Trial List
List all clinical trials by discovery date. Accepts regular expressions in search.
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{ "count": 4828, "next": "http://api.gregory-ms.com/trials/?format=api&page=3", "previous": "http://api.gregory-ms.com/trials/?format=api", "results": [ { "trial_id": 4336, "title": "Gait and Balance Impairment in Rare and Very Rare Neurological Diseases", "summary": "<b>Conditions</b>: Multiple Sclerosis; Parkinson Disease; Peripheral Neuropathy; Rare Diseases; Healthy; Healthy Aging\n<br /><b>Interventions</b>: Other: Questionnaires, clinical scales and instrumental tests\n<br /><b>Sponsors</b>: Istituto Auxologico Italiano; IRCCS Istituto Neurologico Carlo Besta\n<br /><b>Recruiting</b>", "published_date": "2024-04-02T04:00:00Z", "discovery_date": "2024-04-15T14:25:44.251397Z", "link": "https://clinicaltrials.gov/study/NCT06343558?cond=Multiple+Sclerosis", "source": "Clinical Trials.gov", "relevant": null, "identifiers": { "nct": "NCT06343558", "euct": null, "eudract": null }, "categories": [], "export_date": "2024-04-15T00:00:00Z", "internal_number": "13879862", "last_refreshed_on": "2024-04-08", "scientific_title": "Gait and Balance Impairment in Rare and Very Rare Neurological Diseases", "primary_sponsor": "Istituto Auxologico Italiano", "retrospective_flag": "No", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "80 Years", "inclusion_gender": "All", "date_enrollement": "2023-05-30", "target_size": "200", "study_type": "Observational [Patient Registry]", "study_design": null, "phase": null, "countries": "Italy", "contact_firstname": "", "contact_lastname": "Antonio Caronni, MD, PhD", "contact_address": null, "contact_email": "[email protected]", "contact_tel": "02 619111", "contact_affiliation": null, "inclusion_criteria": "<br> Inclusion criteria\r<br>\r<br> - Multiple sclerosis, Parkinson's disease, peripheral neuropathy of the lower limbs or\r<br> rare or ultrarare neurological disease (e.g. la Cerebellar Ataxia with Neuropathy and\r<br> Vestibular Areflexia Syndrome - CANVAS, ORPHAcode: 504476; Wilson's disease,\r<br> ORPHAcode: 905)\r<br>\r<br> - undiagnosed neurological disease, i.e. a neurological disease that remains unknown\r<br> after a full diagnostic assessment;\r<br>\r<br> - age > 18 years;\r<br>\r<br> - ability to stand upright with no assistance and no assistive device for > 30 seconds;\r<br>\r<br> - ability to walk without assistance and with no assistive device for > 50 m;\r<br>\r<br> - ability to give their informed consent.\r<br>\r<br> Exclusion criteria\r<br>\r<br> - pregnancy or breastfeeding\r<br>\r<br> - any other medical conditions affecting by itself balance and gait (e.g. lower limb\r<br> amputation, hemiparesis due to a stroke)\r<br>\r<br> - major orthopaedic surgery (e.g. hip or knee replacement).\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis;Parkinson Disease;Peripheral Neuropathy;Rare Diseases;Healthy;Healthy Aging", "intervention": "Other: Questionnaires, clinical scales and instrumental tests", "primary_outcome": "Balance (Mini-BESTest);Balance (Timed Up and Go test);Gait speed;Gait analysis - kinematic - stride length;Gait analysis - kinematic - duration;Gait analysis - kinematic - width of the base of support;Gait analysis - kinematic - dorsal ankle angle;Gait analysis - dynamic - reaction force;Gait analysis - dynamic - ankle power;Gait analysis - dynamic - energy;Posturography - static - centre of pressure position;Posturography - static - centre of mass position;Posturography - dynamic - centre of pressure position;Posturography - dynamic - centre of mass position", "secondary_outcome": null, "secondary_id": "24C302", "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": 4335, "title": "Functional Balance Intervention in Multiple Sclerosis", "summary": "<b>Conditions</b>: Multiple Sclerosis\n<br /><b>Interventions</b>: Behavioral: Functional Balance Intervention; Behavioral: Stretching\n<br /><b>Sponsors</b>: University of Illinois at Chicago\n<br /><b>Not yet recruiting</b>", "published_date": "2024-04-02T04:00:00Z", "discovery_date": "2024-04-13T04:26:07.623899Z", "link": "https://clinicaltrials.gov/study/NCT06341023?cond=Multiple+Sclerosis", "source": "Clinical Trials.gov", "relevant": null, "identifiers": { "nct": "NCT06341023", "euct": null, "eudract": null }, "categories": [], "export_date": "2024-04-15T00:00:00Z", "internal_number": "13879667", "last_refreshed_on": "2024-04-08", "scientific_title": "Functional Balance Intervention (FBI) for Physical and Cognitive Symptoms of Multiple Sclerosis", "primary_sponsor": "University of Illinois at Chicago", "retrospective_flag": "Yes", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Not recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "90 Years", "inclusion_gender": "All", "date_enrollement": "2024-04-14", "target_size": "120", "study_type": "Interventional", "study_design": "Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor).", "phase": "N/A", "countries": "United States", "contact_firstname": "; ;", "contact_lastname": "Tanvi Bhatt, PhD;Rudri Purohit, MS;Tanvi Bhatt, PhD", "contact_address": null, "contact_email": ";[email protected];[email protected]", "contact_tel": ";312-413-9772;312-355-4443", "contact_affiliation": "University of Illinois at Chicago;", "inclusion_criteria": "<br> Inclusion criteria:\r<br>\r<br> Telephone screening (for Study 1 and 2):\r<br>\r<br> - Age group: Adults between 55-80 years of age\r<br>\r<br> - Self-reported diagnosis of Multiple Sclerosis\r<br>\r<br> - Be on stable disease modifying therapy (DMT) for =6 months.\r<br>\r<br> - Has not received physical therapy or occupational therapy services for =6 months.\r<br>\r<br> - Able to stand up from a chair independently with or without use of handrails.\r<br>\r<br> - Score between 25-75% on the 12-item Multiple Sclerosis walking scale, which indicates\r<br> that they have mobility disability or walking dysfunction.\r<br>\r<br> - Absence of any other acute or chronic neurological (Stroke, Parkinson's disease),\r<br> cardiopulmonary, musculoskeletal (injuries like fractures or dislocations or\r<br> pathologies like Rheumatoid arthritis) or systemic diagnosis, all conditions that\r<br> except Multiple Sclerosis that can directly impact individual's ability to stand and\r<br> walk.\r<br>\r<br> - Can understand and communicate in English because the protocol will only be delivered\r<br> in English.\r<br>\r<br> - Be willing to complete all aspects of the study protocol (outcome assessments, 4-month\r<br> training, accelerometer wear, etc.).\r<br>\r<br> - Individuals who give a positive response (Yes) to the question of whether the\r<br> participants feel that their memory or thinking skills worsened lately?\" will be\r<br> marked as potential individuals with mild cognitive impairment.\r<br>\r<br> - Must be willing to come to the lab for 2 times a week for four months for training\r<br> sessions (for Study 1 participants only).\r<br>\r<br> - Must have access to the internet and must be willing to attend weekly zoom calls and\r<br> undergo monthly tests on zoom (for Study 2 participants only).\r<br>\r<br> - Must be living with a family member (for Study 2 participants only).\r<br>\r<br> - Must have a helper buddy to be present during the home exercise sessions and monthly\r<br> progression evaluation Zoom calls with the researcher (for Study 2 participants only).\r<br>\r<br> In-person Screening (for Study 1 and 2):\r<br>\r<br> - Must have mobility Disability, a score of 4.0-6.5 on the Expanded Disability Status\r<br> Scale (EDSS).\r<br>\r<br> - Must have mild cognitive impairment, a score of 18-25 on the Montreal Cognitive\r<br> Assessment (MoCA) and score >1 but less than 2.5 standard deviations on 2 or more\r<br> measures within at least 1 domain (e.g., memory, language, attention/processing speed,\r<br> executive function, visuospatial abilities) on the established criteria named \"Jak /\r<br> Bondi\" criteria.\r<br>\r<br> - Must be physically inactive, a score <14 on the questionnaire named \"Godin leisure\r<br> time\" questionnaire.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> Telephone Screening (for Study 1 and 2):\r<br>\r<br> - MS Relapse or exacerbation =3 months\r<br>\r<br> - Recent major surgery (< 6 months) or hospitalization (< 3 months) that might interfere\r<br> with testing/training.\r<br>\r<br> - Complaints of shortness of breath or uncontrolled pain (>3/10 on visual analogue scale\r<br> (VAS)) at rest to avoid complications/injuries during testing/training.\r<br>\r<br> - Uncontrolled/untreated hypertension or diabetes to avoid cardiovascular complications\r<br> during testing/training.\r<br>\r<br> - Self-reported history of bone fracture in the last six months to avoid\r<br> complications/injuries during testing/training.\r<br>\r<br> - Self-reported disability in performing activities of daily living (with or without\r<br> assistive device).\r<br>\r<br> - Self-reported diagnosis of epilepsy or uncontrolled seizures in the past year.\r<br>\r<br> - Intake of sedative drugs (diazepam, lorazepam, midazolam, propofol, dexmedetomidine,\r<br> thiopental) that might interfere with testing/training.\r<br>\r<br> - Intake of any Alzheimer's Disease (AD) or dementia modifying medications (donepezil,\r<br> rivastigmine, galantamine, aducanumab) as well as other anticipated FDA approved drugs\r<br> that may be approved during the next 5 years. Individuals who are enrolled in any AD\r<br> disease modifying drugs trials that might interfere with testing/training or affect\r<br> the ability to understand instructions will also be excluded.\r<br>\r<br> - Intake of anti-depressants or anxiety drugs.\r<br>\r<br> - Moderate or high risk for possible injury or death when undertaking strenuous or\r<br> maximal exercise as indicated by reporting a 'YES' on any of the seven items on the\r<br> Physical Activity Readiness Questionnaire. These participants will be excluded from\r<br> participation, and further advised to seek medical guidance from their physician.\r<br>\r<br> - People with severe cognitive impairment will be excluded, indicated by a score of 18\r<br> or higher on the Telephone Interview for Cognitive status (TICS-M). These participants\r<br> will be advised to seek medical guidance from the physician.\r<br>\r<br> - Currently undergoing any cognitive rehabilitation for higher brain functions or\r<br> physical rehabilitation.\r<br>\r<br> - Pacemaker users\r<br>\r<br> In-person Screening (for Study 1 and 2):\r<br>\r<br> - Cardiovascular abnormalities: Heart Rate > 85% of age-predicted maximal heart rate,\r<br> systolic blood pressure (SBP) > 165 millimetre of mercury (mmHg), diastolic blood\r<br> pressure > 110 mmHg during rest OR systolic blood pressure < 90 mmHg and/or mean\r<br> arterial blood pressure < 65 mmHg OR oxygen saturation < 95% during rest.\r<br>\r<br> - Osteopenia (a T - Score of =-2.5 on heel ultrasound). Participants with a score = -2.5\r<br> will be advised to seek medical guidance from their physician.\r<br>\r<br> - Loss of protective peripheral sensations (inability to perceive 5.07/10 g on the\r<br> Semmes Monofilament testing).\r<br>\r<br> - Global aphasia (A score of <71% on the Mississippi Aphasia Scoring test)\r<br>\r<br> - Peripheral nerve injuries (traumatic nerve lacerations, pathological nerve damage).\r<br>\r<br> - High fall-risk, <40/56 on Berg Balance Scale (for Study 2 participants only)\r<br>\r<br> - Inability to walk 1 block with or without an assistive device (for Study 2\r<br> participants only)\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis", "intervention": "Behavioral: Functional Balance Intervention;Behavioral: Stretching", "primary_outcome": "Change in physical function;Change in cognitive function;Change in dual task balance performance;Change in dual task gait performance;Change in measured community mobility;Change in self-reported community mobility;Change in self-reported quality of Life", "secondary_outcome": "Change in walking performance;Change in walking speed;Change in balance confidence;Change in functional independence", "secondary_id": "2023-1430", "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": 4334, "title": "Reproductive Options in Inherited Skin Diseases", "summary": "<b>Conditions</b>: Ichthyosis; Palmoplantar Keratoses; Epidermolysis Bullosa; Ectodermal Dysplasia; Basal Cell Nevus Syndrome; Birt-Hogg-Dube Syndrome; Tuberous Sclerosis; Xeroderma Pigmentosum; Cutis Laxa; Albinism\n<br /><b>Sponsors</b>: Maastricht University Medical Center\n<br /><b>Enrolling by invitation</b>", "published_date": "2024-03-26T04:00:00Z", "discovery_date": "2024-04-09T13:25:51.343946Z", "link": "https://clinicaltrials.gov/study/NCT06330324?cond=Multiple+Sclerosis", "source": "Clinical Trials.gov", "relevant": null, "identifiers": { "nct": "NCT06330324", "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": 4333, "title": "Physiological Effects of N-Acetyl Cysteine in Patients With Multiple Sclerosis", "summary": null, "published_date": "2017-01-19T00:00:00Z", "discovery_date": "2024-04-08T17:14:12.293294Z", "link": "https://clinicaltrials.gov/ct2/show/NCT03032601", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT03032601" }, "categories": [], "export_date": "2024-04-15T00:00:00Z", "internal_number": "13873664", "last_refreshed_on": "2024-04-08", "scientific_title": "Physiological Effects of N-Acetyl Cysteine in Patients With Multiple Sclerosis", "primary_sponsor": "Thomas Jefferson University", "retrospective_flag": "No", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "N/A", "inclusion_gender": "All", "date_enrollement": "2017-01-05", "target_size": "55", "study_type": "Interventional", "study_design": "Allocation: Randomized. Intervention model: Factorial Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).", "phase": "N/A", "countries": "United States", "contact_firstname": "", "contact_lastname": "Daniel A Monti, MD, MBA", "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": "Thomas Jefferson University", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - Clinical diagnosis of relapsing remitting MS or progressive MS who do not plan to\r<br> start a medication during the study, or on stable disease modifying medication\r<br> (interferon, glatiramer, dimethyl fumarate, teriflunomide).\r<br>\r<br> - Age 18 years old to no upper limit\r<br>\r<br> - Physically independent, ambulatory\r<br>\r<br> - Women of childbearing potential will confirm a negative pregnancy test and must\r<br> practice effective contraception during the period of pilot study. In addition, male\r<br> subjects who have a partner of childbearing age should practice effective\r<br> contraception.\r<br>\r<br> - Participants must be able to complete study procedures in the greater Philadelphia\r<br> area.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Patients are excluded who have received treatment with intravenous steroids within the\r<br> past 90 days for reasons other than MS\r<br>\r<br> - Previous brain surgery that would interfere with determination of cerebral metabolism\r<br> or structure on the FDG PET-MRI.\r<br>\r<br> - Score on Mini-Mental Status examination of 20 or lower.\r<br>\r<br> - Wheelchair-bound or bed-ridden, non-ambulatory.\r<br>\r<br> - Intracranial abnormalities that may complicate interpretation of the brain scans\r<br> (e.g., stroke, tumor, vascular abnormality affecting the target area).\r<br>\r<br> - History of head trauma with loss of consciousness > 48 hours.\r<br>\r<br> - History of asthma requiring daily medications for adequate management.\r<br>\r<br> - Any medical disorder or physical condition that could reasonably be expected to\r<br> interfere with the assessment of MS symptoms, or with any of the study assessments\r<br> including the PET-MRI imaging.\r<br>\r<br> - Patients with evidence of a significant psychiatric disorder by history/examination\r<br> that would prevent completion of the study will not be allowed to participate.\r<br>\r<br> - Patients with current alcohol or drug abuse\r<br>\r<br> - Pregnant or lactating women.\r<br>\r<br> - Enrollment in active clinical trial/ experimental therapy within the prior 30 days.\r<br>\r<br> - Pending surgery during the course of the study.\r<br>\r<br> - Patients taking medications that might interact with NAC involved in this study will\r<br> be evaluated on a case by case basis by the PI or study physician. These medications\r<br> include: Medications for high blood pressure; Medications that slow blood clotting;\r<br> Medications for diabetes; Nitroglycerin.\r<br>\r<br> - Patients with history of pulmonary hypertension.\r<br>\r<br> - Any neurological, psychiatric, or medical condition that might affect the distribution\r<br> of the radiopharmaceutical in the body or brain (as determined by Investigator)\r<br>\r<br> - Currently using medications that might alter the distribution of radiopharmaceuticals\r<br> in - -the body or brain (as determined by Investigator)\r<br>\r<br> - Patient exceeds the weight limit of the table\r<br>\r<br> - Claustrophobia that would prevent completion of imaging studies\r<br>\r<br> - Glucose level that would interfere with the FDG PET scan\r<br>\r<br> - Any additional contraindications for MRI; Has metallic objects (e.g., pacemakers) in\r<br> the body\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis", "intervention": "Dietary Supplement: N-acetyl Cysteine", "primary_outcome": "Changes in the metabolic activity in the brain, and improved parameters with regard to the inflammation associated with the active lesions based on both MRI and PET findings.", "secondary_outcome": "Mini-Mental Status examination (MMSE);Multiple Sclerosis Quality of Life Inventory (MSQLI);Health Status Questionnaire (SF-36) standard form;Modified Fatigue Impact Scale (MFIS) standard form;MOS Pain Effects Scale (PES);Bladder Control Scale (BLCS);Bowel Control Scale (BWCS);Impact of Visual Impairment Scale (IVIS);Perceived Deficits Questionnaire (PDQ) standard form;Mental Health Inventory (MHI) standard form;MOS Modified Social Support Survey (MSSS) standard form;Sexual Satisfaction Scale (SSS);Kurtzke Expanded Disability Status Scale (EDSS)", "secondary_id": "16D.672", "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": 4332, "title": "Evobrutinib compared to Teriflunomide in participants with Relapsing Multiple Sclerosis", "summary": null, "published_date": "2020-05-25T00:00:00Z", "discovery_date": "2024-04-08T17:13:58.063791Z", "link": "https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2019-004980-36", "source": "WHO XML import", "relevant": null, "identifiers": { "euctr": "EUCTR2019-004980-36-LT" }, "categories": [ { "category_id": 28, "category_description": "sg", "category_name": "Evobrutinib", "category_slug": "evobrutinib", "category_terms": [ "Evobrutinib" ], "article_count": 8 }, { "category_id": 14, "category_description": "Aubagio is a medicine that contains the active substance teriflunomide. It is used to treat patients from the age of 10 years with multiple sclerosis (MS), a disease in which inflammation destroys the protective sheath around the nerves. \r\n\r\nAubagio is used in the type of MS known as relapsing-remitting MS, when the patient has flare-ups of symptoms (relapses) followed by periods of recovery (remissions).", "category_name": "Aubagio", "category_slug": "aubagio", "category_terms": [ "teriflunomide", "aubagio" ], "article_count": 106 } ], "export_date": "2024-04-15T00:00:00Z", "internal_number": "13844119", "last_refreshed_on": "2024-04-02", "scientific_title": "A Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared with Teriflunomide, in Participants with Relapsing Multiple Sclerosis to Evaluate Efficacy and Safety. - Phase III Study of Evobrutinib in RMS (EVOLUTION RMS 2)", "primary_sponsor": "Merck Healthcare KGaA", "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": "2020-10-22", "target_size": "930", "study_type": "Interventional clinical trial of medicinal product", "study_design": "Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: yes Other trial design description: Active comparator (Aubagio), double-dummy If controlled, specify comparator, Other Medicinial Product: yes Placebo: yes Other: no Number of treatment arms in the trial: 2", "phase": "Human pharmacology (Phase I): no\nTherapeutic exploratory (Phase II): no\nTherapeutic confirmatory - (Phase III): yes\nTherapeutic use (Phase IV): no", "countries": "Russian Federation;Puerto Rico;Singapore;United States;Malaysia;Thailand;Portugal;Saudi Arabia;Greece;Latvia;Sweden;Brazil;Poland;Slovakia;Slovenia;Lithuania;Kuwait;Bulgaria;France;Tunisia;Romania;Philippines;Ukraine;Belarus;Switzerland;India;Spain;Canada;Turkey;Norway;Moldova, Republic of;Mexico;South Africa;Italy;Germany", "contact_firstname": "Communication Center", "contact_lastname": null, "contact_address": "Frankfurter Str. 250", "contact_email": "[email protected]", "contact_tel": "+49 6151 72 5200", "contact_affiliation": "Merck Healthcare KGaA", "inclusion_criteria": "Inclusion criteria: <br>For DBTP:<br>- 18 years to 55 years female and male participants <br>- Participants are diagnosed with RMS (relapsing-remitting multiple sclerosis [RRMS] or secondary progressive multiple sclerosis [SPMS] with relapses) in accordance with 2017 Revised McDonald criteria (Thompson 2018) <br>- Participants with one or more documented relapses within the 2 years before Screening with either: a. one relapse which occurred within the last year prior to randomization, OR b. the presence of at least 1 gadolinium-enhancing (Gd+) T1 lesion within 6 months prior to randomization<br>- Participants have Expanded Disability Status Scale (EDSS) score of 0 to 5.5 at Screening and Baseline (Day 1). Participants with an EDSS score <= 2 at Screening and Baseline (Day 1) are only eligible for participation if their disease duration (time since onset of symptoms) is no more than 10 years <br>- Participants are neurologically stable for >= 30 days prior to both screening and baseline<br>- Female participants must be neither pregnant nor breast-feeding or must lack child-bearing potential (as defined by either: post-menopausal or surgically sterile), or use an effective method of contraception for the duration of the study and at least 2 years after study intervention due to the long elimination period for teriflunomide of 2 years, unless the participant undergoes an accelerated elimination procedure <br>- Male participants must refrain from donating sperm and/or abstain from intercourse with women of child-bearing potential or use an effective method of contraception for the duration of the study and at least 2 years after study intervention due to the long elimination period for teriflunomide of 2 years, unless the participant undergoes an accelerated elimination procedure<br>- Participants have given written informed consent prior to any study-related procedure <br>- Other protocol defined inclusion criteria could apply. <br><br>For DBE period:<br>- Participants need to be able and willing to provide written informed consent for the DBE period before the first procedure in DBE.<br>- Participant does not fulfill any permanent discontinuation criteria based on Week 156/EODBTP assessments.<br><br>For OLE period:<br>- participants have completed the DBE Period, or are still under study treatment when enrollment into OLE is opened - but not into the long<br>term follow-up study -, and who, in the opinion of the Investigator, may benefit from treatment with evobrutinib.<br>- participants are able and willing to provide written informed consent for the OLE period (e.g., before the first OLE procedure on OLE Day 1) and to comply with the study protocol.<br>- participants have documentation of completed AEP (confirmed blood concentration level of < 0.02 mcg/mL of teriflunomide as defined in protocol) before Day 1/Baseline visit (applicable to all participants previously treated with teriflunomide, or with an unknown exposure status during the DBTP and DBE period).<br>- Women of childbearing potential are willing to continue to use the contraceptive methods as described in protocol.<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 930<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>For DBTP:<br>- Participants diagnosed with Progressive MS, in accordance with the 2017 Revised McDonald criteria as follows: a). Participants with Primary Progressive MS. b) Participants with secondary progressive MS without evidence of relapse.<br>- Disease duration more than (>) 10 years in participants with an EDSS =< 2.0 at screening.<br>- Immunologic disorder other than MS, or any other condition requiring oral, intravenous (IV) , intramuscular, or intra-articular corticosteroid therapy, with the exception of well-controlled Type 2 diabetes mellitus or well controlled thyroid disease.<br>-Other protocol defined exclusion criteria could apply.<br><br>For OLE period:<br>- Participants who did not complete study intervention in DBE period.<br>- Treatment with injectable (e.g., IV, intramuscular, intra-articular) or oral glucocorticoids, or ACTH (e.g., Acthar gel) within 30 days before<br>OLE Day 1, with the exception of rescue treatment for MS relapse specified by the study protocol.<br>- History of suicidal ideation or an episode of clinically severe depression (as determined by the Investigator) within 12 weeks prior to OLE Day 1.<br>- History of abnormal laboratory results that, in the opinion of the Investigator, are indicative of a significant cardiac, endocrine, hematologic, immunologic, metabolic urologic, pulmonary, gastrointestinal, dermatologic, psychiatric, renal, neurologic (other than MS), and/or other major diseases.<br>- Any of the following abnormal blood tests during the DBE Period requiring discontinuation of study intervention, and/or at End of DBE visit, with a week before OLE Day 1: ALT/serum glutamate pyruvate transaminase, AST/serum glutamic oxaloacetic transaminase, Total Bilirubin, amylase, or lipase, eGFR.<br>- Female participants who have a positive pregnancy test result, are pregnant, or are currently breast feeding.<br>- Inability to comply with study requirements.<br>", "condition": "Relapsing Multiple Sclerosis <br>MedDRA version: 20.0\nLevel: PT\nClassification code 10048393\nTerm: Multiple sclerosis relapse\nSystem Organ Class: 10029205 - Nervous system disorders\n <br>MedDRA version: 21.1\nLevel: PT\nClassification code 10063399\nTerm: Relapsing-remitting multiple sclerosis\nSystem Organ Class: 10029205 - Nervous system disorders\n;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]", "intervention": "<br>Product Name: Evobrutinib<br>Product Code: M2951<br>Pharmaceutical Form: Tablet<br>INN or Proposed INN: EVOBRUTINIB<br>CAS Number: 1415823-73-2<br>Current Sponsor code: M2951<br>Other descriptive name: MSC2364447C<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 45-<br>Pharmaceutical form of the placebo: Tablet<br>Route of administration of the placebo: Oral use<br><br>Trade Name: Aubagio<br>Product Name: Aubagio<br>Pharmaceutical Form: Film-coated tablet<br>INN or Proposed INN: TERIFLUNOMIDE<br>CAS Number: 108605-62-5<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 14-<br>Pharmaceutical form of the placebo: Film-coated tablet<br>Route of administration of the placebo: Oral use<br><br>", "primary_outcome": "Main Objective: For the Double-blind Treatment Period (DBTP): To demonstrate superior efficacy with evobrutinib compared to Teriflunomide in terms of Annualized Relapse Rate (ARR)<br>For the the Double-Blind Extension (DBE) Period: To further evaluate the efficacy with evobrutinib compared to teriflunomide in terms of Annualized Relapse Rate (ARR)<br>For the Open Label Extension (OLE) Period: To evaluate the long-term safety and tolerability of evobrutinib 45 mg twice daily (BID) in participants with Relapsing Multiple Sclerosis (RMS) over time;Secondary Objective: DBTP-to demonstrate the efficacy of evobrutinib relative to that of Teriflunomide: <br>a.on disability progression (DP); b.on disability improvement; c.on patient reported symptoms and functional status; d.on magnetic resonance imaging (MRI) lesion parameters; e.by evaluating response on Neurofilament light chain (NfL) concentrations in serum; and f.to characterize the safety and tolerability of evobrutinib.<br>DBE Period-to further evaluate the efficacy of evobrutinib relative to that of teriflunomide: <br>a.on DP; b. n disability improvement; c.on patient reported symptoms and functional status; d. on MRI lesion parameters; and e.to further characterize the safety and tolerability of evobrutinib.<br>OLE Period-to evaluate the long-term efficacy of evobrutinib 45mg BID:<br>a.in participants with RMS; b.in participants with RMS on patient reported symptoms and functional status; c.to further evaluate the longterm safety and tolerability of evobrutinib 45mg BID in participants with RMS over time.;Primary end point(s): For DBTP: ARR based on qualified relapses at up to 156 weeks in participants with RMS<br>For DBE Period: ARR based on qualified relapses in participants with RMS<br>For OLE period: Occurrence of AEs and SAEs;Timepoint(s) of evaluation of this end point: For DBTP: up to 156 weeks<br>For DBE Period: up to 96 weeks<br>For OLE period: Entire OLE duration", "secondary_outcome": "Secondary end point(s): For DBTP:<br>a. Time to first occurrence of 12-week confirmed disability progression (CDP) as measured by the Expanded Disability Status Scale (EDSS) up to<br>156 weeks<br>b. Time to first occurrence of 24-week CDP as measured by EDSS up to 156 weeks<br>c. Time to first occurrence of 24-week Confirmed Disability Improvement (CDI) as measured by the EDSS up to 156 weeks<br>d. Change from Baseline (CFB) in Patient Reported Outcomes Measurement Information System [PROMIS] PF score over 96 weeks<br>e. CFB in PROMIS Fatigue score over 96 weeks<br>f. Total number of T1 Gd+ lesions on all available MRI scans<br>g. Number of new or enlarging T2 lesions on the last available MRI scan relative to the baseline MRI scan<br>h. NfL concentration at 12 weeks<br>i. Safety as assessed by the nature, severity, and occurrence of adverse events (AEs) and adverse events of special interest (AESIs); vital signs; electrocardiograms (ECGs); absolute concentrations and change from Baseline in immunoglobulin (Ig) levels; and clinical laboratory safety<br>parameters up to the end of the Safety Follow-up period<br><br>For DBE Period:<br>a. Time to first occurrence of 12-week CDP as measured by EDSS<br>b. Time to first occurrence of 24-week CDP as measured by EDSS<br>c. Time to first occurrence of 24-week CDP as measured by the EDSS<br>d. CFB in PROMIS PF score over time<br>e. CFB in PROMIS Fatigue score over time<br>f. Total number of T1 Gd+ lesions based on all available MRI scans<br>g. Number of new or enlarging T2 lesions on the last available MRI scan relative to the baseline MRI scan<br>h. Safety as assessed by the nature, severity, and occurrence of AEs and AESIs; vital signs; ECGs; absolute concentrations and CFB in Ig levels; and clinical laboratory safety parameters up to the end of the Safety Follow-up period.<br><br>For OLE period:<br>a. ARR based on protocol defined qualified relapses<br>b. Time to first occurrence of 24-week CDP as measured by EDSS<br>c. Time to first occurrence of 24-week CDI as measured by EDSS<br>d. SDMT over time<br>e. PROMISnq PF (MS) 15a score change over time<br>f. PROMIS Fatigue (MS) 8a score change over time<br>g. Safety Laboratory Parameters including Blood Chemistry, Hematology, Coagulation, Vitals, ECGs;Timepoint(s) of evaluation of this end point: For DBTP: <br>a. 12 week up to 156 weeks<br>b.c 24-week up to 156 weeks<br>d.e. over 96 weeks<br>f: Total number of T1 Gd+ lesions based on all available MRI scans<br>g. Number of new or enlarging T2 lesions on the last available MRI scan<br>relative to the baseline MRI scan<br>h. at 12 weeks<br>i. end of the Safety Follow-up period<br><br>For DBE period:<br>a. at 12 weeks<br>b., c. at 24 weeks<br>d., e., f., g., h. for up to 96 weeks<br><br>For OLE period:<br>a., d., e., f., g. for up to 96 weeks<br>b., c. 24-weeks<br>", "secondary_id": "MS200527_0082;Evolution RMS 2;2019-004980-36-PT", "source_support": "Merck Healthcare KGaA", "ethics_review_status": "Approved", "ethics_review_approval_date": "2020-06-25", "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": 4331, "title": "To Evaluate the Efficacy and Safety of Fenebrutinib Compared with Teriflunomide in Adult Patients with Relapsing Multiple Sclerosis", "summary": null, "published_date": "2020-11-30T00:00:00Z", "discovery_date": "2024-04-08T17:13:55.765749Z", "link": "https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001168-28", "source": "WHO XML import", "relevant": null, "identifiers": { "euctr": "EUCTR2020-001168-28-DK" }, "categories": [ { "category_id": 14, "category_description": "Aubagio is a medicine that contains the active substance teriflunomide. It is used to treat patients from the age of 10 years with multiple sclerosis (MS), a disease in which inflammation destroys the protective sheath around the nerves. \r\n\r\nAubagio is used in the type of MS known as relapsing-remitting MS, when the patient has flare-ups of symptoms (relapses) followed by periods of recovery (remissions).", "category_name": "Aubagio", "category_slug": "aubagio", "category_terms": [ "teriflunomide", "aubagio" ], "article_count": 106 } ], "export_date": "2024-04-15T00:00:00Z", "internal_number": "13844253", "last_refreshed_on": "2024-04-02", "scientific_title": "A PHASE III MULTICENTER, RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF FENEBRUTINIB COMPARED WITH TERIFLUNOMIDE IN ADULT PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS", "primary_sponsor": "F. Hoffmann-La Roche Ltd", "retrospective_flag": "Yes", "date_registration": null, "source_register": "EU Clinical Trials Register", "recruitment_status": "Authorised", "other_records": "Yes", "inclusion_agemin": null, "inclusion_agemax": null, "inclusion_gender": "<br>Female: yes<br>Male: yes<br>", "date_enrollement": "2021-01-03", "target_size": "736", "study_type": "Interventional clinical trial of medicinal product", "study_design": "Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: yes Other trial design description: Double-Dummy If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: yes Other specify the comparator: Aubagio Number of treatment arms in the trial: 2", "phase": "Human pharmacology (Phase I): no\nTherapeutic exploratory (Phase II): no\nTherapeutic confirmatory - (Phase III): yes\nTherapeutic use (Phase IV): no", "countries": "Russian Federation;United States;United Kingdom;India;Greece;Canada;Austria;Netherlands;Finland;Denmark;Guatemala;Brazil;Korea, Republic of;Poland;Mexico;Italy;Bulgaria;France;Türkiye", "contact_firstname": "Trial Information Support Line-TISL", "contact_lastname": null, "contact_address": "Grenzacherstrasse 124", "contact_email": "[email protected]", "contact_tel": null, "contact_affiliation": "F. Hoffmann-La Roche Ltd", "inclusion_criteria": "Inclusion criteria: <br>• Age 18-55 years<br>• Expanded Disability Status Scale score (EDSS) of 0.0-5.5 at screening<br>• A diagnosis of RMS in accordance with the revised 2017 McDonald Criteria<br>• Neurologically stable for at least 30 days prior to randomization and baseline assessments<br>• Ability to complete the 9-HPT for each hand in < 240 seconds<br>• Ability to perform the timed 25-Foot Walk Test in <150 seconds<br>• For women of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating eggs, women must remain abstinent or use contraceptive methods with a failure rate of < 1% per year during the treatment period, for 8 weeks after the final dose of study medication, and until the teriflunomide elimination protocol is completed<br>• For men: agreement to remain abstinent or use a condom, and agreement to refrain from donating sperm, with a female partner of childbearing potential or pregnant female partner, men must remain abstinent or use a condom during the treatment phase, for 8 weeks after the final dose of study drug, and until completion of the teriflunomide elimination protocol. Men must also refrain from donating sperm during this same period<br>OLE Inclusion Criteria:<br>• Completed the Double-Blind Treatment (DBT) phase of the study (remaining on study treatment; no other Disease-Modifying Therapy (DMT) administered) and who, in the opinion of the investigator, may benefit from treatment with fenebrutinib<br>• Patients randomized to the teriflunomide treatment arm during the DBT phase must undergo the ATEP prior to the first administration of open-label fenebrutinib<br>• For female participants of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating eggs, women must remain abstinent or use contraceptive methods with a failure rate of < 1% per year during the treatment period, the OLE treatment phase and for 28 days after the final dose of open-label fenebrutinib. Women must also refrain from donating eggs during this same period<br>• For male participants: agreement to remain abstinent or use a condom, and agreement to refrain from donating sperm, with a female partner of childbearing potential or pregnant female partner, men must remain abstinent or use a condom during the treatment phase, OLE treatment phase and for 28 days after the final dose of open-label fenebrutinib to avoid exposing the embryo. Men must also refrain from donating sperm during this same period.<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 736<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>•\tA diagnosis of PPMS or non-active SPMS<br>•\tDisease duration of > 10 years from the onset of symptoms and an EDSS score at screening < 2.0<br>•\tAny known or suspected active infection at screening or baseline, or any major episode of infection requiring hospitalization or treatment with IV anti-microbials within 8 weeks prior to and during screening or treatment with oral anti-microbials within 2 weeks prior to and during screening. Onychomycosis is not exclusionary unless it is being treated with systemic therapy<br>•\tHistory of cancer including hematologic malignancy and solid tumors within 10 years of screening. <br>•\tKnown presence of other neurological disorders that could interfere with the diagnosis of MS or assessments of efficacy or safety during the study, clinically significant cardiovascular, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic or gastrointestinal disease<br>•\tAny concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study <br>•\tHistory of alcohol or other drug abuse within 12 months prior to screening<br>•\tAny previous treatment with immunomodulatory or immunosuppressive medication without an appropriate washout period<br>•\tReceipt of a live or live-attenuated vaccine within 6 weeks prior to randomization<br>•\tFemale participants who are pregnant or breastfeeding or intending to become pregnant during the study or 8 weeks (with ATEP) after final dose of study drug<br>•\tMale participants intending to father a child during the study or 8 weeks (with ATEP) after final dose of study drug<br>•\tPresence of cirrhosis (Child-Pugh Class A, B, or C) or Gilbert’s Syndrome<br>", "condition": "Relapsing multiple sclerosis (RMS) <br>MedDRA version: 20.0\nLevel: PT\nClassification code 10048393\nTerm: Multiple sclerosis relapse\nSystem Organ Class: 10029205 - Nervous system disorders\n <br>MedDRA version: 27.0\nLevel: PT\nClassification code 10080700\nTerm: Relapsing multiple sclerosis\nSystem Organ Class: 10029205 - Nervous system disorders\n;Therapeutic area: Diseases [C] - Immune System Diseases [C20]", "intervention": "<br>Product Name: fenebrutinib<br>Product Code: RO7010939<br>Pharmaceutical Form: Film-coated tablet<br>INN or Proposed INN: FENEBRUTINIB<br>Current Sponsor code: RO7010939<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 100-<br>Pharmaceutical form of the placebo: Film-coated tablet<br>Route of administration of the placebo: Oral use<br><br>Trade Name: Aubagio<br>Product Name: Teriflunomide<br>Pharmaceutical Form: Capsule, hard<br>INN or Proposed INN: TERIFLUNOMIDE<br>CAS Number: 108605-62-5<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 14-<br>Pharmaceutical form of the placebo: Capsule, hard<br>Route of administration of the placebo: Oral use<br><br>", "primary_outcome": "Main Objective: • To evaluate the efficacy of fenebrutinib compared with teriflunomide on the basis of annualized relapse rate (ARR);Secondary Objective: • To evaluate the efficacy of fenebrutinib treatment compared with teriflunomide on the basis of time to onset of composite 24-week confirmed composite disability progression (cCDP24), Time to onset of composite 12-week confirmed disability progression (cCDP12), time to onset of 12-week confirmed disability progression (CDP12), time to onset of 24-week CDP (CDP24), total number of T1Gd+ lesions as detected by MRI, total number of new and/or enlarging T2-weighted lesions as detected by MRI, rate of percent change in total brain volume from Week 24 as assessed by MRI, change in patient-reported physical impacts of MS, time to onset of 12-week confirmed 4-point worsening in Symbol Digit Modalities Test (SDMT) score, change from baseline to Week 48 in the concentration of serum neurofilament light chain (NfL)<br>• To evaluate the safety of fenebrutinib compared with teriflunomide<br>• To characterize the fenebrutinib pharmacokinetics profile;Primary end point(s): 1. Annualized relapse rate<br>;Timepoint(s) of evaluation of this end point: 1. 96 Weeks<br>", "secondary_outcome": "Secondary end point(s): 1.\tTime to onset of cCDP12<br>2.\tTime to onset of CDP12<br>3.\tTime to onset of cCDP24<br>4.\tTime to onset of CDP24<br>5.\tTotal number of gadolinium-enhancing lesions on T1-weighted MRI lesions as detected by MRI<br>6.\tTotal number of new and/or enlarging T2-weighted lesions as detected by MRI<br>7.\tRate of percent change in total brain volume from Week 24 as assessed by MRI<br>8.\tRate of change from baseline in patient-reported physical impacts of MS, as measured by the Multiple Sclerosis Impact Scale (29-Item), Version 2 (MSIS-29 v2) physical scale)<br>9.\tTime to onset of 12-week confirmed 4-point worsening in SDMT score<br>10.\tChange from baseline to Week 48 in the concentration of serum neurofilament light chain (NfL)<br>11.\tThe nature, frequency, timing, and severity of adverse events; serious adverse events; and adverse events leading to study treatment discontinuation or dose interruptions<br>12.\tChange from baseline in targeted vital signs<br>13.\tChange from baseline in targeted ECG parameters<br>14.\tChange from baseline in clinical laboratory results<br>15.\tProportion of patients with suicidal ideation or behavior<br>16.\tPlasma concentration of fenebrutinib at specified timepoints<br>;Timepoint(s) of evaluation of this end point: 1-2. Time from baseline to the first occurrence of a progression event and must be confirmed at least 12 weeks after the initial disability progression<br>3-4. Time from baseline to first occurrence of a progression event and must be confirmed at least 24 weeks after initial disability progression<br>5-6. Timepoints up to primary analysis <br>7. Week 24 to Week 96<br>8. At baseline, Week 12, 24, 36, 48, 60, 72, 84, 96<br>9. Time from baseline to first occurrence of 4-point worsening in SDMT event and must be confirmed at least 12 weeks after the initial event<br>10. Baseline to Week 48<br>11. Baseline to primary analysis<br>12-15. Baseline to primary analysis<br>16. Week 4, 12, 24, 48, 72, 96 and at treatment discontinuation, unscheduled visit", "secondary_id": "GN42272", "source_support": "Genentech Inc. c/o F. Hoffman-La Roche Ltd.", "ethics_review_status": "Approved", "ethics_review_approval_date": "2021-01-03", "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": 4330, "title": "A phase 2 trial assessing Ifenprodil as a ReMyelinating repurpOsed Drug in Multiple Sclerosis – MODIF-MS", "summary": null, "published_date": "2023-10-11T00:00:00Z", "discovery_date": "2024-04-08T17:13:43.109342Z", "link": "https://euclinicaltrials.eu/app/#/view/2023-507874-42-00?lang=en", "source": "WHO XML import", "relevant": null, "identifiers": { "ctis": "CTIS2023-507874-42-00" }, "categories": [], "export_date": "2024-04-15T00:00:00Z", "internal_number": "13844807", "last_refreshed_on": "2024-04-02", "scientific_title": "A phase 2 trial assessing Ifenprodil as a ReMyelinating repurpOsed Drug in Multiple Sclerosis – MODIF-MS", "primary_sponsor": "Assistance Publique Hopitaux De Paris", "retrospective_flag": "Yes", "date_registration": null, "source_register": "Clinical Trials Information System", "recruitment_status": "Not Recruiting", "other_records": "No", "inclusion_agemin": "18", "inclusion_agemax": "64", "inclusion_gender": "Female: yes Male: yes", "date_enrollement": "2024-03-18", "target_size": "80", "study_type": "Interventional clinical trial of medicinal product", "study_design": "Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Number of treatment arms in the trial: 2", "phase": "Human pharmacology (Phase I): yes Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use - (Phase IV): no", "countries": "France", "contact_firstname": "Sophie Courtial-Destembert", "contact_lastname": null, "contact_address": null, "contact_email": "[email protected]", "contact_tel": "+3340275591", "contact_affiliation": "Assistance Publique Hopitaux De Paris", "inclusion_criteria": "Inclusion criteria: For patients 1.\tSigned informed consent form at pre-inclusion visit,9.\tEDSS score = 6 at time of pre-inclusion visit,For Healthy Volunteers 1.\tSigned informed consent form,2.\tAge between 18 years and 55 years, inclusive,3.\tAll female subjects of childbearing potential must practice effective contraception include oral contraception, intrauterine devices hormonal device, intrauterine hormone-releasing system, sterilization method and other forms of contraception with failure rate <1%),4.\tAble to comply with the study protocol, in the investigator’s judgment,5.\tSocial security registration (AME excluded),10.\tEfficient contraception include oral contraception, intrauterine devices hormonal device, intrauterine hormone-releasing system, sterilization method and other forms of contraception with failure rate <1%),2.\tAge between 18 years and 55 years, inclusive, at time of pre-inclusion visit,3.\tPatient with a RR form of MS according McDonald criteria 2017 at pre-inclusion visit,4.\tAble to comply with the study protocol and to understand the purpose and risks of the study, in the investigator’s judgment,5.\tSocial security registration (AME excluded) at time of pre-inclusion visit,6.\tAt least one eye with a P100 latency > 118ms on visual evoked potential at baseline (defining the qualifying eye) at time of pre-inclusion visit,7.\tRetinal nerve fibre layer thickness on spectral-domain optical coherence tomography [OCT] > 70 µm in the VEP qualifying eye (to increase the likelihood that the number of surviving axons is sufficient to provide the substrate for remyelination to occur) at time of pre-inclusion visit,8.\tPatient under disease modifying therapy (first or second line approved immune active therapy) or patient without any DMT at time of pre-inclusion visit", "exclusion_criteria": "Exclusion criteria: For patients 1.\tPatient with an acute NORB in the last 6 months prior to pre-inclusion visit,18.\tDeprive of freedom or under security measure,19.\tParticipation in another interventional trial evaluating a health product or any randomized trial or being in the exclusion period at the end of a previous study,2.\tPatient with a clinical relapse other than NORB in the last 6 months prior to pre-inclusion visit,20.\tRefusal to be informed in case of clinically significant incidental discovery after MRI,3.\tPatients having received methylprednisolone infusion in the last 4 weeks prior to pre-inclusion visit,4.\tContraindications to investigational medicinal products (ifenprodil/placebo) and to auxiliary medicinal products (gadolinium, [18F]-florbetaben),5.\tInability to complete an MRI (contraindications for MRI include but are not restricted to weight = 140 kg, pacemaker, cochlear implants, presence of foreign substances in the eye, intracranial vascular clips, surgery within 6 weeks of entry into the study, coronary stent implanted within 8 weeks prior to the time of the intended MRI, contraindication to gadoteric acid etc.).,6.\tPET imaging performed in the past 12 months as part of clinical research,7.\tHistory or incidental discovery of significant cardiac conduction block,8.\tOrthostatic hypotension Syndrome define as a drop of > 20 mmHg in systolic, and/or > 10 mmHg in diastolic between lying down and immediate standing,10.\tAny uncontrolled general (cancer, infectious, hematologic, hepatic, immunologic, endocrinologic, neurologic, dermatologic, psychiatric, allergic, renal, or cardiovascular) disease.,9.\tKnown long QT syndrome or long QT syndrome (the limit is defined at 450 ms on corrected QT) highlighted during the pre-inclusion visit,For healthy volunteers 1.\tInability to complete an MRI (contraindications for MRI include but are not restricted to weight = 140 kg, pacemaker, cochlear implants, presence of foreign substances in the eye, intracranial vascular clips, surgery within 6 weeks of entry into the study, coronary stent implanted within 8 weeks prior to the time of the intended MRI, etc).,2.\tImpossibility to complete a PET scan: pregnancy, nuclear medicine irradiation for clinical research in the year preceding baseline visit.,3.\tContraindication to auxiliary medicinal products ([18F]-florbetaben),4.\tKnown presence of any neurological disorders,5.\tPregnancy and/or lactation,6.\tLack of peripheral venous access,7.\tTerminal renal insufficiency (Creatinin clearance < 60 ml/min),8.\tLegal protection (curatorship or tutorship),9.\tDeprive of freedom or under security measure,11.\tCreatinine clearance < 60 ml/min at pre-inclusion visit,10.\tParticipation in another interventional trial evaluating a health product or any randomized trial or being in the exclusion period at the end of a previous study,11.\tRefusal to be informed in case of clinically significant incidental discovery after MRI,12.\tASAT, ALAT of alkaline phosphatase > 3-fold the upper limit normal at pre-inclusion visit,13.\tKnow Galactosemia, glucose malabsorption or lactase deficiency,14.\tKnown of lack of peripheral venous access or lack of peripheral venous access highlighted during the pre-inclusion visit,15.\tThrombocytopenia with platelets < 100 000/mm3,16.\tPregnancy and/or lactating women,17.\tLegal protection (curatorship or tutorship)", "condition": "Multiple sclerosis <br>MedDRA version: 20.1Level: PTClassification code: 10028245Term: Multiple sclerosisSystem Organ Class: 100000004852 <br>MedDRA version: 20.1Level: LLTClassification code: 10039720Term: Sclerosis multipleSystem Organ Class: 10029205 <br>MedDRA version: 20.0Level: SOCClassification code: 10029205Term: Nervous system disordersSystem Organ Class: 8;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05];MedDRA version: 20.1Level: PTClassification code: 10028245Term: Multiple sclerosisSystem Organ Class: 100000004852;MedDRA version: 20.1Level: LLTClassification code: 10039720Term: Sclerosis multipleSystem Organ Class: 10029205;MedDRA version: 20.0Level: SOCClassification code: 10029205Term: Nervous system disordersSystem Organ Class: 8", "intervention": "Product Name: IFENPRODIL TARTRATE,Product Code: SUB02636MIG,Pharmaceutical Form: FILM-COATED TABLET,Other descriptive name: ,Strength: 20mg,Product Name: DOTAREM 0,5 mmol/mL, solution injectable,Product Code: PRD354062,Pharmaceutical Form: SOLUTION FOR INJECTION,Other descriptive name: ,Strength: Gadoteric Acid 27.932g / 100mL,Product Name: Placebo of Ifenprodil 20 mg,Product Code: N/A,Pharmaceutical Form: N/A,Other descriptive name: N/A,Strength: N/A,Pharmaceutical form of the placebo: N/A,Product Name: FLORBETABEN (18F),Product Code: SUB119774,Pharmaceutical Form: SOLUTION FOR INJECTION,Other descriptive name: ,Strength: 300megaBq", "primary_outcome": "Main Objective:To assess the efficacy of ifenprodil on the remyelination of the optic nerve measured as the improvement of P100 latency, assessed using full field visual evoked potentials;Secondary Objective:-To determine whether the treatment by ifenprodil could increase remyelination of brain white matter (WM) lesions of patients with MS, as measured by myelin PET,-To determine whether the treatment by ifenprodil could increase cortical repair as measured by magnetization transfer imaging,-To determine whether the treatment by ifenprodil could influence axonal damage in the visual pathway assessed by the amplitude of P100,-To determine whether the treatment by ifenprodil could influence neurodegeneration measured by optical coherence tomography (OCT) parameters,-To determine whether the treatment by ifenprodil could influence axonal damage assessed by the blood concentration of neurofilament light chain (NfL),-To determine whether the treatment by ifenprodil could influence white matter lesions load or brain atrophy rate,-To determine whether the treatment by ifenprodil could influence disability assessed by EDSS, MSFC, ophtalmological parameters, and BICAMS cognitive scores,-To determine whether the efficacy of ifenprodil is influenced by endogenous remyelination profiles assessed in the run-in period, and to describe the profile of optimal responders,-To assess whether the disease modifying therapies received during the study influence the remyelination level and/or the ifenprodil effect on remyelinationctives,-To detect and report side effects related to ifenprodil: changes in vital signs, blood pressure, physical and neurological examination, electrocardiogram, laboratory results, white matter lesion load on MRI.,-To assess the correlation of the biomarker GFAP with imaging and clinical metrics of patients, and investigate whether blood GFAP level is influenced by ifenprodil,-To assess whether blood biomarkers reflecting myelin (MBP, MOG) could reflect the level of demyelination and remyelination in patients and investigate whether blood MOG and MBP levels are influenced by ifenprodil.,-The EDSS, MSFC and BICAMS cognitive scores at M6 and M12 in each group,-The change in visual acuity measures from Pre-inclusion visit to M6 and from M6 to M12,-The correlation between the change in the proportion of remyelinating voxels extracted in white matter lesions from [18F]florbetaben PET acquisitions between M6 and M12 and the pre-treatment individual remyelination profiles as determined during the Run-in period.,-The comparison of the proportion of remyelinating voxels extracted in white matter lesions from [18F]florbetaben PET acquisitions between M6 and M12 across group receiving DMT (considered either as a whole, or subdivided in first line and second line treatments) or not receiving DMT.,-The change between M6 and M12 in blood pressure,-The detection of an orthostatic hypotension at Pre-inclusion visit, M6, M9, M12,-The changes between M6 and M12 on electrocardiogram (including QT duration),-The changes in laboratory parameters: hemogram, electrolyte, liver markers at pre-inclusion visit, M6, M9, M12.,-The change in T2 white matter lesion number and volume on MRI between M0 and M6 and between M6 and M12,-The onset clinical relapses during each period of the study (and their number),-The number of relapses from M0 to M6 and from M6 to M12,-The change in blood concentration of GFAP from M0 to M6 and from M6 to M12 in each group.,-The change in blood concentration of MOG and MBP from M0 to M6 and from M6 to M12 (quantification centralized in Basle University, Dr D. Leppert, Dr J. Kuhle);Primary end point(s):-The change in P100 latency between M6 (end of run-in) and M12 (end of treatment period) in each group according to visual evoked potential.", "secondary_outcome": "Secondary end point(s):-\tThe change in remyelination potential measured by PET-MR (= proportion of voxels within white matter lesions classified as remyelinating between M6 (end of run-in, calculation of pre-treatment remyelination potential, randomization) and M12 (end of follow-up, calculation of post-treatment remyelination potential) in each group.;Secondary end point(s):-\tThe change in the proportion of remyelinating voxels extracted in cortical regions from MTR acquisitions (as cortical myelin in not assessed by PET) between M6 and M12 (as recently described in Lazzarotto et al 2022) in each group.;Secondary end point(s):-\tThe change in amplitude of P100 on VEPs from M6 to M12 in each group;Secondary end point(s):-\tThe change in retinal nerve fibre layer (RNFL) and ganglion cell complex (GCC) thickness on OCT from M6 to M12 in each group.;Secondary end point(s):-\tThe change in blood concentration of NfL fragments, NfL from Pre-inclusion visit to M6 and from M6 to M9 and M6 to M12 (quantification centralized in Nîmes University Hospital, Pr E. Thouvenot) in each group;Secondary end point(s):-\tThe number and volume of white matter (WM) lesions from M0 to M6 and from M6 to M12 in each group;Secondary end point(s):-\tThe brain atrophy rate from M0 to M6 and from M6 to M12 in each group", "secondary_id": null, "source_support": "Ministère de la Santé, Programme Hospitalier de Recherche Clinique National 2019", "ethics_review_status": "Authorized", "ethics_review_approval_date": "2024-03-18", "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": 4329, "title": "Improving Social Cognition and Social Behaviour in Various Brain Disorders", "summary": "<b>Conditions</b>: Stroke; Multiple Sclerosis; Brain Tumor\n<br /><b>Interventions</b>: Behavioral: Treatment social cognition and emotion regulation (T-ScEmo)\n<br /><b>Sponsors</b>: University Medical Center Groningen\n<br /><b>Recruiting</b>", "published_date": "2023-12-12T00:00:00Z", "discovery_date": "2024-04-08T17:13:42.606642Z", "link": "https://clinicaltrials.gov/ct2/show/NCT06330298", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT06330298", "euct": null, "eudract": null }, "categories": [], "export_date": "2024-04-15T00:00:00Z", "internal_number": "13828874", "last_refreshed_on": "2024-04-01", "scientific_title": "Improving Social Cognition and Social Behaviour in Various Brain Disorders.", "primary_sponsor": "University Medical Center Groningen", "retrospective_flag": "No", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "75 Years", "inclusion_gender": "All", "date_enrollement": "2021-05-31", "target_size": "84", "study_type": "Interventional", "study_design": "Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Investigator).", "phase": "N/A", "countries": "Netherlands", "contact_firstname": ";", "contact_lastname": "J.M. Spikman, Prof. Dr.;A Heegers, MSc.", "contact_address": null, "contact_email": ";[email protected]", "contact_tel": ";+31503614666", "contact_affiliation": "Department of Neurology - Unit Neuropsychology of the University Medical Center Groningen (UMCG);", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - Patients should have social cognitive disorders that show by means of problems in\r<br> emotion recognition, perspective taking, ToM, showing empathy, or behaviour.\r<br>\r<br> - Patients should have a neurological disorder; stroke (including patients with\r<br> subarachnoid haemorrhage), Multiple sclerosis (MS), both relapsing remitting, primary\r<br> and secondary progressive variants, Brain tumours (meningioma's, low grade gliomas)\r<br> and other categories of neurological disorders including brain damage: (i.e.\r<br> infections (meningitis, encephalitis), post anoxic encephalopathy, adult survivors of\r<br> childhood brain tumours).\r<br>\r<br> - Patients should be aged between 18 and 75\r<br>\r<br> - Patients should be in the chronic stage (> 6 months post-acute injuries) or their\r<br> medical condition should be relatively stable (for patients with a slow progressive\r<br> conditions), to be judged by the treating medical or psychological specialist, in\r<br> order to be able to profit from treatment for a reasonable time period.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Serious neurodegenerative or psychiatric conditions (including addiction) interfering\r<br> with treatment\r<br>\r<br> - Incapacity to act, to be judged by the neuropsychologist and/or neurologist\r<br>\r<br> - Serious cognitive problems (aphasia, neglect, amnesia, dementia) and/or serious\r<br> behavioural problems (aggression, apathy) interfering with treatment, to be judged by\r<br> neuropsychologist.\r<br>\r<br> - Serious (other) medical conditions or physical inability hindering patients to come to\r<br> the hospital/rehabilitation centre\r<br>\r<br> - Not being available of a close other (life partner, family member, close friend) who\r<br> can fill out the proxy questionnaires\r<br>\r<br> - Not willing to give permission to send important/unexpected findings to the general\r<br> practitioner.\r<br>\r<br> - Unexpected progression of disease during the study can be a reason to exclude the\r<br> patient\r<br>\r<br> - Not sufficient command of the Dutch Language.\r<br>", "exclusion_criteria": null, "condition": "Stroke;Multiple Sclerosis;Brain Tumor", "intervention": "Behavioral: Treatment social cognition and emotion regulation (T-ScEmo)", "primary_outcome": "Change in social behaviour examined by proxy", "secondary_outcome": "Social cognition: Emotion recognition as assessed using the Eckman-60 faces test;Social cognition: Theory of Mind as assessed using the Happé cartoons test;Social cognition: Theory of Mind as assessed using the Faux Pas test;Social cognition: assessed using the Hailing Sentence Completion Test;Demographic information;Self-rated social behaviour as assessed using the Dysexecutive questionnaire Social Scales.;Self-rated social behaviour as assessed using the Interpersonal Reactivity Index;Self-rated social behaviour as assessed using The Dutch version of the BAFQ social scales;Proxy-rated social behaviour as assessed using the Interpersonal Reactivity Index;Proxy-rated social behaviour as assessed using the Socioemotional Dysfunction Scale;Proxy-rated social behaviour as assessed using the Dutch version of the BAFQ social scales;Alexithymia;Life satisfaction;(Social) participation as assessed using the Utrecht Scale for Evaluation of Rehabilitation;(Social) participation as assessed using the Impact on Participation and Autonomy scale;Mood and anxiety;Caregiving burden;Goal attainment", "secondary_id": "202000479", "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": 4328, "title": "Intestinal Immunity in Neurologic Disease", "summary": "<b>Conditions</b>: Multiple Sclerosis; Parkinson Disease; REM Sleep Behavior Disorder\n<br /><b>Interventions</b>: Procedure: Colon Tissue Biopsy\n<br /><b>Sponsors</b>: Yale University\n<br /><b>Recruiting</b>", "published_date": "2024-01-29T00:00:00Z", "discovery_date": "2024-04-08T17:13:42.189192Z", "link": "https://clinicaltrials.gov/ct2/show/NCT06329453", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT06329453", "euct": null, "eudract": null }, "categories": [], "export_date": "2024-04-15T00:00:00Z", "internal_number": "13828809", "last_refreshed_on": "2024-04-01", "scientific_title": "Intestinal Immunity in Neurologic Disease", "primary_sponsor": "Yale University", "retrospective_flag": "No", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "99 Years", "inclusion_gender": "All", "date_enrollement": "2022-08-02", "target_size": "100", "study_type": "Observational", "study_design": null, "phase": null, "countries": "United States", "contact_firstname": "; ;", "contact_lastname": "Erin Longbrake;Cynthia Marques;Cynthia Marques", "contact_address": null, "contact_email": ";[email protected];[email protected]", "contact_tel": ";2032876100;203-287-6100", "contact_affiliation": "Yale University;", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - Age 18 and up\r<br>\r<br> ONE of the following:\r<br>\r<br> - Recommended to under a screening colonoscopy (+/- upper endoscopy) as part of standard\r<br> of care. This includes healthy individuals as well as those with neurologic and/or\r<br> autoimmune diseases. OR\r<br>\r<br> - Willing to undergo research colonoscopy (+/- upper endoscopy) for research\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Currently pregnant. Women of childbearing potential would perform a point of care\r<br> urine pregnancy test prior to colonoscopy/endoscopy.\r<br>\r<br> - Known or suspected, chronic inflammatory gastrointestinal disease (e.g. inflammatory\r<br> bowel disease)\r<br>\r<br> - Known, acute or chronic infections\r<br>\r<br> - Systemic antibiotic (PO or IV) use within 3 months of colonoscopy\r<br>\r<br> - Systemic corticosteroid use (equivalent of prednisone 10 mg per day or higher for >5\r<br> days) within 2 weeks of colonoscopy\r<br>\r<br> - Malignancy, diagnosed or treated within the last 5 years\r<br>\r<br> - Probiotic use within 2 weeks of procedure\r<br>\r<br> - History of major GI surgery (e.g. colon resection, gastric bypass)\r<br>\r<br> - Bleeding disorder, or on anticoagulant medication\r<br>\r<br> - Other medical condition that, in the judgement of the investigator, would lead to\r<br> higher-than-expected risks of biopsy\r<br>\r<br> - Allergy to MAC anesthesia or other drugs used pursuant to standard of care for\r<br> biospecimen collection\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis;Parkinson Disease;REM Sleep Behavior Disorder", "intervention": "Procedure: Colon Tissue Biopsy", "primary_outcome": "Characterization of immune cells from the gastrointestinal mucosa", "secondary_outcome": "Evaluate spatial transcriptomics of intestinal tissue;Characterize the microbiome at different anatomic sites within the gastrointestinal tract", "secondary_id": "2000033081", "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": 4327, "title": "Assessing the Cognitive Benefits of Ozanimod and Their Brain-Biomarkers in MS", "summary": "<b>Conditions</b>: Multiple Sclerosis\n<br /><b>Interventions</b>: Drug: Ozanimod\n<br /><b>Sponsors</b>: The University of Texas at Dallas; Texas Institute for Neurological Disorders\n<br /><b>Not yet recruiting</b>", "published_date": "2024-02-26T00:00:00Z", "discovery_date": "2024-04-08T17:13:41.741030Z", "link": "https://clinicaltrials.gov/ct2/show/NCT06334094", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT06334094", "euct": null, "eudract": null }, "categories": [ { "category_id": 25, "category_description": "Ozanimod", "category_name": "Ozanimod", "category_slug": "ozanimod", "category_terms": [ "ozanimod", "zeposia" ], "article_count": 29 } ], "export_date": "2024-04-15T00:00:00Z", "internal_number": "13879357", "last_refreshed_on": "2024-04-08", "scientific_title": "Assessing the Cognitive Benefits of Ozanimod and Their Brain-Biomarkers in MS", "primary_sponsor": "The University of Texas at Dallas", "retrospective_flag": "Yes", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Not recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "65 Years", "inclusion_gender": "All", "date_enrollement": "2024-06-01", "target_size": "30", "study_type": "Interventional", "study_design": "Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).", "phase": "Phase 4", "countries": "United States", "contact_firstname": "; ;", "contact_lastname": "Bart Rypma, PhD;Jessica Ma, BS;Jessica Ma, BS", "contact_address": null, "contact_email": ";[email protected];[email protected]", "contact_tel": ";(972) 883-3414;972-883-3414", "contact_affiliation": "The University of Texas at Dallas;", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> 1. English-speaking Relapsing-Remitting MS (RRMS; intermittent symptom exacerbations\r<br> followed by periods of remission) patients.\r<br>\r<br> 2. Male and female, between the ages of 18-55 years old will be recruited from the Texas\r<br> Institute for Neurological Disorders (TIND) and MS Clinic of The University of Texas\r<br> Southwestern. Study referrals will come from board-certified neurologists.\r<br>\r<br> 3. Patients will have a McDonald-criteria diagnosis of RRMS, be >30 days past\r<br> exacerbation and corticosteroid treatment.\r<br>\r<br> 4. Included patients will also be free of substance abuse and significant medical, other\r<br> neurological, or psychiatric conditions unrelated to their MS disease course.\r<br>\r<br> 5. Patient selection will be limited to patients that are treatment naïve (i.e., have not\r<br> been previously treated for their MS) or require a change in treatment course.\r<br>\r<br> 6. A clinical determination is needed as to whether ozanimod is the best treatment for a\r<br> patient or whether a patient requires treatment change to ozanimod.\r<br>\r<br> 7. All included participants will be right-handed and at least high-school educated.\r<br>\r<br> 8. Only patients who score above 25 on the Telephone Interview for Cognitive Status\r<br> (TICS) will be included.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> 1. During calibrated functional magnetic resonance imaging (fMRI) scanning, participants\r<br> will inhale a carbon dioxide/room air solution to allow for calibration of BOLD\r<br> signal. Thus, to ensure participant safety, the investigators exclude: smokers and\r<br> those with MR-contraindicators, any participants with a history of respiratory or\r<br> pulmonary problems (e.g., asthma, Chronic Obstructive Pulmonary Disease (COPD),\r<br> sarcoidosis, tuberculosis), any participant with a history of cerebral vascular\r<br> disease (e.g., cardiac disease, transient ischemic attack, migraines, stroke,\r<br> arteriovenous malformation), any participant with a history of respiratory or\r<br> pulmonary problems (e.g., asthma, Chronic Obstructive Pulmonary Disease (COPD),\r<br> sarcoidosis, tuberculosis), and any participant with a history of cerebral vascular\r<br> disease (e.g., cardiac disease, transient ischemic attack, migraines, stroke,\r<br> arteriovenous malformation).\r<br>\r<br> 2. Participants that present with EKG abnormalities consistent with FDA labeling\r<br> contained within the ozanimod guidelines will be excluded as these abnormalities may\r<br> be indication of dangerous negative side effects upon ozanimod consumption. EKG\r<br> abnormalities include presence of atrioventricular (AV) block, sick sinus syndrome, or\r<br> sino-atrial block. Any experiences of myocardial infarction, unstable angina, stroke,\r<br> transient ischemic attack, decompensated heart failure requiring hospitalization, or\r<br> Class III or IV heart failure within the last 6 months will exclude the patient.\r<br> Contraindicators of ozanimod that may be found in the blood sample include presence of\r<br> varicella titers and enzyme/protein levels that indicate liver dysfunction. Thus,\r<br> these participants will be excluded.\r<br>\r<br> 3. Patients who exhibit diseases other than MS that may be responsible for the patient's\r<br> clinical, or MRI presentation will be excluded.\r<br>\r<br> 4. Patients who exhibit a history of hypersensitivity to ozanimod or any drugs of similar\r<br> chemical classes (i.e., sphingosine phosphates) will be excluded.\r<br>\r<br> 5. Female participants who are pregnant or nursing will be excluded from the study. After\r<br> the participant consents to being in the study, there will be a screening appointment\r<br> to determine their eligibility, at which a pregnancy test will be provided. Other\r<br> examinations, such as neurological assessments and EKGs, will occur at this\r<br> appointment.\r<br>\r<br> 6. Patients who are not native-English speakers will be excluded, as their English\r<br> ability may limit their understanding of the instructions and performance on the\r<br> neuropsychological tests.\r<br>\r<br> 7. Patients who score below 25 on the Telephone Interview for Cognitive Status (TICS)\r<br> will be excluded.\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis", "intervention": "Drug: Ozanimod", "primary_outcome": "Change in Processing Speed/Symbol-Digit Modality Test (SDMT) Performance", "secondary_outcome": "Change in Volumetric Blood-Oxygen-Level-Dependent (BOLD) signal as Measured by Dual Echo Functional Magnetic Resonance Imaging (fMRI);Change in Cerebral Blood Flow (CBF) as Measured by Dual Echo Functional Magnetic Resonance Imaging (fMRI);Change in Cerebral Metabolic Rate of Oxygen (CMRO2) as Measured by Dual Echo Functional Magnetic Resonance Imaging (fMRI);Change in Whole Brain Volume as Measured By Structural Magnetic Resonance Imaging;Differences in Diffusion parameters of ozanimod-responders to non-responders as Measured By a Diffusion Kurtosis Resonance Imaging (DKI)", "secondary_id": "IM047-1054;IRB-23-486", "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 } ] }