Trial List
List all clinical trials by discovery date. Accepts regular expressions in search.
GET /trials/
{ "count": 3769, "next": "http://api.gregory-ms.com/trials/?page=2", "previous": null, "results": [ { "trial_id": 3284, "title": "Neural Mobilization on Multiple Sclerosis", "summary": "<b>Conditions</b>: Multiple Sclerosis\n<br /><b>Interventions</b>: Other: neurodynamic mobilization exercise; Other: strengthening exercises\n<br /><b>Sponsors</b>: Kahramanmaras Sutcu Imam University\n<br /><b>Recruiting</b>", "published_date": "2023-12-01T05:00:00Z", "discovery_date": "2023-12-01T14:23:18.150850Z", "link": "https://clinicaltrials.gov/study/NCT06153264?cond=Multiple+Sclerosis", "source": "Clinical Trials.gov", "relevant": null, "identifiers": { "nct": "NCT06153264", "euct": null, "eudract": null }, "categories": [], "export_date": null, "internal_number": null, "last_refreshed_on": null, "scientific_title": null, "primary_sponsor": null, "retrospective_flag": null, "date_registration": null, "source_register": null, "recruitment_status": null, "other_records": null, "inclusion_agemin": null, "inclusion_agemax": null, "inclusion_gender": null, "date_enrollement": null, "target_size": null, "study_type": null, "study_design": null, "phase": null, "countries": null, "contact_firstname": null, "contact_lastname": null, "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": null, "inclusion_criteria": null, "exclusion_criteria": null, "condition": null, "intervention": null, "primary_outcome": null, "secondary_outcome": null, "secondary_id": null, "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": 3283, "title": "HOme-Based Self-management and COgnitive Training CHanges Lives (HOBSCOTCH) - Multiple Sclerosis (MS)", "summary": "<b>Conditions</b>: Multiple Sclerosis; Cognitive Dysfunction; Memory Disorders\n<br /><b>Interventions</b>: Behavioral: HOme-Based Self-management and COgnitive Training CHanges lives (HOBSCOTCH)\n<br /><b>Sponsors</b>: Dartmouth-Hitchcock Medical Center\n<br /><b>Not yet recruiting</b>", "published_date": "2023-11-24T05:00:00Z", "discovery_date": "2023-11-27T14:03:22.142271Z", "link": "https://clinicaltrials.gov/study/NCT06145737?cond=Multiple+Sclerosis", "source": "Clinical Trials.gov", "relevant": null, "identifiers": { "nct": "NCT06145737", "euct": null, "eudract": null }, "categories": [ { "category_id": 18, "category_description": "Search terms: telerehabilitation, physical therapy, virtual reality, gamification, neurostimulation, cognitive training, spasticity, motor control.\n\nSuggested by Alejandro Carrabs", "category_name": "Physical therapy and Telerehabilitation", "category_slug": "physical-therapy-and-telerehabilitation", "category_terms": [ "telerehabilitation", "physical therapy", "virtual reality", "gamification", "neurostimulation", "cognitive training", "spasticity", "motor control" ], "count_of_articles": 160 } ], "export_date": null, "internal_number": null, "last_refreshed_on": null, "scientific_title": null, "primary_sponsor": null, "retrospective_flag": null, "date_registration": null, "source_register": null, "recruitment_status": null, "other_records": null, "inclusion_agemin": null, "inclusion_agemax": null, "inclusion_gender": null, "date_enrollement": null, "target_size": null, "study_type": null, "study_design": null, "phase": null, "countries": null, "contact_firstname": null, "contact_lastname": null, "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": null, "inclusion_criteria": null, "exclusion_criteria": null, "condition": null, "intervention": null, "primary_outcome": null, "secondary_outcome": null, "secondary_id": null, "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": 3282, "title": "Blood Flow Restriction Training in Multiple Sclerosis", "summary": "<b>Conditions</b>: MS\n<br /><b>Interventions</b>: Other: strengthening ex with BFR training; Other: strengthening ex\n<br /><b>Sponsors</b>: Cairo University\n<br /><b>Recruiting</b>", "published_date": "2023-11-22T05:00:00Z", "discovery_date": "2023-11-22T13:43:10.591844Z", "link": "https://clinicaltrials.gov/study/NCT06143930?cond=Multiple+Sclerosis", "source": "Clinical Trials.gov", "relevant": null, "identifiers": { "nct": "NCT06143930", "euct": null, "eudract": null }, "categories": [], "export_date": null, "internal_number": null, "last_refreshed_on": null, "scientific_title": null, "primary_sponsor": null, "retrospective_flag": null, "date_registration": null, "source_register": null, "recruitment_status": null, "other_records": null, "inclusion_agemin": null, "inclusion_agemax": null, "inclusion_gender": null, "date_enrollement": null, "target_size": null, "study_type": null, "study_design": null, "phase": null, "countries": null, "contact_firstname": null, "contact_lastname": null, "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": null, "inclusion_criteria": null, "exclusion_criteria": null, "condition": null, "intervention": null, "primary_outcome": null, "secondary_outcome": null, "secondary_id": null, "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": 3281, "title": "A Study Evaluating the Presence and Concentration of BRIUMVI™ (Ublituximab) in Breast Milk", "summary": "<b>Conditions</b>: Relapsing Multiple Sclerosis\n<br /><b>Interventions</b>: Other: No intervention\n<br /><b>Sponsors</b>: TG Therapeutics, Inc.\n<br /><b>Not yet recruiting</b>", "published_date": "2023-11-22T05:00:00Z", "discovery_date": "2023-11-22T13:43:10.579433Z", "link": "https://clinicaltrials.gov/study/NCT06143514?cond=Multiple+Sclerosis", "source": "Clinical Trials.gov", "relevant": null, "identifiers": { "nct": "NCT06143514", "euct": null, "eudract": null }, "categories": [ { "category_id": 34, "category_description": "Briumvi is a medicine for treating adults with relapsing forms of multiple sclerosis (a disease of the brain and spinal cord in which inflammation destroys the protective covering around nerves and damages the nerves), where the patient has flare-ups (relapses) followed by periods with milder or no symptoms. It is used in patients with active disease, which means that they have relapses and/or signs of active inflammation on scans.", "category_name": "Ublituximab", "category_slug": "ublituximab", "category_terms": [ "ublituximab", "briumvi" ], "count_of_articles": 10 } ], "export_date": null, "internal_number": null, "last_refreshed_on": null, "scientific_title": null, "primary_sponsor": null, "retrospective_flag": null, "date_registration": null, "source_register": null, "recruitment_status": null, "other_records": null, "inclusion_agemin": null, "inclusion_agemax": null, "inclusion_gender": null, "date_enrollement": null, "target_size": null, "study_type": null, "study_design": null, "phase": null, "countries": null, "contact_firstname": null, "contact_lastname": null, "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": null, "inclusion_criteria": null, "exclusion_criteria": null, "condition": null, "intervention": null, "primary_outcome": null, "secondary_outcome": null, "secondary_id": null, "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": 3280, "title": "Effect of TTNS and PNS on Neurogenic Overactive Bladder Symptoms in Female Patients With Multiple Sclerosis.", "summary": "<b>Conditions</b>: Multiple Sclerosis; Overactive Bladder Syndrome\n<br /><b>Interventions</b>: Device: TTNS (Transcutaneous tibial nerve stimulation); Device: PNS (Parasacral nerve stimulation); Device: Sham stimulation; Behavioral: Behavioral treatment\n<br /><b>Sponsors</b>: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization; Marmara University\n<br /><b>Not yet recruiting</b>", "published_date": "2023-11-22T05:00:00Z", "discovery_date": "2023-11-22T13:43:10.557401Z", "link": "https://clinicaltrials.gov/study/NCT06143397?cond=Multiple+Sclerosis", "source": "Clinical Trials.gov", "relevant": null, "identifiers": { "nct": "NCT06143397", "euct": null, "eudract": null }, "categories": [], "export_date": null, "internal_number": null, "last_refreshed_on": null, "scientific_title": null, "primary_sponsor": null, "retrospective_flag": null, "date_registration": null, "source_register": null, "recruitment_status": null, "other_records": null, "inclusion_agemin": null, "inclusion_agemax": null, "inclusion_gender": null, "date_enrollement": null, "target_size": null, "study_type": null, "study_design": null, "phase": null, "countries": null, "contact_firstname": null, "contact_lastname": null, "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": null, "inclusion_criteria": null, "exclusion_criteria": null, "condition": null, "intervention": null, "primary_outcome": null, "secondary_outcome": null, "secondary_id": null, "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": 1293, "title": "Efficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sclerosis", "summary": "<b>Conditions</b>: Multiple Sclerosis\n<br /><b>Interventions</b>: Drug: Frexalimab; Drug: Teriflunomide; Drug: Placebo infusion; Drug: Placebo tablet; Drug: MRI contrast-enhancing agents; Drug: Cholestyramine; Drug: Activated charcoal\n<br /><b>Sponsors</b>: Sanofi\n<br /><b>Not yet recruiting</b>", "published_date": "2023-11-21T05:00:00Z", "discovery_date": "2023-11-21T14:03:16.587594Z", "link": "https://clinicaltrials.gov/study/NCT06141473?cond=Multiple+Sclerosis", "source": "Clinical Trials.gov", "relevant": null, "identifiers": { "nct": "NCT06141473", "euct": null, "eudract": null }, "categories": [ { "category_id": 41, "category_description": "Sanofi has reported positive new data from a mid-stage study of its investigational anti-CD40L antibody in patients with relapsing multiple sclerosis (MS).\n\nResults from the phase 2 study, being presented at the 2023 Consortium of Multiple Sclerosis Centers annual meeting, demonstrate that frexalimab significantly reduced disease activity in patients with relapsing forms of the disease.\n\nSource: https://www.sanofi.com/en/media-room/press-releases/2023/2023-05-31-05-00-00-2678991", "category_name": "Frexalimab", "category_slug": "frexalimab", "category_terms": [ "frexalimab", "SAR441344" ], "count_of_articles": 1 } ], "export_date": null, "internal_number": null, "last_refreshed_on": null, "scientific_title": null, "primary_sponsor": null, "retrospective_flag": null, "date_registration": null, "source_register": null, "recruitment_status": null, "other_records": null, "inclusion_agemin": null, "inclusion_agemax": null, "inclusion_gender": null, "date_enrollement": null, "target_size": null, "study_type": null, "study_design": null, "phase": null, "countries": null, "contact_firstname": null, "contact_lastname": null, "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": null, "inclusion_criteria": null, "exclusion_criteria": null, "condition": null, "intervention": null, "primary_outcome": null, "secondary_outcome": null, "secondary_id": null, "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": 1292, "title": "Efficacy and Safety Study of Frexalimab (SAR441344) in Adults With Nonrelapsing Secondary Progressive Multiple Sclerosis", "summary": "<b>Conditions</b>: Multiple Sclerosis\n<br /><b>Interventions</b>: Drug: Frexalimab; Drug: Placebo; Drug: MRI contrast-enhancing agents\n<br /><b>Sponsors</b>: Sanofi\n<br /><b>Not yet recruiting</b>", "published_date": "2023-11-21T05:00:00Z", "discovery_date": "2023-11-21T14:03:16.576733Z", "link": "https://clinicaltrials.gov/study/NCT06141486?cond=Multiple+Sclerosis", "source": "Clinical Trials.gov", "relevant": null, "identifiers": { "nct": "NCT06141486", "euct": null, "eudract": null }, "categories": [ { "category_id": 41, "category_description": "Sanofi has reported positive new data from a mid-stage study of its investigational anti-CD40L antibody in patients with relapsing multiple sclerosis (MS).\n\nResults from the phase 2 study, being presented at the 2023 Consortium of Multiple Sclerosis Centers annual meeting, demonstrate that frexalimab significantly reduced disease activity in patients with relapsing forms of the disease.\n\nSource: https://www.sanofi.com/en/media-room/press-releases/2023/2023-05-31-05-00-00-2678991", "category_name": "Frexalimab", "category_slug": "frexalimab", "category_terms": [ "frexalimab", "SAR441344" ], "count_of_articles": 1 } ], "export_date": null, "internal_number": null, "last_refreshed_on": null, "scientific_title": null, "primary_sponsor": null, "retrospective_flag": null, "date_registration": null, "source_register": null, "recruitment_status": null, "other_records": null, "inclusion_agemin": null, "inclusion_agemax": null, "inclusion_gender": null, "date_enrollement": null, "target_size": null, "study_type": null, "study_design": null, "phase": null, "countries": null, "contact_firstname": null, "contact_lastname": null, "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": null, "inclusion_criteria": null, "exclusion_criteria": null, "condition": null, "intervention": null, "primary_outcome": null, "secondary_outcome": null, "secondary_id": null, "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": 1271, "title": "A Phase 2 double blind, randomized, placebo controlled study evaluating the effect of SAR443820 on serum neurofilament levels in participants with multiple sclerosis, followed by an open label long...", "summary": "<p>EudraCT Number: 2022-000049-34<br />Sponsor Protocol Number: ACT16753<br />Sponsor Name: SANOFI-AVENTIS RECHERCHE E DEVELOPPEMENT<br />Start Date: 2022-09-29<br />Medical condition: Multiple sclerosis<br />Disease: <br />Version: 20.1<br />SOC Term: 10029205 - Nervous system disorders<br />Classification Code: 10028245<br />Term: Multiple sclerosis<br />Level: PT<br /><br />Population Age: Adults<br />Gender: Male, Female<br />Trial Protocol: <a href=\"https://www.clinicaltrialsregister.eu/ctr-search/trial/2022-000049-34/IT\">IT</a> (Ongoing), <a href=\"https://www.clinicaltrialsregister.eu/ctr-search/trial/2022-000049-34/ES\">ES</a> (Ongoing), <a href=\"https://www.clinicaltrialsregister.eu/ctr-search/trial/2022-000049-34/PL\">PL</a> (Ongoing), <a href=\"https://www.clinicaltrialsregister.eu/ctr-search/trial/2022-000049-34/DE\">DE</a> (Ongoing), <a href=\"https://www.clinicaltrialsregister.eu/ctr-search/trial/2022-000049-34/GR\">GR</a> (Prematurely Ended), <a href=\"https://www.clinicaltrialsregister.eu/ctr-search/trial/2022-000049-34/BG\">BG</a> (Ongoing)</p>", "published_date": null, "discovery_date": "2023-11-21T12:43:16.754060Z", "link": "https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number%3A2022-000049-34", "source": "European Clinical Trials Register", "relevant": null, "identifiers": { "nct": null, "euct": "EUCT2022-000049-34", "eudract": "EUDRACT2022-000049-34" }, "categories": [], "export_date": null, "internal_number": null, "last_refreshed_on": null, "scientific_title": null, "primary_sponsor": null, "retrospective_flag": null, "date_registration": null, "source_register": null, "recruitment_status": null, "other_records": null, "inclusion_agemin": null, "inclusion_agemax": null, "inclusion_gender": null, "date_enrollement": null, "target_size": null, "study_type": null, "study_design": null, "phase": null, "countries": null, "contact_firstname": null, "contact_lastname": null, "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": null, "inclusion_criteria": null, "exclusion_criteria": null, "condition": null, "intervention": null, "primary_outcome": null, "secondary_outcome": null, "secondary_id": null, "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": 3049, "title": "Alternative Treatment Paradigm for Natalizumab Trial", "summary": null, "published_date": "2012-04-09T00:00:00Z", "discovery_date": "2023-11-21T00:00:00Z", "link": "https://clinicaltrials.gov/show/NCT01710228", "source": null, "relevant": null, "identifiers": { "nct": "NCT01710228" }, "categories": [ { "category_id": 7, "category_description": "", "category_name": "Natalizumab", "category_slug": "natalizumab", "category_terms": [ "natalizumab", "tysabri" ], "count_of_articles": 279 } ], "export_date": "2023-11-21T00:00:00Z", "internal_number": "5926328", "last_refreshed_on": "2017-01-09", "scientific_title": "Alternative Treatment Paradigm for Natalizumab Trial", "primary_sponsor": "University of Texas Southwestern Medical Center", "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": "Both", "date_enrollement": "2013-07-21", "target_size": "0", "study_type": "Interventional", "study_design": "Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment", "phase": "Phase 2", "countries": "United States", "contact_firstname": "", "contact_lastname": "Olaf Stuve, MD PhD", "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": "University of Texas Southwestern Medical Center", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> 1. Age between 18 and 60 years, inclusive.\r<br>\r<br> 2. Diagnosis of relapsing forms of MS using revised McDonald Criteria 11.\r<br>\r<br> 3. Patients who have not failed GA therapy.\r<br>\r<br> 4. EDSS 0 - 5.5 (Functional system changes in cerebral (or mental) functions and in\r<br> bowel and bladder functions not used in determining EDSS for protocol eligibility).\r<br>\r<br> 5. No more than two relapses in the 12 months prior to initiating natalizumab therapy.\r<br>\r<br> 6. A minimum of 9 doses of natalizumab prior to randomization.\r<br>\r<br> 7. Disease controlled under natalizumab treatment demonstrated by the absence of\r<br> relapses (no relapse in the 9 months prior to randomization)\r<br>\r<br> 8. Understood and signed written informed consent, obtained prior to the study subject\r<br> undergoing any study-related procedure, including screening tests.\r<br>\r<br> Enrollment of patients in the TOUCHTM program at United States of America study sites as\r<br> long as required: According to guidelines established by the Department of Health & Human\r<br> Services, natalizumab is currently only available under a special restricted distribution\r<br> program called TOUCHTM within the United States\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> 1. Known hypersensitivity to GA.\r<br>\r<br> 2. Initiation of new immunosuppressant treatment after the subject becomes\r<br> protocol-eligible (except for corticosteroids) or enrollment in a concurrent trial\r<br> unless an exception is granted following consideration by the MS Review Panel.\r<br>\r<br> 3. Patients who were treated with GA before natalizumab therapy and failed GA therapy.\r<br>\r<br> 4. Subjects with any history of cytopenia consistent with the diagnosis of\r<br> myelodysplastic syndrome (MDS).\r<br>\r<br> 5. Active hepatitis B or hepatitis C infection or evidence of cirrhosis.\r<br>\r<br> 6. HIV positivity.\r<br>\r<br> 7. Uncontrolled diabetes mellitus defined as HbA1c > 8% and/or requiring intensive\r<br> management.\r<br>\r<br> 8. Uncontrolled viral, fungal, or bacterial infection (excluding asymptomatic\r<br> bacteriuria).\r<br>\r<br> 9. Any condition that, in the opinion of the investigators, would jeopardize the ability\r<br> of the subject to tolerate treatment with GA.\r<br>\r<br> 10. Prior history of malignancy, except localized basal cell or squamous skin cancer.\r<br> Other malignancies for which the subject is judged to be cured by the administered\r<br> therapy, such as head and neck cancer, or breast cancer, will be considered on an\r<br> individual basis by the Study's MS review panel.\r<br>\r<br> 11. Positive pregnancy test or inability or unwillingness to use effective means of birth\r<br> control. Effective birth control is defined as:\r<br>\r<br> 1. Refraining from all acts of vaginal intercourse (abstinence),\r<br>\r<br> 2. Consistent use of birth control pills,\r<br>\r<br> 3. Injectable birth control methods (®Depo-Provera, ®Norplant),\r<br>\r<br> 4. Tubal sterilization or male partner who has undergone vasectomy,\r<br>\r<br> 5. Placement of an IUD (intrauterine device)\r<br>\r<br> 6. Use, with every act of intercourse, of a diaphragm with contraceptive jelly\r<br> and/or condoms with contraceptive foam.\r<br>\r<br> 12. Presence of metallic objects implanted in the body that would preclude the ability of\r<br> the subject to safely have MRI exams.\r<br>\r<br> 13. Psychiatric illness, mental deficiency, or cognitive dysfunction making compliance\r<br> with treatment or informed consent impossible.\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis (MS)", "intervention": "Drug: methylprednisolone", "primary_outcome": "annualized relapse rate", "secondary_outcome": "restoration of immune homeostasis - evaluated by regular brain MRI with contrast at baseline, month6 and month 12 of the study", "secondary_id": "STU092011-077", "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": 1984, "title": "Fecal Microbiota Transplantation (FMT) of FMP30 in Relapsing-Remitting Multiple Sclerosis", "summary": null, "published_date": "2018-07-06T00:00:00Z", "discovery_date": "2023-11-21T00:00:00Z", "link": "https://clinicaltrials.gov/show/NCT03594487", "source": null, "relevant": null, "identifiers": { "nct": "NCT03594487" }, "categories": [], "export_date": "2023-11-21T00:00:00Z", "internal_number": "13161411", "last_refreshed_on": "2023-07-10", "scientific_title": "Fecal Microbiota Transplantation (FMT) of FMP30 in Relapsing-Remitting Multiple Sclerosis: A Phase 1b Clinical Trial to Evaluate Feasibility, Safety, Tolerability and Effects on Immune Function", "primary_sponsor": "Jeffrey Gelfand", "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": "2018-11-16", "target_size": "30", "study_type": "Interventional", "study_design": "Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).", "phase": "Phase 1", "countries": "United States", "contact_firstname": "", "contact_lastname": "Jeffrey Gelfand", "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": "UCSF Multiple Sclerosis Center", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> 1. Age 18-60 inclusive (at time of screening).\r<br>\r<br> 2. Diagnosis of relapsing-remitting multiple sclerosis (MS) by International Panel\r<br> McDonald Criteria (2010)(1) incorporating 2017 revisions which reclassify select\r<br> high-risk Clinically Isolated Syndromes under 2010 criteria as RRMS under 2017\r<br> criteria, and Lublin criteria (2014)(2).\r<br>\r<br> 3. Recent documented MS disease activity, defined as at least 1 clinical relapse within\r<br> the past 1 year prior to baseline OR 2 clinical relapses in the past 2 years prior to\r<br> baseline OR at least 1 new T2/FLAIR lesion on brain or spine MRI OR at least 1\r<br> gadolinium enhancing lesion on brain or spine MRI in the past 1 year prior to\r<br> baseline.\r<br>\r<br> 4. Expanded Disability Status Scale (EDSS) less than or equal to 6.0; EDSS 5.5 or less if\r<br> MS disease duration is greater than 15 years (no other disease duration restriction).\r<br>\r<br> 5. Must have positive serology for Epstein-Barr Virus (EBV) (IgG anti-EBNA positive) at\r<br> screening, indicating prior exposure.\r<br>\r<br> 6. No prior MS disease modifying therapy or a 12 week washout period for subjects on\r<br> glatiramer acetate or interferon-beta therapy.\r<br>\r<br> 7. At least 4 weeks from baseline since last use of IV or oral glucocorticoids Protocol:\r<br> MS-BIOME Study.\r<br>\r<br> 8. Agree to maintain a stable diet during the course of the study (over the counter\r<br> probiotics are allowable).\r<br>\r<br> 9. Premenopausal women and women <12 months after the onset of menopause must have a\r<br> negative serum pregnancy test unless they have undergone surgical sterilization.\r<br>\r<br> 10. Female subjects of childbearing potential who are sexually active with a\r<br> non-sterilized male partner must agree to use a highly effective method of\r<br> contraception; non-sterilized male subjects who are sexually active with a female\r<br> partner of childbearing potential must agree to use a highly effective method of\r<br> contraception.\r<br>\r<br> 11. Not actively participating in another interventional MS clinical trial (participation\r<br> in other observational research studies is allowable).\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> 1. Prior use of fingolimod, dimethyl fumarate, teriflunomide, natalizumab, alemtuzumab,\r<br> mitoxantrone, cyclophosphamide, rituximab, ocrelizumab, daclizumab, methotrexate,\r<br> azathioprine, mycophenolate mofetil, cyclosporine, leflunomide or induction\r<br> chemotherapy.\r<br>\r<br> 2. No use of diuretics like furosemide (Lasix) 1 week before the first dose oral\r<br> antibiotics. The use of hydrochlorothiazide (HCTZ) for hypertension at a dose < 50\r<br> mg/day is allowable.\r<br>\r<br> 3. Progressive MS by Lublin criteria (2014).\r<br>\r<br> 4. No oral or IV antibiotics within 8 weeks of screening and 12 weeks of scheduled of the\r<br> planned FMT procedure if in the FMT arm or first stool collection if in control arm\r<br> (note that topical, otic, ocular antibiotics are specifically allowable which is\r<br> consistent with the IMSMS.org protocol for collaborative gut microbiome research in\r<br> MS).\r<br>\r<br> 5. Hypersensitivity or allergy to study antibiotics, conscious sedation medications or\r<br> bowel preparation.\r<br>\r<br> 6. Contraindication to study procedures including MRI, anesthesia (ASA criteria IV and\r<br> V), colonoscopy, phlebotomy.\r<br>\r<br> 7. History of inflammatory bowel disease (Crohn's Disease, Ulcerative Colitis) Protocol:\r<br> MS-BIOME Study.\r<br>\r<br> 8. Active symptomatic C. Difficile infection (colonization is not an exclusion).\r<br>\r<br> 9. Active gastrointestinal condition being investigated (i.e. GI bleeding, colon cancer,\r<br> active GI workup); history of known or suspected toxic megacolon and/or known small\r<br> bowel ileus, major gastrointestinal surgery (e.g. significant bowel resection) within\r<br> 3 months before enrollment (note that this does not include appendectomy or\r<br> cholecystectomy); or history of total colectomy or bariatric surgery.\r<br>\r<br> 10. History of malignancy (except excised cutaneous basal cell carcinoma or squamous cell\r<br> carcinoma which are allowable) including no concurrent induction chemotherapy,\r<br> radiation therapy or biological treatment for active malignancy.\r<br>\r<br> 11. Pregnant or lactating women or intention of getting pregnant during the trial period.\r<br>\r<br> 12. Active infection including untreated latent or active tuberculosis, HIV, hepatitis,\r<br> syphilis or other major active infection.\r<br>\r<br> 13. Known immunodeficiency including CVID.\r<br>\r<br> 14. INR>1.5, Platelets<100, Hemoglobin <8.5, WBC<2.0, Absolute lymphocyte count <0.8,\r<br> Absolute Neutrophil Count <0.5, CD4<200, eGFR<45.\r<br>\r<br> 15. Any condition that in the opinion of the study PI could jeopardize the safety of the\r<br> subject, would make it unlikely for the subject to complete the study or could\r<br> confound the results of the study.\r<br>\r<br> 16. Unable or unwilling to comply with study protocol requirements.\r<br>", "exclusion_criteria": null, "condition": "Relapsing Remitting Multiple Sclerosis", "intervention": "Drug: FMP30 Donor Stool;Procedure: Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool;Other: Observational Control", "primary_outcome": "Subjects who complete the study protocol;Change in fecal microbiota;Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]", "secondary_outcome": "Induction of T regulatory or Th2 cells and/or reduction of Th1 or Th17 cells;Plasma CD19+ B cell count percentages;Plasma CD20+ B cell count percentages;Plasma CD19+ B cell absolute count;Plasma CD20+ B cell absolute count;Measurement of Serum Immunoglobulin Levels;Incidence of new T2/FLAIR lesions;Measurement of T2/FLAIR lesion volume;Number of T2/FLAIR lesions;Total Gadolinium Enhancing Lesions", "secondary_id": "17-23827", "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 } ] }