within the 30 days prior to enrollment.\r<br>\r<br> - A primary progressive form of MS.\r<br>\r<br> - Previous treatment prior to study entry as follows: complete radiation ablation of the\r<br> bone marrow or anti-CD4 antibody treatment (Campath) at any time; mitoxantrone,\r<br> cyclophosphamide, cyclosporin, Natalizumab or other immunomodulatory or\r<br> immunosuppressant therapies except for Copaxone or methylprednisone for relapses\r<br> within prior nine months.\r<br>\r<br> - History of renal or liver disease.\r<br>\r<br> - Consumption of green tea or supplements containing green tea or tea extract within 30\r<br> days prior to enrollment.\r<br>\r<br> - Participants may not participate in any other clinical trial involving investigational\r<br> agents during the study, or within six months prior to enrolling in the study.\r<br>\r<br> - history of allergic reactions attributed to compounds of similar chemical or biologic\r<br> composition to Polyphenon E, tea, or any of the inactive ingredients present in the\r<br> active or placebo capsules, including gelatin.\r<br>\r<br> - history of allergic reactions to gadolinium or any other condition contraindicated for\r<br> MRI.\r<br>\r<br> - Uncontrolled, clinically-relevant active illness (aside from MS) including, but not\r<br> limited to, ongoing or active infection, symptomatic congestive heart failure,\r<br> unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations\r<br> that would limit compliance with study requirements.\r<br>\r<br> - Any condition which would make the subject, in the opinion of the investigator,\r<br> unsuitable for the study.\r<br>\r<br> - Inability to complete the baseline MRI scan.\r<br>\r<br> - Pregnant or breastfeeding women.\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis;Multiple Sclerosis;Multiple Sclerosis;Multiple Sclerosis", "intervention": "Drug: Polyphenon E;Drug: Polyphenon E;Drug: Polyphenon E;Drug: Polyphenon E", "primary_outcome": "Number of Participants Experiencing Serious Adverse Events;Number of Participants Experiencing Serious Adverse Events", "secondary_outcome": "Change in Brain NAA Level as Measured by MR Spectroscopy", "secondary_id": "K23AT004433-01;1K23AT004433-01;K23AT004433-01", "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": 3588, "title": "Lokomat Treadmill Training Effects on MS Gait", "summary": null, "published_date": "2009-03-02T00:00:00Z", "discovery_date": "2023-12-06T18:18:20.584636Z", "link": "https://clinicaltrials.gov/show/NCT00835835", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT00835835" }, "categories": [], "export_date": "2024-04-27T00:00:00Z", "internal_number": "5234285", "last_refreshed_on": "2015-11-23", "scientific_title": "Lokomat Treadmill Training Effects on MS Gait", "primary_sponsor": "Mount Sinai Rehabilitation Hospital", "retrospective_flag": "No", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Not recruiting", "other_records": "No", "inclusion_agemin": "25 Years", "inclusion_agemax": "60 Years", "inclusion_gender": "Both", "date_enrollement": "2008-02-27", "target_size": "8", "study_type": "Interventional", "study_design": "Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment", "phase": "N/A", "countries": "United States", "contact_firstname": "", "contact_lastname": "Albert Lo, MD, PhD", "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": "Mandell Center for Multiple Sclerosis at Mount Sinai Rehabilitation Hospital", "inclusion_criteria": "<br> Main Inclusion Criteria:\r<br>\r<br> - Clinical diagnosis of MS\r<br>\r<br> - EDSS level between 3.5-6.0\r<br>\r<br> - Problems with ambulation\r<br>\r<br> - able to ambulate 25 feet without an assistive device\r<br>\r<br> Main Exclusion Criteria:\r<br>\r<br> - Lower extremity injuries that limit range of motion or function\r<br>\r<br> - Unable to demonstrate an understanding of the process of the study and or fully\r<br> understand instructions in order to safely participate in the study and use study\r<br> equipment\r<br>\r<br> - Body weight over 150 kg\r<br>\r<br> - complete inclusion/exclusion criteria listed in consent form\r<br>", "exclusion_criteria": null, "condition": "Gait, Unsteady;Multiple Sclerosis", "intervention": "Other: Body-weight supported treadmill training +/- Lokomat assistance;Other: Usual Care - no active intervention", "primary_outcome": "Gait Parameters", "secondary_outcome": null, "secondary_id": "AL0001", "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": 3587, "title": "A 24-Hour Pharmacokinetic Determination of BG00012 After Single-Day Oral Administration in Subjects With MS", "summary": null, "published_date": "2009-04-02T00:00:00Z", "discovery_date": "2023-12-06T18:18:20.562747Z", "link": "https://clinicaltrials.gov/show/NCT00837785", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT00837785" }, "categories": [], "export_date": "2024-04-27T00:00:00Z", "internal_number": "10206967", "last_refreshed_on": "2020-12-12", "scientific_title": "A 24-Hour Pharmacokinetic Determination of BG00012 After Single-Day Oral Administration in Subjects With Multiple Sclerosis", "primary_sponsor": "Biogen", "retrospective_flag": "Yes", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Not recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "55 Years", "inclusion_gender": "All", "date_enrollement": "2009-02-28", "target_size": "48", "study_type": "Interventional", "study_design": "Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: None (Open Label).", "phase": "Phase 1", "countries": "Germany;United Kingdom", "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. Aged 18 to 55 years old, inclusive, at the time of informed consent.\r<br>\r<br> 2. Have a confirmed diagnosis of RRMS according to McDonald criteria #1-4.\r<br>\r<br> 3. Be ambulatory.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> 1. Primary progressive, secondary progressive, or progressive-relapsing multiple\r<br> sclerosis (PRMS).\r<br>\r<br> 2. History of any clinically significant cardiac, endocrinologic, hematologic, hepatic,\r<br> immunologic, metabolic, urologic, pulmonary, neurologic (other than MS), dermatologic,\r<br> psychiatric, renal, oncologic, anaphylaxis or other major diseases, as determined by\r<br> the Investigator.\r<br>\r<br> 3. Current enrollment in any other drug, biologic, or device study or treatment with\r<br> another investigational drug within 6 months or 5 half-lives of the investigational\r<br> product, whichever time period is longer.\r<br>\r<br> 4. Serious infection (e.g., pneumonia, septicemia) within the 2 months prior to Day -1.\r<br>\r<br> 5. Pregnant or nursing women.\r<br>\r<br> Other protocol-defined inclusion/exclusion criteria may apply.\r<br>", "exclusion_criteria": null, "condition": "Relapsing Remitting Multiple Sclerosis", "intervention": "Drug: BG00012;Drug: BG00012", "primary_outcome": "To establish a PK profile of MMF during a 24-hour BG00012 dosing period in subjects with RRMS", "secondary_outcome": "To explore the relationship of differences in baseline demographics and dosing factors in the disposition of BG00012", "secondary_id": "109MS101", "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": 3586, "title": "Exercise Intervention for Multiple Sclerosis: the Sheffield ExIMS trial", "summary": null, "published_date": "2009-05-02T00:00:00Z", "discovery_date": "2023-12-06T18:18:20.542499Z", "link": "http://isrctn.com/ISRCTN41541516", "source": "WHO XML import", "relevant": null, "identifiers": { "isrctn": "ISRCTN41541516" }, "categories": [], "export_date": "2024-04-27T00:00:00Z", "internal_number": "6720504", "last_refreshed_on": "2018-01-08", "scientific_title": "The effects of a pragmatic exercise therapy intervention on physical activity and important health outcomes influencing maintenance in people with multiple sclerosis (PWMS)", "primary_sponsor": "Sheffield Teaching Hospitals NHS Foundation 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": "2009-01-01", "target_size": "120", "study_type": "Interventional", "study_design": "Randomised controlled trial (Treatment)", "phase": "Not Applicable", "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. Clinical diagnosis of MS with an Expanded Disability Status Scale (EDSS) score of between 1.0 - 6.5, and able to walk 10 m distance<br>2. Aged 18 - 65 years, either sex<br>3. Participants must have been clinically stable for at least 4 weeks prior to entering the study<br>4. Participants on disease modifying therapy (interferon and glatiramer acetate) must have been stable on this treatment for at least 3 months prior to entering the study<br>5. Physically able to participate in some form of exercise three times per week<br>6. Able to provide written informed consent", "exclusion_criteria": "Exclusion criteria: 1. Failure to meet any of the above inclusion criteria<br>2. Experiencing illness that impairs their ability to be physically active three times per week<br>3. Not willing to be randomised to either the exercise intervention or usual care control group<br>4. Living more than 20 miles from the trial centre<br>5. Already engaged in purposeful structured exercise or brisk walking exercise for equal to or greater than three times per week for equal to or greater than 30 minutes per session and have been so on a consistent basis during the previous six months", "condition": "Multiple sclerosis <br>Nervous System Diseases <br>Multiple sclerosis", "intervention": "Exercise Group: <br>A 12-week intervention period is planned for the exercise group, with a more frequent contact phase during the first 6-week block (two supervised exercise sessions at the centre and one home-based session a week), and reduced contact during the second 6-week block (one supervised session and two home-based sessions a week). Sessions will be conducted in small groups (up to 3 PWMS) and will consist of short bouts (e.g. 5 x 3-min, with 2-minute rest intervals) of low to moderate intensity exercise (50 - 69% maximum heart rate). In accordance with recent recommendations the intervention will be stage-adapted and participants will be encouraged to exercise within their own capabilities. <br><br>Usual Care: <br>The usual care group will continue with their normal support during this time period.", "primary_outcome": "1. Physical activity levels <br>2. Six-minute walking test<br><br>All outcome measures will be taken at baseline, 12-weeks and at 6-months follow-up.", "secondary_outcome": "1. Neurological impairment and clinical functional mobility<br>2. Quality of life<br>3. Fatigue<br>4. Focus groups and interviews<br>5. Immunological analysis<br><br>All outcome measures will be taken at baseline, 12-weeks and at 6-months follow-up.", "secondary_id": "Version 1: 15/08/08", "source_support": "Multiple Sclerosis Society (UK)", "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": 3585, "title": "Trial of Ginkgo as a Treatment for Cognitive Problems in Multiple Sclerosis", "summary": null, "published_date": "2009-09-02T00:00:00Z", "discovery_date": "2023-12-06T18:18:20.524065Z", "link": "https://clinicaltrials.gov/show/NCT00841321", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT00841321" }, "categories": [], "export_date": "2024-04-27T00:00:00Z", "internal_number": "6493000", "last_refreshed_on": "2017-10-19", "scientific_title": "Ginkgo Biloba for Cognitive Impairment in Multiple Sclerosis", "primary_sponsor": "VA Office of Research and Development", "retrospective_flag": "No", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Not recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "65 Years", "inclusion_gender": "All", "date_enrollement": "2009-01-27", "target_size": "120", "study_type": "Interventional", "study_design": null, "phase": "Phase 2", "countries": "United States;United States;United States;United States", "contact_firstname": "; ; ;", "contact_lastname": "Dennis N. Bourdette, MD;Dennis N. Bourdette, MD;Dennis N. Bourdette, MD;Dennis N. Bourdette, MD", "contact_address": null, "contact_email": ";;;", "contact_tel": ";;;", "contact_affiliation": "Portland VA Medical Center, Portland, OR;Portland VA Medical Center, Portland, OR;Portland VA Medical Center, Portland, OR;Portland VA Medical Center, Portland, OR", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - A diagnosis of multiple sclerosis by McDonald's criteria\r<br>\r<br> - Age 18 to 65 years, inclusive\r<br>\r<br> - A score minus one standard deviation below the mean on one or more of the following\r<br> tests: PASAT, COWAT, CVLT-II, Stroop\r<br>\r<br> - EDSS 0 - 7.5, inclusive\r<br>\r<br> - No Ginkgo biloba in preceding 30 days\r<br>\r<br> - Native English speaker\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Current substance abuse disorder, psychosis, or significant depression (score on the\r<br> Beck Depression Inventory II (BDI -II) greater than 28\r<br>\r<br> - Any significant uncontrolled medical problem including diabetes requiring insulin\r<br>\r<br> - Relapse of multiple sclerosis within the 30 days before screening\r<br>\r<br> - Abnormalities of coagulation or current use of anticoagulants or antiplatelet agents\r<br>\r<br> - Elective surgery planned for the study period or the following four weeks\r<br>\r<br> - Epilepsy or history of seizures\r<br>\r<br> - Use of nifedipine, nicardipine, Saint John's Wort, papaverine, mono amine oxidase\r<br> inhibitors\r<br>\r<br> - Pregnancy or women not using a reliable form of contraception\r<br>\r<br> - Corrected binocular visual acuity worse than 20/50 or more than one error on binocular\r<br> color vision testing with the Ishihara Color Plates or sustained nystagmus or diplopia\r<br> on primary gaze\r<br>\r<br> - Inability to complete the neuropsychological test battery at the screening visit\r<br>\r<br> - History of alcohol abuse or illicit drug use in the prior six months\r<br> ;\r<br> Inclusion Criteria:\r<br>\r<br> - A diagnosis of multiple sclerosis by McDonald's criteria\r<br>\r<br> - Age 18 to 65 years, inclusive\r<br>\r<br> - A score minus one standard deviation below the mean on one or more of the following\r<br> tests: PASAT, COWAT, CVLT-II, Stroop\r<br>\r<br> - EDSS 0 - 7.5, inclusive\r<br>\r<br> - No Ginkgo biloba in preceding 30 days\r<br>\r<br> - Native English speaker\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Current substance abuse disorder, psychosis, or significant depression (score on the\r<br> Beck Depression Inventory II (BDI -II) greater than 28\r<br>\r<br> - Any significant uncontrolled medical problem including diabetes requiring insulin\r<br>\r<br> - Relapse of multiple sclerosis within the 30 days before screening\r<br>\r<br> - Abnormalities of coagulation or current use of anticoagulants or antiplatelet agents\r<br>\r<br> - Elective surgery planned for the study period or the following four weeks\r<br>\r<br> - Epilepsy or history of seizures\r<br>\r<br> - Use of nifedipine, nicardipine, Saint John's Wort, papaverine, mono amine oxidase\r<br> inhibitors\r<br>\r<br> - Pregnancy or women not using a reliable form of contraception\r<br>\r<br> - Corrected binocular visual acuity worse than 20/50 or more than one error on binocular\r<br> color vision testing with the Ishihara Color Plates or sustained nystagmus or diplopia\r<br> on primary gaze\r<br>\r<br> - Inability to complete the neuropsychological test battery at the screening visit\r<br>\r<br> - History of alcohol abuse or illicit drug use in the prior six months\r<br> ;\r<br> Inclusion Criteria:\r<br>\r<br> - A diagnosis of multiple sclerosis by McDonald's criteria\r<br>\r<br> - Age 18 to 65 years, inclusive\r<br>\r<br> - A score minus one standard deviation below the mean on one or more of the following\r<br> tests: PASAT, COWAT, CVLT-II, Stroop\r<br>\r<br> - EDSS 0 - 7.5, inclusive\r<br>\r<br> - No Ginkgo biloba in preceding 30 days\r<br>\r<br> - Native English speaker\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Current substance abuse disorder, psychosis, or significant depression (score on the\r<br> Beck Depression Inventory II (BDI -II) greater than 28\r<br>\r<br> - Any significant uncontrolled medical problem including diabetes requiring insulin\r<br>\r<br> - Relapse of multiple sclerosis within the 30 days before screening\r<br>\r<br> - Abnormalities of coagulation or current use of anticoagulants or antiplatelet agents\r<br>\r<br> - Elective surgery planned for the study period or the following four weeks\r<br>\r<br> - Epilepsy or history of seizures\r<br>\r<br> - Use of nifedipine, nicardipine, Saint John's Wort, papaverine, mono amine oxidase\r<br> inhibitors\r<br>\r<br> - Pregnancy or women not using a reliable form of contraception\r<br>\r<br> - Corrected binocular visual acuity worse than 20/50 or more than one error on binocular\r<br> color vision testing with the Ishihara Color Plates or sustained nystagmus or diplopia\r<br> on primary gaze\r<br>\r<br> - Inability to complete the neuropsychological test battery at the screening visit\r<br>\r<br> - History of alcohol abuse or illicit drug use in the prior six months\r<br> ;\r<br> Inclusion Criteria:\r<br>\r<br> - A diagnosis of multiple sclerosis by McDonald's criteria\r<br>\r<br> - Age 18 to 65 years, inclusive\r<br>\r<br> - A score minus one standard deviation below the mean on one or more of the following\r<br> tests: PASAT, COWAT, CVLT-II, Stroop\r<br>\r<br> - EDSS 0 - 7.5, inclusive\r<br>\r<br> - No Ginkgo biloba in preceding 30 days\r<br>\r<br> - Native English speaker\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Current substance abuse disorder, psychosis, or significant depression (score on the\r<br> Beck Depression Inventory II (BDI -II) greater than 28\r<br>\r<br> - Any significant uncontrolled medical problem including diabetes requiring insulin\r<br>\r<br> - Relapse of multiple sclerosis within the 30 days before screening\r<br>\r<br> - Abnormalities of coagulation or current use of anticoagulants or antiplatelet agents\r<br>\r<br> - Elective surgery planned for the study period or the following four weeks\r<br>\r<br> - Epilepsy or history of seizures\r<br>\r<br> - Use of nifedipine, nicardipine, Saint John's Wort, papaverine, mono amine oxidase\r<br> inhibitors\r<br>\r<br> - Pregnancy or women not using a reliable form of contraception\r<br>\r<br> - Corrected binocular visual acuity worse than 20/50 or more than one error on binocular\r<br> color vision testing with the Ishihara Color Plates or sustained nystagmus or diplopia\r<br> on primary gaze\r<br>\r<br> - Inability to complete the neuropsychological test battery at the screening visit\r<br>\r<br> - History of alcohol abuse or illicit drug use in the prior six months\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis;Cognitive Ability, General;Multiple Sclerosis;Cognitive Ability, General;Multiple Sclerosis;Cognitive Ability, General;Multiple Sclerosis;Cognitive Ability, General", "intervention": "Drug: Ginkgo biloba;Drug: Placebo;Drug: Ginkgo biloba;Drug: Placebo;Drug: Ginkgo biloba;Drug: Placebo;Drug: Ginkgo biloba;Drug: Placebo", "primary_outcome": "Primary Outcome is Performance on the Interference Condition of the Stroop, the Long Delay Free Recall Portion of the California Verbal Learning Test II, the 2 Second Paced Auditory Serial Addition Test and the Controlled Oral Word Association Test.;Primary Outcome is Performance on the Interference Condition of the Stroop, the Long Delay Free Recall Portion of the California Verbal Learning Test II, the 2 Second Paced Auditory Serial Addition Test and the Controlled Oral Word Association Test.", "secondary_outcome": "Secondary Outcome: Measures of Self-report as Well as Family Reports of Subject's Cognitive Deficits and Assessment of Social Integration.", "secondary_id": "B4368-R", "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": 3584, "title": "Recombinant IFN alpha-2b for relapsing –remitting multiple sclerosis.", "summary": null, "published_date": "2009-11-02T00:00:00Z", "discovery_date": "2023-12-06T18:18:20.503800Z", "link": "https://rpcec.sld.cu/en/trials/RPCEC00000073-En", "source": "WHO XML import", "relevant": null, "identifiers": { "rpcec": "RPCEC00000073" }, "categories": [], "export_date": "2024-04-27T00:00:00Z", "internal_number": "13834725", "last_refreshed_on": "2024-04-01", "scientific_title": "Recombinant IFN alpha-2b for relapsing –remitting multiple sclerosis. Phase III, randomized, double blind, placebo-controlled clinical trial.", "primary_sponsor": "Center for Genetic Engineering and Biotechnology, La Habana.", "retrospective_flag": "No", "date_registration": null, "source_register": "RPCEC", "recruitment_status": "Not Recruiting", "other_records": "No", "inclusion_agemin": "18 years", "inclusion_agemax": "50 years", "inclusion_gender": "Male/Female", "date_enrollement": "1995-05-13", "target_size": "159", "study_type": "Interventional", "study_design": "Allocation: Randomized controlled trial. Masking: Double Blind. Control group: Placebo. Assignment: Parallel. Purpose: Treatment", "phase": "2-3", "countries": "Cuba", "contact_firstname": "Giselle", "contact_lastname": "Rol", "contact_address": "31st Ave. between 158 and 190, Cubanacan, Playa.", "contact_email": "[email protected]", "contact_tel": null, "contact_affiliation": "Center for Genetic Engineering and Biothecnology (CIGB), in Havana.", "inclusion_criteria": "Inclusion criteria: 1.Diagnosis of relapsing remitting multiple sclerosis defined according to Poser criteria. 2.Clinically stable patients for at least 30 days without having received any treatment with steroids during this time. 3.Duration of the disease of two years having 2 relapses at least. 4.Score of 6.5 or less in the Kurtzke EDSS scale. 5.18 to 50 years of age. 6.Patient willingness through informed consent signature.", "exclusion_criteria": "Exclusion criteria: 1.Being in the acute phase of the disease. 2.Progressive clinical form. 3.Presence of any disease explaining the clinical symptoms or unfavorable outcome having a defined therapeutic behavior. 4.Pregnancy or puerpery. 5.Women in fertile age during contraceptive hormonal therapy. 6.Having received treatment with aziathroprina or Cyclofosfamide during the last year. 7.Uncontrolled chronic disease (heart, liver or kidney failure). 8.IFN hypersensitivity background.", "condition": "Relapsing-remitting multiple sclerosis, clinically defined according to Poser criteria (Ann Neurol 1983; 13: 227-231).", "intervention": "Group I: Recombinant IFN alpha-2b, 10 x 106 UI by intramuscular route, twice a week separated by 3 days at least for two years. Group II: Recombinant IFN alpha-2b, 3 x 106 UI by intramuscular route, twice a week separated by 3 days at least for two years. Group III: Placebo by intramuscular route, twice a week separated by 3 days at least for two years.", "primary_outcome": "The mean number of relapses per patient in each group during the two years of treatment.", "secondary_outcome": "1.Proportion of patients without relapses during the two years of treatment. 2.Variation in the Scripps-NRS scale at the beginning, annually and during relapses. 3.Variations in the degree of disability according to the Kurtzke EDSS at the beginning and annually. 4.Magnetic Resonance Imaging at the beginning and annually in a group of cases. 5.Evaluation of the cognitive function in a group of patients. 6.Treatment safety (occurrence of adverse events).", "secondary_id": "IG/IAI/EM/9501.", "source_support": "Heber Biotec S.A. and Cuban Ministry of Public Health.", "ethics_review_status": null, "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": null, "results_url_link": null }, { "trial_id": 3583, "title": "The Effectiveness of Locomotor Therapy Using Robot-Driven Gait Orthosis System in Multiple Sclerosis Patients", "summary": null, "published_date": "2009-12-02T00:00:00Z", "discovery_date": "2023-12-06T18:18:20.485911Z", "link": "http://clinicaltrials.gov/show/NCT00843128", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT00843128" }, "categories": [], "export_date": "2024-04-27T00:00:00Z", "internal_number": "4653957", "last_refreshed_on": "2015-02-19", "scientific_title": "Phase II Study of the Effectiveness of Locomotor Therapy Using Robot-Driven Gait Orthosis System in Acute Stroke Patients: A Randomized Controlled Trial.", "primary_sponsor": "Hadassah Medical Organization", "retrospective_flag": "Yes", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Not recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "70 Years", "inclusion_gender": "Both", "date_enrollement": "2009-03-27", "target_size": "40", "study_type": "Interventional", "study_design": "Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment", "phase": "Phase 2", "countries": "Israel", "contact_firstname": "", "contact_lastname": "Zeev Meiner, M.D.", "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": "Hadassah Medical Organization", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> 1. chronic or secondary progressive MS patients with EDSS between 5.5-7,\r<br>\r<br> 2. stable treatment 3 months before study entry.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> 1. Other generalized diseases.\r<br>\r<br> 2. Pregnancy.\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis", "intervention": "Device: robot-assisted gait training (RAGT);Device: conventional walking training (CWT)", "primary_outcome": "Functional Ambulatory Capacity (FAC) scale and the 6-minutes walking distance", "secondary_outcome": "Time up & Go (TUG) test, 10 Meter Walking test, Berg balance test, EDSS score, FIM score and SF36 questioner for quality of life.", "secondary_id": "0558-08-HMO-CTIL", "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": 3582, "title": "A phase II, double-blind, randomized, multi-center, adaptive dose-ranging, placebo-controlled, parallel-group study evaluating safety, tolerability and efficacy on MRI lesion parameters and determining the dose response curve of BAF312 given orally once daily in patients with relapsing-remitting multiple sclerosis", "summary": null, "published_date": "2009-02-16T00:00:00Z", "discovery_date": "2023-12-06T18:18:20.463697Z", "link": "https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-008719-25", "source": "WHO XML import", "relevant": null, "identifiers": { "euctr": "EUCTR2008-008719-25-DE" }, "categories": [ { "category_id": 13, "category_description": "Siponimod (also known as BAF312 or Mayzent) is a tablet being developed for secondary progressive MS by Novartis Pharmaceuticals. It was licensed by the European Medicines Agency (EMA) on Monday 20 January 2020.\n\nhttps://www.mssociety.org.uk/research/explore-our-research/emerging-research-and-treatments/explore-treatments-in-trials/siponimod", "category_name": "Siponimod", "category_slug": "siponimod", "category_terms": [ "siponimod", "BAF312", "Mayzent" ], "article_count": 46 } ], "export_date": "2024-04-27T00:00:00Z", "internal_number": "2579327", "last_refreshed_on": "2012-05-01", "scientific_title": "A phase II, double-blind, randomized, multi-center, adaptive dose-ranging, placebo-controlled, parallel-group study evaluating safety, tolerability and efficacy on MRI lesion parameters and determining the dose response curve of BAF312 given orally once daily in patients with relapsing-remitting 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": null, "target_size": "275", "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: yes\nOther trial design description: adaptive dose-ranging\nIf controlled, specify comparator, Other Medicinial Product: no\nPlacebo: yes\nOther: no", "phase": null, "countries": "Hungary;Finland;Germany;Spain;Italy", "contact_firstname": null, "contact_lastname": null, "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": null, "inclusion_criteria": "Inclusion criteria: <br>1. Patients must give written informed consent before any assessment is performed<br>2. 18 through 55 years of age inclusive<br>3. Male or female<br>4. Females of childbearing potential:<br>• must have a negative pregnancy test at Baseline prior to entry into the double-blind treatment phase<br>• must simultaneously use two forms of effective contraception (either partner) during the treatment and for one<br>months or one menstrual cycle, whichever is longer after discontinuation of the study drug<br>• if either post-menopausal for 12 months prior to randomization or surgically sterile (through hysterectomy<br>or bilateral oophorectomy, if documented), are not required to use birth control (refer to Section 8.3 for more<br>details)<br>5. Diagnosis of MS as defined by revised McDonald criteria (see Appendix 4)<br>6. A relapsing-remitting course of disease with<br>• at least 1 documented relapse during the previous year, or<br>• 2 documented relapses during the previous 2 years, or<br>• a positive Gd-enhanced MRI scan at screening (in case the first MRI scan obtained at screening is negative, a<br>second scan may be obtained 1 month later)<br>7. An Expanded Disability Status Scale (EDSS) score of 0-5.0 inclusive at randomization<br>8. Neurologically stable with no evidence of relapse or corticosteroid treatment within 30 days prior to<br>randomization<br>9. Patients who decline initiation or continuation of treatment with available disease modifying drugs for MS, for<br>whatever reason, after having been informed about their respective benefits and possible adverse events by the<br>investigator.<br>10. Is willing to refrain from submersion in water while wearing the MCT adherent device during dose titration<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. Another type of MS than RRMS<br>2. History of chronic disease of the immune system other than MS, or a known immunodeficiency syndrome<br>3. Malignancy (except for successfully-treated basal or squamous cell carcinoma of skin)<br>4. Known, or ‘new’ diagnosis of diabetes mellitus (if screening blood glucose is suspicious for diabetes a patient should be further evaluated)<br>5. Macular edema during pre-randomization<br>6. Active systemic bacterial, viral or fungal infections, or AIDS, hepatitis B, hepatitis C infection defined as a positive HIV AB, hepatitis B surface AG or hepatitis C AB tests<br>7. Negative for varicella-zoster virus IgG AB at screening<br>8. Live or live attenuated vaccination within 2 m<br>9. Total lymphoid irradiation or bone marrow transplantation<br>10. Have been treated with:<br>• ACTH or oral or injected corticosteroids within 1 m<br>• IFN-ß or glatiramer acetate within 3 m<br>• immunosuppressive medications such as azathioprine or methotrexate within<br>6 m<br>• immunoglobulins and/or monoclonal ABs (including natalizumab) within 6 m (this rule does not apply for alemtuzumab, rituximab)<br>• alemtuzumab, rituximab, cladribine, cyclophosphamide, mitoxantrone, or other immunosuppressive treatments with effects potentially lasting over 6 m, at any time<br>11. Any medically unstable condition, as assessed by the primary treating physician<br>12. Any of the following CV conditions<br>• history or presence of stable or unstable IHD, MI, myocarditis or cardiomyopathy<br>• history of Raynaud’s disease<br>• cardiac failure (NYHA class II - IV) at screening and/or at baseline, or any severe cardiac disease as determined by the investigator<br>• history of cardiac arrest<br>• history of symptomatic bradycardia<br>• resting pulse rate < 55 bpm<br>• history or presence of a clinically relevant impairment of cardiac conduction including sick sinus syndrome, sino-atrial block<br>• clinically significant AVB, bundle branch block or an increased QTc interval > 440 msec on screening ECG<br>• history or presence of symptomatic arrhythmia or arrhythmia requiring treatment or being otherwise of clinical significance<br>• arterial hypertension, uncontrolled by medication<br>• treatment with medication that impairs cardiac conduction<br>• history of syncopes of suspected cardiac origin<br>• history of catheter ablation<br>13. Any of the following pulmonary conditions:<br>• severe respiratory disease or pulmonary fibrosis<br>• tuberculosis, except for history of successfully treated TB or history of prophylactic treatment after positive PPD skin reaction<br>• abnormal chest High Resolution Computer Tomography (HRCT), chest X-Ray or chest MRI suggestive of active pulmonary disease<br>• abnormal Pulmonary Function Tests: forced expiratory volume in 1 second (FEV1) or forced vital capacity<br>(FVC) values lower than 70% of predicted value<br>• patients receiving chronic (daily) therapies for asthma<br>14. Any of the following hepatic conditions:<br>• chronic liver or biliary disease<br>• total bilirubin >ULN unless in context of Gilbert’s syndrome<br>• conjugated bilirubin >ULN<br>• alkaline phosphatase (AP) >1.5 x ULN<br>• AST or SGOT, ALT or SGPT >2 x ULN<br>• GGT >3 x ULN<br>15. Any of the following abnormal laboratory values:<br>• potassium >ULN<br>• serum creatinine > 1.7 mg/dL (150 µmol/L)<br>• white blood cell count < 3,500/mm3 (< 3.5 x 109/L)<br>• lymphocyte count < 800/mm3 (< 0.8 x 109/L)<br>16. Any of the following neurological/psychiatric disorders:<br>• history or presence of substance abuse (any illicit or prescription drugs or alcohol)<br>• progressive neurological disorde", "condition": "Relapsing-remitting multiple sclerosis <br>MedDRA version: 9.1\nLevel: PT\nClassification code 10063399\nTerm: Relapsing-remitting multiple sclerosis", "intervention": "<br>Product Code: BAF312<br>Pharmaceutical Form: Film-coated tablet<br>Current Sponsor code: BAF312<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 0.25-<br>Pharmaceutical form of the placebo: Film-coated tablet<br>Route of administration of the placebo: Oral use<br><br>Product Code: BAF312<br>Pharmaceutical Form: Film-coated tablet<br>Current Sponsor code: BAF312<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 1-<br>Pharmaceutical form of the placebo: Film-coated tablet<br>Route of administration of the placebo: Oral use<br><br>Product Code: BAF312<br>Pharmaceutical Form: Film-coated tablet<br>Current Sponsor code: BAF312<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 4-<br>Pharmaceutical form of the placebo: Film-coated tablet<br>Route of administration of the placebo: Oral use<br><br>Product Code: BAF312<br>Pharmaceutical Form: Film-coated tablet<br>Current Sponsor code: BAF312<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 5-<br>Pharmaceutical form of the placebo: Film-coated tablet<br>Route of administration of the placebo: Oral use<br><br>Product Name: BAF312<br>Product Code: BAF312<br>Pharmaceutical Form: Film-coated tablet<br>Current Sponsor code: BAF312<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 0.1-<br>Pharmaceutical form of the placebo: Film-coated tablet<br>Route of administration of the placebo: Oral use<br><br>", "primary_outcome": "Main Objective: The primary objective of this study is to evaluate the dose response relationship among five doses of BAF312 and placebo during 3 months of treatment in patients with RRMS, as measured by the number of combined unique active [MRI] lesions (CUAL). ;Secondary Objective: • To evaluate the safety and tolerability (including blood pressure effects) of BAF312 during 6 months and 3 months of treatment in MS patients<br>• To evaluate the dose response relationship of BAF312 and placebo during 6 months of treatment in patients with RRMS, as measured by CUAL<br>• To explore the effect of BAF312 on the number of relapses and thereof derived measures (e.g. annualized relapse rate (ARR), proportion of relapse-free patients)<br>• To explore the correlation of the course of the lymphocyte count with paraclinical (MRI activity) and clinical course<br>;Primary end point(s): Monthly number of combined unique active MRI lesions (CUAL) during 3 months of treatment. Combined unique active lesions are defined as new gadolinium [Gd]-enhancing lesions on T1-weighted MRI scans or new or enlarging lesions on T2-weighted MRI scans, without double-counting of lesions.<br>", "secondary_outcome": null, "secondary_id": "CBAF312A2201", "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": 3581, "title": "Atacicept in Multiple Sclerosis Extension Study, Phase II", "summary": null, "published_date": "2009-02-26T00:00:00Z", "discovery_date": "2023-12-06T18:18:20.439202Z", "link": "https://clinicaltrials.gov/show/NCT00853762", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT00853762" }, "categories": [], "export_date": "2024-04-27T00:00:00Z", "internal_number": "6613347", "last_refreshed_on": "2017-12-16", "scientific_title": "An Open-label, Multicenter Phase II Extension of Study 28063 (ATAMS) to Obtain Long-term Follow-up Data in Subjects With Relapsing Multiple Sclerosis Treated With Atacicept for up to 5 Years (ATAMS-Extension)", "primary_sponsor": "EMD Serono", "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": "2009-03-27", "target_size": "74", "study_type": "Interventional", "study_design": "Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).", "phase": "Phase 2", "countries": "United States;Australia;Belgium;Canada;Czech Republic;France;Germany;Lebanon;Lithuania;Netherlands;New Caledonia;Russian Federation;Spain;Sweden;Switzerland;Ukraine;United Kingdom;Australia;Belgium;Canada;Czech Republic;France;Germany;Lebanon;Lithuania;Netherlands;New Caledonia;Russian Federation;Spain;Sweden;Switzerland;Ukraine;United Kingdom;United States;United States;Australia;Belgium;Canada;Czech Republic;France;Germany;Lebanon;Lithuania;Netherlands;New Caledonia;Russian Federation;Spain;Sweden;Switzerland;Ukraine;United Kingdom;Australia;Belgium;Canada;Czech Republic;France;Germany;Lebanon;Lithuania;Netherlands;New Caledonia;Russian Federation;Spain;Sweden;Switzerland;Ukraine;United Kingdom;United States;United States;Australia;Belgium;Canada;Czech Republic;France;Germany;Lebanon;Lithuania;Netherlands;New Caledonia;Russian Federation;Spain;Sweden;Switzerland;Ukraine;United Kingdom;Australia;Belgium;Canada;Czech Republic;France;Germany;Lebanon;Lithuania;Netherlands;New Caledonia;Russian Federation;Spain;Sweden;Switzerland;Ukraine;United Kingdom;United States;United States;Australia;Belgium;Canada;Czech Republic;France;Germany;Lebanon;Lithuania;Netherlands;New Caledonia;Russian Federation;Spain;Sweden;Switzerland;Ukraine;United Kingdom;Australia;Belgium;Canada;Czech Republic;France;Germany;Lebanon;Lithuania;Netherlands;New Caledonia;Russian Federation;Spain;Sweden;Switzerland;Ukraine;United Kingdom;United States;United States;Australia;Belgium;Canada;Czech Republic;France;Germany;Lebanon;Lithuania;Netherlands;New Caledonia;Russian Federation;Spain;Sweden;Switzerland;Ukraine;United Kingdom;Australia;Belgium;Canada;Czech Republic;France;Germany;Lebanon;Lithuania;Netherlands;New Caledonia;Russian Federation;Spain;Sweden;Switzerland;Ukraine;United Kingdom;United States", "contact_firstname": "; ; ; ;", "contact_lastname": "Daniel Mikol, MD, PhD;Daniel Mikol, MD, PhD;Daniel Mikol, MD, PhD;Daniel Mikol, MD, PhD;Daniel Mikol, MD, PhD", "contact_address": null, "contact_email": ";;;;", "contact_tel": ";;;;", "contact_affiliation": "EMD Serono;EMD Serono;EMD Serono;EMD Serono;EMD Serono", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - Participation in study 28063.\r<br>\r<br> - Completion of Week 36 visit of the core study 28063.\r<br>\r<br> - Willingness and ability to comply with study procedures for the duration of the study.\r<br>\r<br> - Voluntary provision of written informed consent (including, for the USA, subject\r<br> authorization under the Health Insurance Portability and Accountability Act (HIPAA)),\r<br> given before any study-related procedure that is not part of normal medical care and\r<br> with the understanding that the subject may withdraw consent at any time without\r<br> prejudice to his or her future medical care.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Premature discontinuation of core study 28063.\r<br>\r<br> - Subjects who meet criteria listed below will receive IMP in study 28851:\r<br>\r<br> - Subjects who are eligible for participation in extension study 28851 but do not\r<br> meet these criteria will not be treated with IMP but will undergo scheduled\r<br> visits, irrespective of their treatment.\r<br>\r<br> - All subjects must satisfy the following criteria before Extension Study Day 1 (D1-EXT;\r<br> defined as the first day of dosing in the extension study) to be eligible for\r<br> treatment with IMP:\r<br>\r<br> - Eligibility for participation in extension study 28851.\r<br>\r<br> - For women of childbearing potential, a negative urine pregnancy test at\r<br> eligibility assessment.\r<br>\r<br> - Female subjects of childbearing potential must be willing to avoid pregnancy by\r<br> using an adequate method of contraception for four (4) weeks before the first\r<br> dose administered within the extension study, during the study and for twelve\r<br> (12) weeks after the last dose of trial medication. Adequate contraception is\r<br> defined as two barrier methods, or one barrier method with spermicide, or an\r<br> intrauterine device, or use of a combined oral female hormonal contraceptive (or\r<br> the definitions requested by health authorities and locally amended in the core\r<br> study 28063). For the purposes of this trial, women of childbearing potential are\r<br> defined as: \"All female subjects after puberty unless they are post-menopausal\r<br> for at least two years or are surgically sterile\" (For Germany Only: Female\r<br> subjects of childbearing potential must be willing to avoid pregnancy by using\r<br> highly effective methods of contraception for approximately four (4) weeks prior\r<br> to D1-EXT, during and for twelve (12) weeks after the last dose of trial\r<br> medication. This requirement does not apply to surgically sterile subjects or to\r<br> subjects who are postmenopausal for at least 2 years. Highly effective\r<br> contraception is defined as any method or combination of methods which result in\r<br> a low failure rate (i.e. less than (<) 1% per year) when used consistently and\r<br> correctly, such as implants, injectables, combined oral contraceptives, sexual\r<br> abstinence, vasectomized partner, 2 barrier methods, or 1 barrier method with\r<br> spermicide)\r<br>\r<br> - Willingness and ability to comply with study procedures for the duration of the study.\r<br>\r<br> - To be eligible for treatment with investigational medicinal product (IMP) in study\r<br> 28851, the subjects must not meet any of the following criteria:\r<br>\r<br> - Non-eligibility for participation in extension study 28851 (premature discontinuation\r<br> of core study 28063).\r<br>\r<br> - Major protocol violation or non-compliance in the core study.\r<br>\r<br> - Use of prohibited immunomodulatory / immunosuppressive therapies\r<br>\r<br> - Serum immunoglobulin G (IgG) level <3 gram per liter (g/L) if the subject received\r<br> atacicept in the core study, or serum IgG level <6 g/L if the subject received placebo\r<br> in the core study (to protect the blinding of the core study, the IgG level will be\r<br> communicated to the treating physician only if it is too low for extension study\r<br> participation and only after all Week 36 assessments performed within the core study\r<br> have been completed).\r<br>\r<br> - Any condition, including laboratory findings that, in the opinion of the Investigator,\r<br> constitutes a risk or a contraindication for participation in the extension study, or\r<br> that could interfere with the study objectives, conduct or evaluation.\r<br>\r<br> - Known active clinically significant acute or chronic infection, or any major episode\r<br> of infection requiring hospitalization or treatment with parenteral anti-infectives.\r<br>\r<br> - Investigator judgement that treatment of the subject with atacicept in the extension\r<br> study is not appropriate.\r<br>\r<br> - Aspartate aminotransferase (AST), or alanine aminotransferase (ALT), or alkaline\r<br> phosphatase (AP) level greater than (>)2.5 x upper limit of normal (ULN), or total\r<br> bilirubin >1.5 x ULN at eligibility assessment.\r<br>\r<br> - Clinically significant abnormality in any hematological test (e.g. hemoglobin <100 g/L\r<br> (6.21 millimoles per liter [mmol/L]), white blood cells <3 x 10^9 per liter (/L),\r<br> platelets <100 x 10^9/L) at eligibility assessment.\r<br>\r<br> - Clinically significant abnormality on electrocardiogram (ECG) performed at eligibility\r<br> assessment.\r<br>\r<br> - Presence of uncontrolled or New York Health Association (NYHA) class 3 or 4 congestive\r<br> heart failure at Week 36 of the core study.\r<br>\r<br> - Moderate to severe renal impairment (creatinine clearance <50 milliliter per minute\r<br> (mL/min) according to Cockcroft-Gault equation).\r<br>\r<br> - Allergy or hypersensitivity to gadolinium (Gd).\r<br>\r<br> - Allergy or hypersensitivity to atacicept or to any of the components of the formulated\r<br> atacicept.\r<br>\r<br> - Diagnosis or family history of Creutzfeldt-Jakob disease (CJD).\r<br> ;\r<br> Inclusion Criteria:\r<br>\r<br> - Participation in study 28063.\r<br>\r<br> - Completion of Week 36 visit of the core study 28063.\r<br>\r<br> - Willingness and ability to comply with study procedures for the duration of the study.\r<br>\r<br> - Voluntary provision of written informed consent (including, for the USA, subject\r<br> authorization under the Health Insurance Portability and Accountability Act (HIPAA)),\r<br> given before any study-related procedure that is not part of normal medical care and\r<br> with the understanding that the subject may withdraw consent at any time without\r<br> prejudice to his or her future medical care.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Premature discontinuation of core study 28063.\r<br>\r<br> - Subjects who meet criteria listed below will receive IMP in study 28851:\r<br>\r<br> - Subjects who are eligible for participation in extension study 28851 but do not\r<br> meet these criteria will not be treated with IMP but will undergo scheduled\r<br> visits, irrespective of their treatment.\r<br>\r<br> - All subjects must satisfy the following criteria before Extension Study Day 1 (D1-EXT;\r<br> defined as the first day of dosing in the extension study) to be eligible for\r<br> treatment with IMP:\r<br>\r<br> - Eligibility for participation in extension study 28851.\r<br>\r<br> - For women of childbearing potential, a negative urine pregnancy test at\r<br> eligibility assessment.\r<br>\r<br> - Female subjects of childbearing potential must be willing to avoid pregnancy by\r<br> using an adequate method of contraception for four (4) weeks before the first\r<br> dose administered within the extension study, during the study and for twelve\r<br> (12) weeks after the last dose of trial medication. Adequate contraception is\r<br> defined as two barrier methods, or one barrier method with spermicide, or an\r<br> intrauterine device, or use of a combined oral female hormonal contraceptive (or\r<br> the definitions requested by health authorities and locally amended in the core\r<br> study 28063). For the purposes of this trial, women of childbearing potential are\r<br> defined as: \"All female subjects after puberty unless they are post-menopausal\r<br> for at least two years or are surgically sterile\" (For Germany Only: Female\r<br> subjects of childbearing potential must be willing to avoid pregnancy by using\r<br> highly effective methods of contraception for approximately four (4) weeks prior\r<br> to D1-EXT, during and for twelve (12) weeks after the last dose of trial\r<br> medication. This requirement does not apply to surgically sterile subjects or to\r<br> subjects who are postmenopausal for at least 2 years. Highly effective\r<br> contraception is defined as any method or combination of methods which result in\r<br> a low failure rate (i.e. less than (<) 1% per year) when used consistently and\r<br> correctly, such as implants, injectables, combined oral contraceptives, sexual\r<br> abstinence, vasectomized partner, 2 barrier methods, or 1 barrier method with\r<br> spermicide)\r<br>\r<br> - Willingness and ability to comply with study procedures for the duration of the study.\r<br>\r<br> - To be eligible for treatment with investigational medicinal product (IMP) in study\r<br> 28851, the subjects must not meet any of the following criteria:\r<br>\r<br> - Non-eligibility for participation in extension study 28851 (premature discontinuation\r<br> of core study 28063).\r<br>\r<br> - Major protocol violation or non-compliance in the core study.\r<br>\r<br> - Use of prohibited immunomodulatory / immunosuppressive therapies\r<br>\r<br> - Serum immunoglobulin G (IgG) level <3 gram per liter (g/L) if the subject received\r<br> atacicept in the core study, or serum IgG level <6 g/L if the subject received placebo\r<br> in the core study (to protect the blinding of the core study, the IgG level will be\r<br> communicated to the treating physician only if it is too low for extension study\r<br> participation and only after all Week 36 assessments performed within the core study\r<br> have been completed).\r<br>\r<br> - Any condition, including laboratory findings that, in the opinion of the Investigator,\r<br> constitutes a risk or a contraindication for participation in the extension study, or\r<br> that could interfere with the study objectives, conduct or evaluation.\r<br>\r<br> - Known active clinically significant acute or chronic infection, or any major episode\r<br> of infection requiring hospitalization or treatment with parenteral anti-infectives.\r<br>\r<br> - Investigator judgement that treatment of the subject with atacicept in the extension\r<br> study is not appropriate.\r<br>\r<br> - Aspartate aminotransferase (AST), or alanine aminotransferase (ALT), or alkaline\r<br> phosphatase (AP) level greater than (>)2.5 x upper limit of normal (ULN), or total\r<br> bilirubin >1.5 x ULN at eligibility assessment.\r<br>\r<br> - Clinically significant abnormality in any hematological test (e.g. hemoglobin <100 g/L\r<br> (6.21 millimoles per liter [mmol/L]), white blood cells <3 x 10^9 per liter (/L),\r<br> platelets <100 x 10^9/L) at eligibility assessment.\r<br>\r<br> - Clinically significant abnormality on electrocardiogram (ECG) performed at eligibility\r<br> assessment.\r<br>\r<br> - Presence of uncontrolled or New York Health Association (NYHA) class 3 or 4 congestive\r<br> heart failure at Week 36 of the core study.\r<br>\r<br> - Moderate to severe renal impairment (creatinine clearance <50 milliliter per minute\r<br> (mL/min) according to Cockcroft-Gault equation).\r<br>\r<br> - Allergy or hypersensitivity to gadolinium (Gd).\r<br>\r<br> - Allergy or hypersensitivity to atacicept or to any of the components of the formulated\r<br> atacicept.\r<br>\r<br> - Diagnosis or family history of Creutzfeldt-Jakob disease (CJD).\r<br> ;\r<br> Inclusion Criteria:\r<br>\r<br> - Participation in study 28063.\r<br>\r<br> - Completion of Week 36 visit of the core study 28063.\r<br>\r<br> - Willingness and ability to comply with study procedures for the duration of the study.\r<br>\r<br> - Voluntary provision of written informed consent (including, for the USA, subject\r<br> authorization under the Health Insurance Portability and Accountability Act (HIPAA)),\r<br> given before any study-related procedure that is not part of normal medical care and\r<br> with the understanding that the subject may withdraw consent at any time without\r<br> prejudice to his or her future medical care.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Premature discontinuation of core study 28063.\r<br>\r<br> - Subjects who meet criteria listed below will receive IMP in study 28851:\r<br>\r<br> - Subjects who are eligible for participation in extension study 28851 but do not\r<br> meet these criteria will not be treated with IMP but will undergo scheduled\r<br> visits, irrespective of their treatment.\r<br>\r<br> - All subjects must satisfy the following criteria before Extension Study Day 1 (D1-EXT;\r<br> defined as the first day of dosing in the extension study) to be eligible for\r<br> treatment with IMP:\r<br>\r<br> - Eligibility for participation in extension study 28851.\r<br>\r<br> - For women of childbearing potential, a negative urine pregnancy test at\r<br> eligibility assessment.\r<br>\r<br> - Female subjects of childbearing potential must be willing to avoid pregnancy by\r<br> using an adequate method of contraception for four (4) weeks before the first\r<br> dose administered within the extension study, during the study and for twelve\r<br> (12) weeks after the last dose of trial medication. Adequate contraception is\r<br> defined as two barrier methods, or one barrier method with spermicide, or an\r<br> intrauterine device, or use of a combined oral female hormonal contraceptive (or\r<br> the definitions requested by health authorities and locally amended in the core\r<br> study 28063). For the purposes of this trial, women of childbearing potential are\r<br> defined as: \"All female subjects after puberty unless they are post-menopausal\r<br> for at least two years or are surgically sterile\" (For Germany Only: Female\r<br> subjects of childbearing potential must be willing to avoid pregnancy by using\r<br> highly effective methods of contraception for approximately four (4) weeks prior\r<br> to D1-EXT, during and for twelve (12) weeks after the last dose of trial\r<br> medication. This requirement does not apply to surgically sterile subjects or to\r<br> subjects who are postmenopausal for at least 2 years. Highly effective\r<br> contraception is defined as any method or combination of methods which result in\r<br> a low failure rate (i.e. less than (<) 1% per year) when used consistently and\r<br> correctly, such as implants, injectables, combined oral contraceptives, sexual\r<br> abstinence, vasectomized partner, 2 barrier methods, or 1 barrier method with\r<br> spermicide)\r<br>\r<br> - Willingness and ability to comply with study procedures for the duration of the study.\r<br>\r<br> - To be eligible for treatment with investigational medicinal product (IMP) in study\r<br> 28851, the subjects must not meet any of the following criteria:\r<br>\r<br> - Non-eligibility for participation in extension study 28851 (premature discontinuation\r<br> of core study 28063).\r<br>\r<br> - Major protocol violation or non-compliance in the core study.\r<br>\r<br> - Use of prohibited immunomodulatory / immunosuppressive therapies\r<br>\r<br> - Serum immunoglobulin G (IgG) level <3 gram per liter (g/L) if the subject received\r<br> atacicept in the core study, or serum IgG level <6 g/L if the subject received placebo\r<br> in the core study (to protect the blinding of the core study, the IgG level will be\r<br> communicated to the treating physician only if it is too low for extension study\r<br> participation and only after all Week 36 assessments performed within the core study\r<br> have been completed).\r<br>\r<br> - Any condition, including laboratory findings that, in the opinion of the Investigator,\r<br> constitutes a risk or a contraindication for participation in the extension study, or\r<br> that could interfere with the study objectives, conduct or evaluation.\r<br>\r<br> - Known active clinically significant acute or chronic infection, or any major episode\r<br> of infection requiring hospitalization or treatment with parenteral anti-infectives.\r<br>\r<br> - Investigator judgement that treatment of the subject with atacicept in the extension\r<br> study is not appropriate.\r<br>\r<br> - Aspartate aminotransferase (AST), or alanine aminotransferase (ALT), or alkaline\r<br> phosphatase (AP) level greater than (>)2.5 x upper limit of normal (ULN), or total\r<br> bilirubin >1.5 x ULN at eligibility assessment.\r<br>\r<br> - Clinically significant abnormality in any hematological test (e.g. hemoglobin <100 g/L\r<br> (6.21 millimoles per liter [mmol/L]), white blood cells <3 x 10^9 per liter (/L),\r<br> platelets <100 x 10^9/L) at eligibility assessment.\r<br>\r<br> - Clinically significant abnormality on electrocardiogram (ECG) performed at eligibility\r<br> assessment.\r<br>\r<br> - Presence of uncontrolled or New York Health Association (NYHA) class 3 or 4 congestive\r<br> heart failure at Week 36 of the core study.\r<br>\r<br> - Moderate to severe renal impairment (creatinine clearance <50 milliliter per minute\r<br> (mL/min) according to Cockcroft-Gault equation).\r<br>\r<br> - Allergy or hypersensitivity to gadolinium (Gd).\r<br>\r<br> - Allergy or hypersensitivity to atacicept or to any of the components of the formulated\r<br> atacicept.\r<br>\r<br> - Diagnosis or family history of Creutzfeldt-Jakob disease (CJD).\r<br> ;\r<br> Inclusion Criteria:\r<br>\r<br> - Participation in study 28063.\r<br>\r<br> - Completion of Week 36 visit of the core study 28063.\r<br>\r<br> - Willingness and ability to comply with study procedures for the duration of the study.\r<br>\r<br> - Voluntary provision of written informed consent (including, for the USA, subject\r<br> authorization under the Health Insurance Portability and Accountability Act (HIPAA)),\r<br> given before any study-related procedure that is not part of normal medical care and\r<br> with the understanding that the subject may withdraw consent at any time without\r<br> prejudice to his or her future medical care.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Premature discontinuation of core study 28063.\r<br>\r<br> - Subjects who meet criteria listed below will receive IMP in study 28851:\r<br>\r<br> - Subjects who are eligible for participation in extension study 28851 but do not\r<br> meet these criteria will not be treated with IMP but will undergo scheduled\r<br> visits, irrespective of their treatment.\r<br>\r<br> - All subjects must satisfy the following criteria before Extension Study Day 1 (D1-EXT;\r<br> defined as the first day of dosing in the extension study) to be eligible for\r<br> treatment with IMP:\r<br>\r<br> - Eligibility for participation in extension study 28851.\r<br>\r<br> - For women of childbearing potential, a negative urine pregnancy test at\r<br> eligibility assessment.\r<br>\r<br> - Female subjects of childbearing potential must be willing to avoid pregnancy by\r<br> using an adequate method of contraception for four (4) weeks before the first\r<br> dose administered within the extension study, during the study and for twelve\r<br> (12) weeks after the last dose of trial medication. Adequate contraception is\r<br> defined as two barrier methods, or one barrier method with spermicide, or an\r<br> intrauterine device, or use of a combined oral female hormonal contraceptive (or\r<br> the definitions requested by health authorities and locally amended in the core\r<br> study 28063). For the purposes of this trial, women of childbearing potential are\r<br> defined as: \"All female subjects after puberty unless they are post-menopausal\r<br> for at least two years or are surgically sterile\" (For Germany Only: Female\r<br> subjects of childbearing potential must be willing to avoid pregnancy by using\r<br> highly effective methods of contraception for approximately four (4) weeks prior\r<br> to D1-EXT, during and for twelve (12) weeks after the last dose of trial\r<br> medication. This requirement does not apply to surgically sterile subjects or to\r<br> subjects who are postmenopausal for at least 2 years. Highly effective\r<br> contraception is defined as any method or combination of methods which result in\r<br> a low failure rate (i.e. less than (<) 1% per year) when used consistently and\r<br> correctly, such as implants, injectables, combined oral contraceptives, sexual\r<br> abstinence, vasectomized partner, 2 barrier methods, or 1 barrier method with\r<br> spermicide)\r<br>\r<br> - Willingness and ability to comply with study procedures for the duration of the study.\r<br>\r<br> - To be eligible for treatment with investigational medicinal product (IMP) in study\r<br> 28851, the subjects must not meet any of the following criteria:\r<br>\r<br> - Non-eligibility for participation in extension study 28851 (premature discontinuation\r<br> of core study 28063).\r<br>\r<br> - Major protocol violation or non-compliance in the core study.\r<br>\r<br> - Use of prohibited immunomodulatory / immunosuppressive therapies\r<br>\r<br> - Serum immunoglobulin G (IgG) level <3 gram per liter (g/L) if the subject received\r<br> atacicept in the core study, or serum IgG level <6 g/L if the subject received placebo\r<br> in the core study (to protect the blinding of the core study, the IgG level will be\r<br> communicated to the treating physician only if it is too low for extension study\r<br> participation and only after all Week 36 assessments performed within the core study\r<br> have been completed).\r<br>\r<br> - Any condition, including laboratory findings that, in the opinion of the Investigator,\r<br> constitutes a risk or a contraindication for participation in the extension study, or\r<br> that could interfere with the study objectives, conduct or evaluation.\r<br>\r<br> - Known active clinically significant acute or chronic infection, or any major episode\r<br> of infection requiring hospitalization or treatment with parenteral anti-infectives.\r<br>\r<br> - Investigator judgement that treatment of the subject with atacicept in the extension\r<br> study is not appropriate.\r<br>\r<br> - Aspartate aminotransferase (AST), or alanine aminotransferase (ALT), or alkaline\r<br> phosphatase (AP) level greater than (>)2.5 x upper limit of normal (ULN), or total\r<br> bilirubin >1.5 x ULN at eligibility assessment.\r<br>\r<br> - Clinically significant abnormality in any hematological test (e.g. hemoglobin <100 g/L\r<br> (6.21 millimoles per liter [mmol/L]), white blood cells <3 x 10^9 per liter (/L),\r<br> platelets <100 x 10^9/L) at eligibility assessment.\r<br>\r<br> - Clinically significant abnormality on electrocardiogram (ECG) performed at eligibility\r<br> assessment.\r<br>\r<br> - Presence of uncontrolled or New York Health Association (NYHA) class 3 or 4 congestive\r<br> heart failure at Week 36 of the core study.\r<br>\r<br> - Moderate to severe renal impairment (creatinine clearance <50 milliliter per minute\r<br> (mL/min) according to Cockcroft-Gault equation).\r<br>\r<br> - Allergy or hypersensitivity to gadolinium (Gd).\r<br>\r<br> - Allergy or hypersensitivity to atacicept or to any of the components of the formulated\r<br> atacicept.\r<br>\r<br> - Diagnosis or family history of Creutzfeldt-Jakob disease (CJD).\r<br>", "exclusion_criteria": null, "condition": "Relapsing Multiple Sclerosis;Relapsing Multiple Sclerosis;Relapsing Multiple Sclerosis;Relapsing Multiple Sclerosis", "intervention": "Drug: Atacicept 25 mg;Drug: Atacicept 75 mg;Drug: Atacicept 150 mg;Drug: Atacicept 150 mg;Drug: Atacicept 25 mg;Drug: Atacicept 75 mg;Drug: Atacicept 150 mg;Drug: Atacicept 150 mg;Drug: Atacicept 25 mg;Drug: Atacicept 75 mg;Drug: Atacicept 150 mg;Drug: Atacicept 150 mg;Drug: Atacicept 25 mg;Drug: Atacicept 75 mg;Drug: Atacicept 150 mg;Drug: Atacicept 150 mg", "primary_outcome": "Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Injection Site Reactions, Infections, and Malignancies by Severity;Change From Baseline in Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP);Change From Baseline in Vital Signs: Pulse Rate;Change From Baseline in Vital Signs: Temperature;Change From Baseline in Electrocardiogram (ECGs);Number of Subjects With Worsened Post Baseline Shift in Immunoglobulin A (IgA), IgG and IgM Levels;Number of Subjects With Positive Neutralizing Antibody (NAb);Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Injection Site Reactions, Infections, and Malignancies by Severity;Change From Baseline in Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP);Change From Baseline in Vital Signs: Pulse Rate;Change From Baseline in Vital Signs: Temperature;Change From Baseline in Electrocardiogram (ECGs);Number of Subjects With Worsened Post Baseline Shift in Immunoglobulin A (IgA), IgG and IgM Levels;Number of Subjects With Positive Neutralizing Antibody (NAb);Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Injection Site Reactions, Infections, and Malignancies by Severity;Change From Baseline in Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP);Change From Baseline in Vital Signs: Pulse Rate;Change From Baseline in Vital Signs: Temperature;Change From Baseline in Electrocardiogram (ECGs);Number of Subjects With Worsened Post Baseline Shift in Immunoglobulin A (IgA), IgG and IgM Levels;Number of Subjects With Positive Neutralizing Antibody (NAb)", "secondary_outcome": "Number of Subjects With Clinical Attacks/Relapses;Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at Week 12;Change in Multiple Sclerosis Functional Composite (MSFC) Score at Week 12;Magnetic Resonance Imaging (MRI) Parameters: Number of T1 Gadolinium (Gd)-Enhancing Lesions Per Subject;Magnetic Resonance Imaging (MRI) Parameters: Volume of T2 Lesions (New or Enlarging T2 Lesions) Per Subject;Concentrations of Free and Total Atacicept;Free B-Lymphocyte Stimulator (BLyS) and Free A Proliferation-Inducing Ligand (APRIL) Serum Concentrations.;Pharmacogenetics/Pharmacogenomics Analysis", "secondary_id": "28851", "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": 3580, "title": "Low Fat Diet and Multiple Sclerosis", "summary": null, "published_date": "2009-02-26T00:00:00Z", "discovery_date": "2023-12-06T18:18:20.417726Z", "link": "http://clinicaltrials.gov/show/NCT00852722", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT00852722" }, "categories": [], "export_date": "2024-04-27T00:00:00Z", "internal_number": "4654684", "last_refreshed_on": "2015-02-19", "scientific_title": "A Randomized, Controlled Study of Diet and Multiple Sclerosis", "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": "Both", "date_enrollement": "2009-02-27", "target_size": "61", "study_type": "Interventional", "study_design": "Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment", "phase": "Phase 1", "countries": "United States", "contact_firstname": "", "contact_lastname": "Vijayshree Yadav, MD", "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": "Oregon Health and Science University", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - Clinical diagnosis of the relapsing-remitting form of MS\r<br>\r<br> - Age 18-70, inclusive\r<br>\r<br> - MS duration of less than 15 years\r<br>\r<br> - May or may not be on disease-modifying therapies for MS, but if on, must be on for\r<br> more than 6 months of continuous therapy\r<br>\r<br> - Should not have diabetes\r<br>\r<br> - Able and willing to follow exercise instructions\r<br>\r<br> - Able and willing to travel to California for 10-day training program (cost covered by\r<br> study)\r<br>\r<br> - Able and willing to travel to Portland, OR for 6 study visits over the 12 month study\r<br> period (cost covered by study)\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - No clinically significant MS exacerbation within 30 days of screening visit\r<br>\r<br> - No systemically administered corticosteroids within 30 days of study entry\r<br>\r<br> - Patient not pregnant or breastfeeding\r<br>\r<br> - Not taking fish oil/flax seed for at least 2 months prior to first visit\r<br>\r<br> - No other significant health programs (e.g. active coronary heart disease, liver\r<br> disease, pulmonary disease) that might increase risk of patient experiencing adverse\r<br> events\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis", "intervention": "Other: Low fat study diet", "primary_outcome": "Number of new MS T2 lesion formation on brain MRI in those randomized to the low fat study diet with that of subjects randomized to follow their regular diet.", "secondary_outcome": "To assess effects of the low fat study diet on clinical activity of MS as by relapse rate and disability progression and on fatigue, depression and quality of life.;To study the effects of the Low Fat Study Diet on serum markers of inflammation;To assess safety and tolerability of the low fat study diet upon 12 months of administration", "secondary_id": "OHSU IRB00004555", "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 } ] }