Trial List
List all clinical trials by discovery date. Accepts regular expressions in search.
GET /trials/?format=api&page=483
{ "count": 4842, "next": "http://api.gregory-ms.com/trials/?format=api&page=484", "previous": "http://api.gregory-ms.com/trials/?format=api&page=482", "results": [ { "trial_id": 24, "title": "Emotions in Multiple Sclerosis", "summary": "Condition: Multiple SclerosisIntervention: Diagnostic Test: Carrying out a tests and questionnaires batterySponsor : Lille Catholic UniversityNot yet recruiting ", "published_date": "2021-03-16T00:00:00Z", "discovery_date": "2021-03-18T11:23:53Z", "link": "https://clinicaltrials.gov/show/NCT04804787", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT04804787" }, "categories": [], "export_date": "2024-04-27T00:00:00Z", "internal_number": "13154597", "last_refreshed_on": "2023-07-03", "scientific_title": "Emotions Recognition in Multiple Sclerosis", "primary_sponsor": "Lille Catholic University", "retrospective_flag": "Yes", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "55 Years", "inclusion_gender": "All", "date_enrollement": "2021-06-23", "target_size": "100", "study_type": "Interventional", "study_design": "Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).", "phase": "N/A", "countries": "France", "contact_firstname": "; ;", "contact_lastname": "Bruno Lenne;Amélie Lansiaux, MD, PhD;Bruno Lenne", "contact_address": null, "contact_email": ";[email protected];", "contact_tel": ";03.20.22.52.69;", "contact_affiliation": "Hôpital Saint-Vincent de Paul - Lille;", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - Male or female between 18 and 55 years old.\r<br>\r<br> - Understand and able to express themselves in French.\r<br>\r<br> - EXPERIMENTAL GROUP :\r<br>\r<br> - Relapsing-remitting form (RRMS)\r<br>\r<br> - With an EDSS < 4 (Expanded Disability Status Scale)\r<br>\r<br> - No significant motor, cerebellar or somatosensory disorders of the upper limbs or\r<br> visual disorders (EDSS specific parameter <2)\r<br>\r<br> - No flare-up in the last 6 weeks\r<br>\r<br> - No corticosteroids taken in the last 4 weeks\r<br>\r<br> - CONTROL GROUP :\r<br>\r<br> - Lack of global cognitive deterioration (according to Brief International Cognitive\r<br> Assessment for Multiple Sclerosis (BICAMS) standards).\r<br>\r<br> - Gender, age and education level matching to the multiple sclerosis patients\r<br>\r<br> - Understanding and signing the informed consent and information letter regarding\r<br> participation in the study.\r<br>\r<br> - Benefiting from health insurance coverage.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Persons with previous neurological pathologies, head trauma with loss of\r<br> consciousness, psychiatric pathologies, serious general affections, perceptive or\r<br> dysarthric disorders preventing verbal communication or reading,\r<br>\r<br> - People with sensory disorders (visual and auditory) that interfere with the\r<br> performance of neuropsychological tests;\r<br>\r<br> - Treatment with psychotropic drugs (except benzodiazepines and hypnotics).\r<br>\r<br> - Refusal to participate after clear and fair information about the study.\r<br>\r<br> - Major persons under guardianship, under judicial protection, persons deprived of\r<br> liberty.\r<br>\r<br> - Pregnant or breastfeeding women\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis", "intervention": "Diagnostic Test: Carrying out a tests and questionnaires battery", "primary_outcome": "Emotion's valence;Emotion's intensity;Emotion recognition;Certainty's degree of answers", "secondary_outcome": "California Verbal Learning Test (CVLT);Brief Visuo-spatial Memory Test (BVMT);Symbol Digit Modalities Test (SDMT);Stroop test;Trail Making test;Verbal fluency test;Beck Depression Inventory (BDI);State Trait Anxiety Inventory Y-A (STAI Y-A);State Trait Anxiety Inventory Y-B (STAI Y-B);Toronto Alexithymia Scale-20 (TAS-20);Dot Probe Task;Change in the electrodermal response during emotion recognition test", "secondary_id": "RC-P00107", "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": 22, "title": "Efficacy of COVID-19 Vaccination in Patients With Multiple Sclerosis Treated With Immune Modulating Medication", "summary": "Condition: Multiple SclerosisIntervention: Other: Analysis of cell-mediated and antibody-mediated immunity to SARS-CoV-2 virusSponsor : Providence Health & ServicesNot yet recruiting ", "published_date": "2021-11-03T00:00:00Z", "discovery_date": "2021-03-15T14:45:21Z", "link": "https://clinicaltrials.gov/show/NCT04796584", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT04796584" }, "categories": [], "export_date": "2024-04-27T00:00:00Z", "internal_number": "12959260", "last_refreshed_on": "2023-04-10", "scientific_title": "Efficacy of COVID 19 SARS-CoV-2 mRNA Vaccination in Patients With Multiple Sclerosis Treated With Immune Modulating Medication (SARSmRNA_MS)", "primary_sponsor": "Providence Health & Services", "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": "2022-07-11", "target_size": "20", "study_type": "Observational", "study_design": null, "phase": null, "countries": "United States", "contact_firstname": "", "contact_lastname": "Stanley Cohan, MD PhD", "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": "Providence Health & Services", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> 1. Able to understand the purpose, benefits, and risks of the study; willing and able to\r<br> adhere to the study requirements; able to provide informed consent in English\r<br>\r<br> 2. Male or female, between the ages of 18 and 65 years inclusive at time of consent\r<br>\r<br> 3. Meet one of the following:\r<br>\r<br> 1. Plan to receive one of the FDA approved mRNA-based COVID SARS-CoV-2 vaccinations\r<br> within 30 days of the screening visit\r<br>\r<br> 2. Have received one of the FDA approved mRNA-based COVID SARS-CoV-2 vaccinations,\r<br> their first vaccine injection having occurred 45±7 days prior to the screening\r<br> visit\r<br>\r<br> 3. Have received one of the FDA approved mRNA-based COVID SARS-CoV-2 vaccinations,\r<br> their first vaccine injection having occurred 90±7 days prior to the screening\r<br> visit\r<br>\r<br> 4. Meet the criteria of one of the four groups at the time of consent:\r<br>\r<br> Group 1: Diagnosed with multiple sclerosis and currently being treated with a stable dose\r<br> of ocrelizumab, for 6 months or longer Group 2: Diagnosed with multiple sclerosis and\r<br> currently being treated with a stable dose of fingolimod, for 6 months or longer Group 3:\r<br> Diagnosed with multiple sclerosis and currently being treated with a stable dose of\r<br> natalizumab, for 6 months or longer Group 4: Diagnosed with multiple sclerosis and\r<br> currently being treated with a stable dose of dimethyl fumarate or diroximel fumarate, for\r<br> 6 months or longer\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> 1. Subjects who have a BMI of >35.0 will be excluded\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis", "intervention": "Other: Analysis of cell-mediated and antibody-mediated immunity to SARS-CoV-2 virus", "primary_outcome": "Titer of antibody against SARS-CoV-2 spike protein;Quantity of IFN-g secreted in response to stimulation with SARS-CoV-2 spike protein;Quantity of TNF-a secreted in response to stimulation with SARS-CoV-2 spike protein", "secondary_outcome": "Titer of antibody against SARS-CoV-2 spike protein;Quantity of IFN-g secreted in response to stimulation with SARS-CoV-2 spike protein;Quantity of TNF-a secreted in response to stimulation with SARS-CoV-2 spike protein;Titer of antibody against SARS-CoV-2 spike protein;Quantity of IFN-g secreted in response to stimulation with SARS-CoV-2 spike protein;Titer of antibody against SARS-CoV-2 spike protein;Quantity of TNF-a secreted in response to stimulation with SARS-CoV-2 spike protein;Quantity of IFN-g secreted in response to stimulation with SARS-CoV-2 spike protein", "secondary_id": "SARSmRNA_MS", "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": 23, "title": "Pathogenicity of B and CD4 T Cell Subsets in Multiple Sclerosis", "summary": "Conditions: Multiple Sclerosis; Clinically Isolated SyndromeInterventions: Biological: blood sample; Biological: cerebro-spinal fluidSponsors : University Hospital, Bordeaux; University of BordeauxNot yet recruiting ", "published_date": "2021-11-03T00:00:00Z", "discovery_date": "2021-03-15T14:45:21Z", "link": "https://clinicaltrials.gov/ct2/show/NCT04798651", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT04798651" }, "categories": [], "export_date": "2024-04-27T00:00:00Z", "internal_number": "13666192", "last_refreshed_on": "2024-01-29", "scientific_title": "Pathogenicity of B and CD4 T Cell Subsets in Multiple Sclerosis", "primary_sponsor": "University Hospital, Bordeaux", "retrospective_flag": "Yes", "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": "2021-09-30", "target_size": "150", "study_type": "Interventional", "study_design": "Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).", "phase": "N/A", "countries": "France", "contact_firstname": "; ; ;", "contact_lastname": "Aurélie RUET, Prof;Nathalie SCHMITT, PhD;Aurélie RUET, Prof;Aurélie RUET, Prof", "contact_address": null, "contact_email": ";;[email protected];[email protected]", "contact_tel": ";;05 56 79 55 21;", "contact_affiliation": "CHU Bordeaux;University of Bordeaux;", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - male or female subjects ;\r<br>\r<br> - Age = 18 years;\r<br>\r<br> - subjects with MS defined by 2010 revised McDonald criteria or presenting a clinical\r<br> isolated syndrome;\r<br>\r<br> - patients for which a blood draw and / or lumbar puncture to collect CSF is performed\r<br> for diagnostic or therapeutic purpose;\r<br>\r<br> - affiliated to an health insurance system;\r<br>\r<br> - and who agree to participate in the study.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Pregnant or breastfeeding women,\r<br>\r<br> - patient concerned by articles L 1121-5 to L 1121-8 (persons deprived of their liberty\r<br> by a judicial or administrative decision, minors, persons of legal age who are the\r<br> object of a legal protection measure or unable to express their consent)\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis;Clinically Isolated Syndrome", "intervention": "Biological: blood sample;Biological: cerebro-spinal fluid", "primary_outcome": "Functional and phenotypical characterization of the blood and CSF lymphocytes in MS and CIS patients.", "secondary_outcome": "Quantification of disease activity scores;Quantification of disease activity scores;Number of lesions;Size of lesions;Localisation of lesions;Types of lesions;duration of the disease;age at onset and progression;number of relapses;date of relapses;Treatment", "secondary_id": "CHUBX 2020/71", "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": 21, "title": "Role of Individualized Versus Traditional Exercise in Combating Fatigue", "summary": "Condition: Multiple SclerosisInterventions: Other: Adapted and individualized physical training program; Other: traditional training programSponsor : Centre Hospitalier Universitaire de Saint EtienneNot yet recruiting ", "published_date": "2021-01-15T00:00:00Z", "discovery_date": "2021-03-12T14:58:20Z", "link": "https://clinicaltrials.gov/ct2/show/NCT04796272", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT04796272" }, "categories": [], "export_date": "2024-04-27T00:00:00Z", "internal_number": "13524256", "last_refreshed_on": "2023-11-13", "scientific_title": "Role of Individualized Versus Traditional Exercise in Combating Fatigue in Fatigued Multiple Sclerosis Patients", "primary_sponsor": "Centre Hospitalier Universitaire de Saint Etienne", "retrospective_flag": "Yes", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Not recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "70 Years", "inclusion_gender": "All", "date_enrollement": "2021-04-02", "target_size": "30", "study_type": "Interventional", "study_design": "Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Health Services Research. Masking: Single (Participant).", "phase": "N/A", "countries": "France", "contact_firstname": "", "contact_lastname": "Jean Philippe CAMDESSANCHE, MD PhD", "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": "CHU SAINT-ETIENNE", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - Aged 18 to 70 years old\r<br>\r<br> - Male or female\r<br>\r<br> - With relapsing-remitting multiple sclerosis (RRMS) as defined by McDonald's 2010\r<br> criteria.\r<br>\r<br> - Between 2 and 25 years from the onset of multiple sclerosis\r<br>\r<br> - With a high level of fatigue, corresponding to a score of Fatigue Severity Scale> 4\r<br> and Fatigue questionnaire > 38.\r<br>\r<br> - Expanded Disability Status Scale Score 5\r<br>\r<br> - Testing = 4 in all leg muscles.\r<br>\r<br> - Ability to walk for 10 minutes without stopping (self-reported)\r<br>\r<br> - Affiliates or beneficiaries of a social security scheme\r<br>\r<br> - Having freely given their written consent after having been informed of the purpose,\r<br> course of action and potential risks involved\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Severe cerebellar spasticity or ataxia in either leg.\r<br>\r<br> - Abnormal range of motion of the toes and/or ankle.\r<br>\r<br> - Musculoskeletal injury that interferes with pedaling.\r<br>\r<br> - High resting heart rate (>90 beats per minute).\r<br>\r<br> - Blood pressure > 144/94 mmHg.\r<br>\r<br> - Onset of a multiple sclerosis attack within 90 days prior to the study.\r<br>\r<br> - Recent adjustment of any medication or drugs that may impact on fatigue, or taking\r<br> stimulants for fatigue (e.g. Modafinil).\r<br>\r<br> - Taking of neuro-active substances that may impair cortico-spinal excitability\r<br> (hypnotics, antiepileptics, psychotropic drugs, muscle relaxants) throughout the study\r<br> period.\r<br>\r<br> - Contraindication to the application of a magnetic field\r<br>\r<br> - History of co-morbid disease or conditions that would compromise the subject's safety\r<br> during the study.\r<br>\r<br> - Participation at the same time in another medical intervention study or having\r<br> participated in such a study within 30 days prior to this study.\r<br>\r<br> - Pregnant and Nursing Women\r<br>\r<br> - Women of childbearing age without effective contraception\r<br>\r<br> - Patient unable to understand the purpose and conditions of the study, incapable of\r<br> giving consent\r<br>\r<br> - Patient deprived of liberty or patient under guardianship\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis", "intervention": "Other: Adapted and individualized physical training program;Other: traditional training program", "primary_outcome": "Chronic fatigue score", "secondary_outcome": "cardiorespiratory fitness;Hematological parameters;Inflammatory parameters;quality of sleep;cortical activation level;cortico-spinal excitability;neuromuscular fatigue of peripheral function;Analysis overall quality of life : Fatigue questionnaire;Analysis overall quality of life :Quality of Life;Analysis overall quality of life :Depression;Analysis overall quality of life : Sleep Quality;Analysis overall quality of life : Physical Activity", "secondary_id": "2020-A00841-38;20CH032", "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": 20, "title": "Post-COntrast 3D SE T1 Versus Coronal SE T1-WI MRI in Detecting Optic Neuritis (COCON)", "summary": "Conditions: Optic Neuritis; Multiple SclerosisIntervention: Diagnostic Test: Magnetic Resonance ImagingSponsor : Fondation Ophtalmologique Adolphe de RothschildCompleted ", "published_date": "2021-08-03T00:00:00Z", "discovery_date": "2021-03-11T12:25:31Z", "link": "https://clinicaltrials.gov/show/NCT04793087", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT04793087" }, "categories": [], "export_date": "2024-04-27T00:00:00Z", "internal_number": "10749130", "last_refreshed_on": "2021-03-22", "scientific_title": "Post-COntrast 3D SE T1 Versus Coronal SE T1-WI MRI in Detecting Optic Neuritis in Patients Presenting With Acute Visual Loss and Otherwise Normal Ophthalmological Examination", "primary_sponsor": "Fondation Ophtalmologique Adolphe de Rothschild", "retrospective_flag": "No", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Not recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "N/A", "inclusion_gender": "All", "date_enrollement": "2018-01-01", "target_size": "1200", "study_type": "Observational", "study_design": null, "phase": null, "countries": "France", "contact_firstname": null, "contact_lastname": null, "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": null, "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - Age > 18 years\r<br>\r<br> - Decrease in visual acuity explored in MRI between january 2018 and january 2020\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Past history of episode of Optic neuritis\r<br>", "exclusion_criteria": null, "condition": "Optic Neuritis;Multiple Sclerosis", "intervention": "Diagnostic Test: Magnetic Resonance Imaging", "primary_outcome": "Detection of optic neuropathies using MRI", "secondary_outcome": null, "secondary_id": "CE_20200204_2_ALR", "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": 19, "title": "3D FLAIR Versus Coronal T2-WI MRI in Detecting Optic Neuritis (FLACON)", "summary": "Conditions: Optic Neuritis; Multiple Sclerosis; EncephalopathyIntervention: Diagnostic Test: Magnetic Resonance ImagingSponsor : Fondation Ophtalmologique Adolphe de RothschildCompleted ", "published_date": "2021-08-03T00:00:00Z", "discovery_date": "2021-03-11T12:25:31Z", "link": "https://clinicaltrials.gov/show/NCT04792866", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT04792866" }, "categories": [], "export_date": "2024-04-27T00:00:00Z", "internal_number": "10749115", "last_refreshed_on": "2021-03-22", "scientific_title": "3D FLAIR Versus Coronal T2-WI MRI in Detecting Optic Neuritis in Patients Presenting With Acute Visual Loss and Otherwise Normal Ophthalmological Examination", "primary_sponsor": "Fondation Ophtalmologique Adolphe de Rothschild", "retrospective_flag": "No", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Not recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "N/A", "inclusion_gender": "All", "date_enrollement": "2018-01-01", "target_size": "1200", "study_type": "Observational", "study_design": null, "phase": null, "countries": "France", "contact_firstname": null, "contact_lastname": null, "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": null, "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - Age > 18 years\r<br>\r<br> - Decrease in visual acuity explored in MRI between january 2018 and january 2020\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Past history of episode of Optic neuritis\r<br>", "exclusion_criteria": null, "condition": "Optic Neuritis;Multiple Sclerosis;Encephalopathy", "intervention": "Diagnostic Test: Magnetic Resonance Imaging", "primary_outcome": "Detection of optic neuropathies using MRI", "secondary_outcome": null, "secondary_id": "CE_20200204_1_ALR", "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": 18, "title": "Exploring the Immune Response to SARS-CoV-2 modRNA Vaccines in Patients With Secondary Progressive Multiple Sclerosis (AMA-VACC)", "summary": "Condition: Secondary Progressive Multiple SclerosisInterventions: Drug: BAF312; Drug: Baseline disease modifying therapies (DMTs)Sponsor : Novartis PharmaceuticalsNot yet recruiting ", "published_date": "2021-08-03T00:00:00Z", "discovery_date": "2021-03-11T12:25:30Z", "link": "https://clinicaltrials.gov/show/NCT04792567", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT04792567" }, "categories": [], "export_date": "2024-04-27T00:00:00Z", "internal_number": "12728904", "last_refreshed_on": "2023-01-09", "scientific_title": "An Open-label Multicenter Study to Assess Response to SARS-CoV-2 modRNA Vaccines in Participants With Secondary Progressive Multiple Sclerosis Treated With Mayzent (Siponimod)", "primary_sponsor": "Novartis Pharmaceuticals", "retrospective_flag": "Yes", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Not recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "100 Years", "inclusion_gender": "All", "date_enrollement": "2021-04-19", "target_size": "41", "study_type": "Interventional", "study_design": "Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).", "phase": "Phase 4", "countries": "Germany", "contact_firstname": null, "contact_lastname": null, "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": null, "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - Secondary Progressive Multiple Sclerosis (SPMS) diagnosis or with Relapsing Remitting\r<br> Multiple Sclerosis (RRMS) at risk to develop SPMS (at the discretion of the treating\r<br> physician)\r<br>\r<br> - on stable MS treatment (Siponimod, dimethylfumarate, glatirameracetate, interferon,\r<br> teriflunomode or no current treatment)\r<br>\r<br> - no recent treatment changes\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - prior or current COVID-19 disease\r<br>\r<br> - SARS-CoV-2 antibodies at screening Other protocol-defined inclusion/exclusion criteria\r<br> may apply\r<br>", "exclusion_criteria": null, "condition": "Secondary Progressive Multiple Sclerosis", "intervention": "Drug: BAF312;Drug: Baseline disease modifying therapies (DMTs)", "primary_outcome": "Percentage of participants achieving seroconversion after receiving a modRNA vaccine", "secondary_outcome": "SARS-CoV-2 serum functional antibody levels over time;T-cell response to modRNA vaccines over time;Number of treatment emergent adverse events, serious adverse events and COVID-19 infections", "secondary_id": "2020-005752-38;CBAF312ADE03", "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": 17, "title": "Open Label Randomized Multicenter to Assess Efficacy & Tolerability of Ofatumumab 20mg vs. First Line DMT in RMS", "summary": "Condition: Multiple SclerosisInterventions: Drug: Ofatumumab; Drug: First line DMTSponsor : Novartis PharmaceuticalsNot yet recruiting ", "published_date": "2021-08-03T00:00:00Z", "discovery_date": "2021-03-09T14:59:53Z", "link": "https://clinicaltrials.gov/ct2/show/NCT04788615", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT04788615" }, "categories": [ { "category_id": 39, "category_description": "ofatumumab, Kesimpta", "category_name": "Ofatumumab", "category_slug": "ofatumumab", "category_terms": [ "ofatumumab", "kesimpta" ], "article_count": 45 } ], "export_date": "2024-04-27T00:00:00Z", "internal_number": "13792290", "last_refreshed_on": "2024-03-11", "scientific_title": "Open-Label Rater-Blind Randomized Multi-Center Parallel-Arm Active- Comparator Study to Assess the Efficacy and Tolerability of Ofatumumab 20mg SC Monthly vs. First Line DMT - Physician's Choice in the Treatment of Newly Diagnosed RMS", "primary_sponsor": "Novartis Pharmaceuticals", "retrospective_flag": "Yes", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "55 Years", "inclusion_gender": "All", "date_enrollement": "2021-07-23", "target_size": "186", "study_type": "Interventional", "study_design": "Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).", "phase": "Phase 3", "countries": "France;Germany;Italy;Spain;United Kingdom;France;Germany;Italy;Spain;United Kingdom", "contact_firstname": ";", "contact_lastname": "Novartis Pharmaceuticals;Novartis Pharmaceuticals", "contact_address": null, "contact_email": ";[email protected]", "contact_tel": ";+41613241111", "contact_affiliation": "Novartis Pharmaceuticals;", "inclusion_criteria": "<br> Inclusion Criteria\r<br>\r<br> 1. Written informed consent obtained before any assessment\r<br>\r<br> 2. Male/female patients, 18 through 55 (inclusive) years of age.\r<br>\r<br> 3. Diagnosis of MS according to the 2017 revised McDonald criteria (Thompson et al 2018).\r<br>\r<br> 4. Relapsing MS: relapsing-course (RMS), as defined by Lublin et al 2014.\r<br>\r<br> 5. Treatment Naïve patients, = 5 years since first MS symptom.\r<br>\r<br> 6. EDSS score 0-4.0 (inclusive).\r<br>\r<br> 7. Patient must be suitable to be treated with one of first line self-administered\r<br> DMT-physician's choice (glatiramer acetate, IFNs, teriflunomide, DMF, diroximel\r<br> fumarate according to EMA SmPC) or ofatumumab depending on randomization and\r<br> physician's choice\r<br>\r<br> 8. At least 1 relapse or 1 Gd+ enhanced lesion on T1 in 1 year prior to Screening.\r<br>\r<br> 9. Able to obtain MRI assessment.\r<br>\r<br> 10. Neurologically stable within 1 month prior to first study drug administration\r<br> Exclusion Criteria\r<br>\r<br> 1. Diseases other than multiple sclerosis responsible for the clinical or MRI\r<br> presentation\r<br>\r<br> 2. Progressive MS phenotypes: Patients with primary progressive MS (Polman et al 2011) or\r<br> SPMS (Lublin et al 2014).\r<br>\r<br> 3. Use of other experimental or investigational drugs at the time of enrollment\r<br> (Screening) or within the prior 30 days, or 5 elimination half-lives, or until the\r<br> expected pharmacodynamics effect has returned to baseline, whichever is longer\r<br>\r<br> 4. Relapse between Screening and Baseline visits\r<br>\r<br> 5. Pregnancy or breastfeeding\r<br>\r<br> 6. Patients suspected of not being able or willing to cooperate or comply with study\r<br> protocol requirements in the opinion of the Investigator\r<br>\r<br> 7. Women of childbearing potential defined as all women physiologically capable of\r<br> becoming pregnant, unless they are using highly effective methods of contraception\r<br> (methods that result in less than 1% pregnancy rates) while receiving ofatumumab and\r<br> for 6 months after the last administration. The requirements for contraception for the\r<br> comparators should also be taken into consideration according to their SmPC.\r<br>\r<br> Highly effective methods of contraception include:\r<br>\r<br> - Total abstinence (when this is in line with the preferred and usual lifestyle of\r<br> the participant). Sexual abstinence is considered a highly effective method only\r<br> if defined as refraining from heterosexual intercourse during the entire period\r<br> of risk associated with the study treatments. The reliability of sexual\r<br> abstinence needs to be evaluated in relation to the duration of the clinical\r<br> trial and the preferred and usual lifestyle of the participant. Periodic\r<br> abstinence (e.g. calendar, ovulation, symptothermal, postovulation methods) and\r<br> withdrawal are not acceptable methods of contraception.\r<br>\r<br> - Female sterilization (have had surgical bilateral oophorectomy with or without\r<br> hysterectomy), total hysterectomy, or bilateral tubal ligation at least six weeks\r<br> before taking study treatment. In case of oophorectomy alone, only when the\r<br> reproductive status of the woman has been confirmed by follow up hormone level\r<br> assessment.\r<br>\r<br> - Male sterilization (at least 6 months prior to screening). For female\r<br> participants on the study, the vasectomized male partner should be the sole\r<br> partner for that participant.\r<br>\r<br> (Vasectomized partner is a highly effective birth control method provided that partner\r<br> is the sole sexual partner of the WOCBP trial participant and that the vasectomized\r<br> partner has received medical assessment of the surgical success.) - Use of combined,\r<br> estrogen and progesterone containing (oral, intravaginal, transdermal), hormonal\r<br> methods of contraception or use of progesterone-only (oral, injectable, implantable)\r<br> hormonal methods of contraception or placement of an intrauterine device (IUD) or\r<br> intrauterine system (IUS), or other forms of hormonal contraception that have\r<br> comparable efficacy (failure rate <1%), for example hormone vaginal ring or\r<br> transdermal hormone contraception. In case of use of oral contraception women should\r<br> have been stable on the same pill for a minimum of 3 months before taking study\r<br> treatment. Women are considered post-menopausal if they have had 12 months of natural\r<br> (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate\r<br> history of vasomotor symptoms). Women are considered not of childbearing potential if\r<br> they are post-menopausal or have had surgical bilateral oophorectomy (with or without\r<br> hysterectomy), total hysterectomy or bilateral tubal ligation at least six weeks ago.\r<br> In the case of oophorectomy alone, only when the reproductive status of the woman has\r<br> been confirmed by follow up hormone level assessment is she considered not of\r<br> childbearing potential. If local regulations deviate from the contraception methods\r<br> listed above to prevent pregnancy, local regulations apply and will be described in\r<br> the ICF.\r<br>\r<br> 8. Patients with an active chronic disease (or stable but treated with immune therapy) of\r<br> the immune system other than MS (e.g. rheumatoid arthritis, scleroderma, Sjögren's\r<br> syndrome, Crohn's disease, ulcerative colitis, etc.) or with immunodeficiency syndrome\r<br> (hereditary immune deficiency, drug-induced immune deficiency)\r<br>\r<br> 9. Patients with an active infection (bacterial, fungal, or viral like hepatitis, HIV or\r<br> COVID), until the infection is resolved. Where local regulation requires it,\r<br> Sars-Cov-19 must be ruled out by the PCR test.\r<br>\r<br> 10. Patients with neurological findings consistent with Progressive Multifocal\r<br> Leukoencephalopathy (PML), or confirmed PML\r<br>\r<br> 11. Positive results at Screening for serological markers for hepatitis (H) B and C\r<br> indicating acute or chronic infection:\r<br>\r<br> - Hepatitis B virus (HBV) screening should be performed before initiation of\r<br> treatment.\r<br>\r<br> At a minimum, screening should include hepatitis B surface antigen (HBsAg) and\r<br> hepatitis B core antibody (HBcAb) testing. These can be complemented with other\r<br> appropriate markers as per local guidelines. Patients with positive hepatitis B\r<br> serology (either HBsAg or HBcAb) should consult a liver disease expert before the\r<br> start of treatment and should be monitored and managed following local medical\r<br> standards to prevent hepatitis B reactivation.\r<br>\r<br> - Hepatitis C risk must be ruled out via anti-HC IgG (if positive IgG, HCV-RNA PCR\r<br> will be performed and if negative, patient can be enrolled) NOTE: If the Investigator\r<br> suspects false positive hepatitis serology results such as an antibody pattern\r<br> indicating acute hepa", "exclusion_criteria": null, "condition": "Multiple Sclerosis", "intervention": "Drug: Ofatumumab;Drug: First line DMT", "primary_outcome": "Number of participants with no evidence of disease activity (NEDA-3)", "secondary_outcome": "Number of relapses;Annual relapse rate;Percentage of relapse-free patients and proportion of relapse free patients with MRI activity free;Time to 3 month Confirmed Disability Worsening (CDW) and time to 6-month Confirmed Disability Worsening (CDW);Change in expanded disability status scale (EDSS);Percentage of disability-progression free patients;Number of Gd+ T1 lesions of brain;The number and percentage of patients with Treatment emergent adverse events (TEAE) or adverse events reports;Volume of Gd+ T1 lesions of brain;Number of new/enlarging T2 lesions of brain;Volume of new enlarging T2 lesions of brain;Mean time to first relapse;Percentage of SAEs, and SAEs with hospitalizations;Percentage of treatment compliance of participants;Percentage of patient with AEs;Percentage of withdrawn patients;Percentage of treatment discontinuation or interruptions", "secondary_id": "2020-004505-32;COMB157G3301", "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": 16, "title": "T Cell Profiling in Patients With Multiple Sclerosis", "summary": "Condition: Multiple SclerosisIntervention: Other: Blood SampleSponsor : Boston Children's HospitalNot yet recruiting ", "published_date": "2021-05-03T00:00:00Z", "discovery_date": "2021-03-09T14:59:53Z", "link": "https://clinicaltrials.gov/ct2/show/NCT04789551", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT04789551" }, "categories": [], "export_date": "2024-04-27T00:00:00Z", "internal_number": "13565779", "last_refreshed_on": "2023-12-04", "scientific_title": "T Cell Profiling in Patients With Multiple Sclerosis", "primary_sponsor": "Boston Children's Hospital", "retrospective_flag": "Yes", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Not recruiting", "other_records": "No", "inclusion_agemin": "13 Years", "inclusion_agemax": "20 Years", "inclusion_gender": "All", "date_enrollement": "2024-06-01", "target_size": "40", "study_type": "Observational", "study_design": null, "phase": null, "countries": "United States", "contact_firstname": ";", "contact_lastname": "Lifei Hou, PhD;Lifei Hou, PhD", "contact_address": null, "contact_email": "[email protected];[email protected]", "contact_tel": "617-713-8154;", "contact_affiliation": null, "inclusion_criteria": "<br> MS Group Inclusion criteria\r<br>\r<br> -diagnosis of multiple sclerosis and present to the neurology clinic for a regular checkup\r<br> or are admitted to the inpatient floor with acute symptoms.\r<br>\r<br> Exclusion criteria\r<br>\r<br> - Have an active infection\r<br>\r<br> - Take T cell modulating drugs\r<br>\r<br> Control Group Inclusion criteria -scheduled for elective surgery\r<br>\r<br> - without any immunological diseases. Exclusion criteria\r<br>\r<br> - Have an active infection.\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis", "intervention": "Other: Blood Sample", "primary_outcome": "T cell populations", "secondary_outcome": null, "secondary_id": "IRB-P00037843", "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": 8, "title": "The Effect of Extra Virgin Olive Oil in People With Multiple Sclerosis", "summary": "Condition: Multiple SclerosisIntervention: Dietary Supplement: High Phenolic Extra Virgin Olive OilSponsors : University of Cyprus; World Olive Center for Health; Ellis-Farm, Eliama Daily ValueNot yet recruiting ", "published_date": "2021-01-03T00:00:00Z", "discovery_date": "2021-03-08T13:43:03Z", "link": "https://clinicaltrials.gov/ct2/show/NCT04787497", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT04787497" }, "categories": [], "export_date": "2024-04-27T00:00:00Z", "internal_number": "13524235", "last_refreshed_on": "2023-11-13", "scientific_title": "The Neuropsychological Effects of Extra-Virgin Olive Oil in People With Multiple Sclerosis", "primary_sponsor": "University of Cyprus", "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": "2022-05-01", "target_size": "46", "study_type": "Interventional", "study_design": "Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).", "phase": "N/A", "countries": "Greece", "contact_firstname": null, "contact_lastname": null, "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": null, "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - Clinical diagnosis of MS\r<br>\r<br> - Must be between 18 to 65 years of age\r<br>\r<br> - Both males and females are eligible for participation\r<br>\r<br> - Must have at least five years of education\r<br>\r<br> - Must be fluent in Greek language\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Other neurological, psychiatric or chronic condition\r<br>\r<br> - Enrollment in other trials/drug studies\r<br>\r<br> - Experiencing side effects from previous treatments\r<br>\r<br> - Inadequate visual and auditory acuity\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis", "intervention": "Dietary Supplement: High Phenolic Extra Virgin Olive Oil", "primary_outcome": "Symbol Digits Modalities Test (SDMT);California Verbal Learning Test-Second Edition (CVLT-II);Brief Visuospatial Memory Test-Revised (BVMT-R);Wisconsin Card Sorting Test (WCST);Trail Making Test (TMT);The Vocabulary and Block Design from the Wechsler Adult Intelligence Scale (WAIS);The Digit Span Test (DST) from WAIS;Word List Generation (WLG) Test;Faux Pas Recognition (FPR) Test;Hospital Anxiety and Depression Scale (HADS);Health Status Questionnaire (SF-36);Modified Fatigue Impact Scale (MFIS)", "secondary_outcome": null, "secondary_id": "NEEVOO.MS", "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 } ] }