Trial List
List all clinical trials by discovery date. Accepts regular expressions in search.
GET /trials/?format=api&page=479
{ "count": 4854, "next": "http://api.gregory-ms.com/trials/?format=api&page=480", "previous": "http://api.gregory-ms.com/trials/?format=api&page=478", "results": [ { "trial_id": 80, "title": "Adapting mHealth Technology to Improve Patient Activation", "summary": "Conditions: Spinal Cord Injuries; Stroke; Multiple SclerosisIntervention: Behavioral: Fatigue self-management SMS interventionSponsors : Washington University School of Medicine; The Foundation for Barnes-Jewish HospitalRecruiting ", "published_date": "2021-05-14T00:00:00Z", "discovery_date": "2021-05-19T11:05:28Z", "link": "https://clinicaltrials.gov/show/NCT04893590", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT04893590" }, "categories": [], "export_date": "2024-05-04T00:00:00Z", "internal_number": "12092462", "last_refreshed_on": "2022-04-04", "scientific_title": "Adapting mHealth Technology to Improve Patient Activation and Overall Wellness for Persons With Disabilities", "primary_sponsor": "Washington University School of Medicine", "retrospective_flag": "Yes", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Not recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "N/A", "inclusion_gender": "All", "date_enrollement": "2021-05-14", "target_size": "27", "study_type": "Interventional", "study_design": "Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).", "phase": "N/A", "countries": "United States", "contact_firstname": "", "contact_lastname": "Kerri Morgan, PhD", "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": "Washington University School of Medicine", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - 18 years of age or older\r<br>\r<br> - had disability for at least one year\r<br>\r<br> - score of less than 10 on the Modified Fatigue Impact Scale 5 question (MFIS-5)\r<br>\r<br> - ability to read and speak English at the 6th grade level\r<br>\r<br> - willing to use their own phone and SMS\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - evidence of acute condition (e.g. relapse)\r<br>\r<br> - sleep apnea\r<br>\r<br> - inability to answer interview questions or provide consent\r<br>\r<br> - terminal cancer\r<br>", "exclusion_criteria": null, "condition": "Spinal Cord Injuries;Stroke;Multiple Sclerosis", "intervention": "Behavioral: Fatigue self-management SMS intervention", "primary_outcome": "Patient Activation - change in knowledge, skill and confidence for self-management", "secondary_outcome": "The Patient-Reported Outcomes Measurement Information System (PROMIS) - Fatigue Short Form 8a;The Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Disturbance Short Form 8a", "secondary_id": "202103191", "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": 79, "title": "Evaluation of Clinical, Morphologic and Biochemical Markers in Multiple Sclerosis", "summary": "Condition: Multiple SclerosisIntervention: Other: blood sampleSponsor : Medical University of GrazRecruiting ", "published_date": "2021-04-05T00:00:00Z", "discovery_date": "2021-05-19T11:05:27Z", "link": "https://clinicaltrials.gov/ct2/show/NCT04892134", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT04892134" }, "categories": [], "export_date": "2024-05-04T00:00:00Z", "internal_number": "13507853", "last_refreshed_on": "2023-10-30", "scientific_title": "Evaluation of Clinical, Morphologic and Biochemical Markers in Multiple Sclerosis - MarkMS", "primary_sponsor": "Medical University of Graz", "retrospective_flag": "No", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "85 Years", "inclusion_gender": "All", "date_enrollement": "2019-10-03", "target_size": "500", "study_type": "Observational", "study_design": null, "phase": null, "countries": "Austria", "contact_firstname": "; ;", "contact_lastname": "Christian Enzinger, Prof;Christian Enzinger, Prof.;Christian Enzinger, Prof.", "contact_address": null, "contact_email": ";[email protected];[email protected]", "contact_tel": ";+43/316/ 385-82180;+43/316/ 385-82180", "contact_affiliation": "Medical University of Graz;", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - Patients with suspected or proven multiple sclerosis\r<br>\r<br> - The participants are patients who are in inpatient or outpatient care of the\r<br> Department of Neurology at the Medical University of Graz, Austria\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Excluded from the examinations are all patients for whom an MRI examination is\r<br> impossible or problematic\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis", "intervention": "Other: blood sample", "primary_outcome": "Prediction of EDSS ( Expanded Disability Status Scale) progression by combined markers of the disease", "secondary_outcome": "Prediction of clinical relapses;Conversion from CIS (Clinically Isolated Syndrome) to MS (Multiple Sclerosis) defined by MRI and clinical criteria;Time of transition to progressive form of MS;Neuropsychological progression (decrease in SDMT performance);Increase in morphological damage (lesion load, atrophy)", "secondary_id": "MarkMS", "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": 78, "title": "Investigation of the Effects of Technology Supported Different Physiotherapy Approaches on Patients With Multiple Sclerosis", "summary": "Condition: Multiple SclerosisInterventions: Other: Technology Supported Task-Oriented Circuit Training; Other: Home-based TelerehabilitationSponsor : Hacettepe UniversityActive, not recruiting ", "published_date": "2021-05-18T16:00:00Z", "discovery_date": "2021-05-18T10:30:26Z", "link": "https://clinicaltrials.gov/ct2/show/NCT04891341?cond=Multiple+Sclerosis&amp;sfpd_d=14&amp;sel_rss=new14", "source": "Clinical Trials.gov", "relevant": null, "identifiers": { "nct": "NCT04891341" }, "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": 77, "title": "Holter of Movement in Patients With Multiple Sclerosis in Controlled Environment.", "summary": "Condition: Multiple SclerosisInterventions: Device: Actimyo°; Device: IMUSponsors : Dr. Stéphanie Delstanche; SYSNAV; Centre Hospitalier Universitaire de LiègeActive, not recruiting ", "published_date": "2021-11-03T00:00:00Z", "discovery_date": "2021-05-17T17:47:26Z", "link": "https://clinicaltrials.gov/ct2/show/NCT04888689", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT04888689" }, "categories": [], "export_date": "2024-05-04T00:00:00Z", "internal_number": "13397273", "last_refreshed_on": "2023-10-16", "scientific_title": "Holter of Movement in Patients With Multiple Sclerosis. Acti-SEP Study: Controlled Environment.", "primary_sponsor": "Dr. Stéphanie Delstanche", "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": "2021-02-04", "target_size": "21", "study_type": "Interventional", "study_design": "Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).", "phase": "N/A", "countries": "Belgium", "contact_firstname": "", "contact_lastname": "Margaux Poleur, MD", "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": "CHR Citadelle-CHU liège", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - Confirmed MS diagnosis,\r<br>\r<br> - Over 18 years old,\r<br>\r<br> - Ambulant patients,\r<br>\r<br> - Signed informed consent,\r<br>\r<br> - No clinical and / or radiological relapse within 3 months.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Patients with excessive cognitive disorders, limiting the understanding of task or\r<br> with apparent communication difficulties hindering data collection.\r<br>\r<br> - Any other previous or present pathology having an impact on motor function.\r<br>\r<br> - Recent surgery or trauma (less than 6 months) in the upper or lower limbs\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis", "intervention": "Device: Actimyo°;Device: IMU", "primary_outcome": "95th centile of stride velocity;50th centile of stride velocity;95th centile of stride length;50th centile of stride length;Stance phase time", "secondary_outcome": null, "secondary_id": "ActiSEP. Part 1.", "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": 76, "title": "The Effects of Respiratory-based Telerehabilitaion in Patients With MS", "summary": "Conditions: Multiple Sclerosis; Telerehabilitation; Compliance, PatientIntervention: Other: pulmonory based home exercisesSponsors : Dr. Anıl Tosun; Trakya UniversityEnrolling by invitation ", "published_date": "2021-04-18T00:00:00Z", "discovery_date": "2021-05-14T12:06:26Z", "link": "https://clinicaltrials.gov/show/NCT04887051", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT04887051" }, "categories": [], "export_date": "2024-05-04T00:00:00Z", "internal_number": "10968067", "last_refreshed_on": "2021-05-24", "scientific_title": "The Effects of Respiratory-based Telerehabilitation on Physical Performance and Factors Affecting Compliance in Patients With Multiple Sclerosis", "primary_sponsor": "Dr. Anil Tosun", "retrospective_flag": "No", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Recruiting", "other_records": "No", "inclusion_agemin": "20 Years", "inclusion_agemax": "65 Years", "inclusion_gender": "All", "date_enrollement": "2021-04-16", "target_size": "100", "study_type": "Interventional", "study_design": "Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).", "phase": "N/A", "countries": "Turkey", "contact_firstname": ";", "contact_lastname": "Anil Tosun, Dr.;Hilal Keklicek, Asc.Prof.", "contact_address": null, "contact_email": ";", "contact_tel": ";", "contact_affiliation": "Fenerbahce University;Trakya University", "inclusion_criteria": "<br> Inclusion Criteria: ambulatuar or non -ambulatuar\r<br>\r<br> - All patients with diagnosed with Multiple Sclerosis. (Diagnosis of MS according to the\r<br> revised McDonald Criteria 2017)\r<br>\r<br> - An ability to understand and execute simple instructions.\r<br>\r<br> - Aged 20-65 years old.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - patients with hearing, vision and cognitive problems.\r<br>\r<br> - Pregnancy (self-reported)\r<br>\r<br> - Orthopedic and other neurological disorders affecting upper limb movements (e.g.,\r<br> epileptic seizures)\r<br>\r<br> - Contra-indication to physical activity (e.g., heart failure, severe osteoporosis) MS\r<br> clinical relapse or treatment with corticosteroid therapy within 30 days prior to\r<br> enrollment\r<br>\r<br> - Started or stopped a disease-modifying therapy for MS within 30 days prior to\r<br> enrollment\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis;Telerehabilitation;Compliance, Patient", "intervention": "Other: pulmonory based home exercises", "primary_outcome": "Barthell Scale;Functional Ambulatation Categories;Fatigue Severity Scale", "secondary_outcome": null, "secondary_id": "Fenerbahçe Üniversitesi", "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": 74, "title": "An Examination of Cognitive Fatigue Using Functional Neuroimaging", "summary": "Condition: Multiple Sclerosis, Relapsing-RemittingIntervention: Drug: ZeposiaSponsors : Kessler Foundation; Celgene; Hackensack Meridian Health; St. Barnabas Medical CenterNot yet recruiting ", "published_date": "2021-11-05T00:00:00Z", "discovery_date": "2021-05-13T10:18:31Z", "link": "https://clinicaltrials.gov/ct2/show/NCT04885894", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT04885894" }, "categories": [], "export_date": "2024-05-04T00:00:00Z", "internal_number": "13792462", "last_refreshed_on": "2024-03-11", "scientific_title": "An Examination of Cognitive Fatigue Using Functional Neuroimaging", "primary_sponsor": "Kessler Foundation", "retrospective_flag": "Yes", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "64 Years", "inclusion_gender": "All", "date_enrollement": "2022-01-01", "target_size": "60", "study_type": "Observational", "study_design": null, "phase": null, "countries": "United States", "contact_firstname": "; ;", "contact_lastname": "John DeLuca, PhD;Nancy Moore;Amanda PraSisto", "contact_address": null, "contact_email": ";[email protected];[email protected]", "contact_tel": ";973-324-8450;973-324-3507", "contact_affiliation": "Kessler Foundation;", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - Age between 18-64.\r<br>\r<br> - Relapsing remitting multiple sclerosis\r<br>\r<br> - Been newly prescribed a new disease modifying medication for MS (either Zeposia or\r<br> other high dose oral efficacy medication)\r<br>\r<br> - or healthy volunteer who can speak English fluently.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - History of head injury, stroke, seizures, or any other significant neurological event\r<br> other than MS\r<br>\r<br> - Flare up of MS symptoms within the past month.\r<br>\r<br> - History of significant psychiatric illness (for example, bipolar disorder,\r<br> schizophrenia, or psychosis) or a current diagnosis of Major Depressive Disorder.\r<br>\r<br> - Pacemaker or other implanted electrical device, brain stimulator, aneurysm clip (metal\r<br> clips on the wall of a large artery), metallic prostheses (including metal pins and\r<br> rods, heart valves, and internal hearing aids [cochlear implants]), permanent\r<br> eyeliner, implanted delivery pumps, or shrapnel fragments.\r<br>\r<br> - left handed.\r<br>\r<br> - Not able to have an MRI\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis, Relapsing-Remitting", "intervention": "Drug: Zeposia", "primary_outcome": "Brain activation (BOLD signal)", "secondary_outcome": "Fatigue Onset", "secondary_id": "R-1150-21", "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": 73, "title": "Holter of Movement in Patients With Multiple Sclerosis in Uncontrolled Environment.", "summary": "Condition: Multiple SclerosisIntervention: Device: ActimyoSponsors : Dr. Stéphanie Delstanche; SYSNAV; Centre Hospitalier Universitaire de LiègeRecruiting ", "published_date": "2021-11-03T00:00:00Z", "discovery_date": "2021-05-12T10:42:31Z", "link": "https://clinicaltrials.gov/ct2/show/NCT04882891", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT04882891" }, "categories": [], "export_date": "2024-05-04T00:00:00Z", "internal_number": "13913769", "last_refreshed_on": "2024-04-29", "scientific_title": "Holter of Movement in Patients With Multiple Sclerosis. Acti-SEP Study: Uncontrolled Environment.", "primary_sponsor": "Centre Hospitalier Universitaire de Liege", "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": "2021-03-09", "target_size": "80", "study_type": "Interventional", "study_design": "Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).", "phase": "N/A", "countries": "Belgium", "contact_firstname": "", "contact_lastname": "Margaux Poleur, MD", "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": "CHR Citadelle-CHU liège", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - Confirmed MS diagnosis,\r<br>\r<br> - Over 18 years old,\r<br>\r<br> - Ambulant patients,\r<br>\r<br> - Signed informed consent,\r<br>\r<br> - No clinical and / or radiological relapse within 3 months.\r<br>\r<br> - EDSS < or = à 5,5,\r<br>\r<br> - Treated patient must be on a stable regimen dose and molecule for at least 2 month\r<br> prior to inclusion.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Patients with excessive cognitive disorders, limiting the understanding of task or\r<br> with apparent communication difficulties hindering data collection.\r<br>\r<br> - Any other previous or present pathology having an impact on motor function.\r<br>\r<br> - Recent surgery or trauma (less than 6 months) in the upper or lower limbs\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis", "intervention": "Device: Actimyo", "primary_outcome": "95th centile of stride velocity;50th centile of stride velocity;95th centile of stride length;50th centile of stride length;Stance phase time", "secondary_outcome": null, "secondary_id": "ActiSEP. Part 2.", "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": 72, "title": "Sport, Rehabilitation and Nutrition in Multiple Sclerosis: The LINUS Project", "summary": "Condition: Multiple SclerosisIntervention: Behavioral: B-HIPE (Brief High Impact Preparatory Experience)Sponsor : Fondazione Don Carlo Gnocchi OnlusRecruiting ", "published_date": "2021-04-28T00:00:00Z", "discovery_date": "2021-05-11T11:06:31Z", "link": "https://clinicaltrials.gov/show/NCT04881422", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT04881422" }, "categories": [], "export_date": "2024-05-04T00:00:00Z", "internal_number": "10944900", "last_refreshed_on": "2021-05-17", "scientific_title": "Sport, Rehabilitation and Nutrition in Multiple Sclerosis: An Innovative Multidisciplinary High Impact Intervention for the Lifestyle Change", "primary_sponsor": "Fondazione Don Carlo Gnocchi Onlus", "retrospective_flag": "No", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "70 Years", "inclusion_gender": "All", "date_enrollement": "2018-07-15", "target_size": "30", "study_type": "Interventional", "study_design": "Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).", "phase": "N/A", "countries": "Italy", "contact_firstname": ";", "contact_lastname": "Laura LM Mendozzi, MD;Laura Mendozzi, MD", "contact_address": null, "contact_email": "[email protected];[email protected]", "contact_tel": "02 40308571;", "contact_affiliation": null, "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - aged 18 to 70 years\r<br>\r<br> - EDSS ranging from 1 to 7.5.\r<br>\r<br> - pwMS with who are on a western diet\r<br>\r<br> - stabilized medical therapy and clinical conditions\r<br>\r<br> - pwMS with a motor control of upper limbs sufficient to maneuver a tiller\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Heavy smoking, alcohol and drugs abuse\r<br>\r<br> - severe cognitive impairment\r<br>\r<br> - dysphagia and/or comorbidities requiring protected environments and specific medical\r<br> assistance\r<br>\r<br> - blindness and severe visual disturbances (included severe nystagmus)\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis", "intervention": "Behavioral: B-HIPE (Brief High Impact Preparatory Experience)", "primary_outcome": "FS-36 Health Related Quality of Life (HRQoL);The Fatigue Severity Scale (FSS);Food frequency questionnaire (FFQ)", "secondary_outcome": "MSIS29- Multiple Sclerosis Impact Scale;MOS Sleep Scale (MOSS);Restless Legs Scale (RLS);Six minute walking test (6MWT);Hospital Anxiety and Depression Scale (HADS)", "secondary_id": "07_23/05/2018", "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": 71, "title": "Tenofovir Alafenamide for Treatment of Symptoms and Neuroprotection in Relapsing Remitting Multiple Sclerosis", "summary": "Conditions: Multiple Sclerosis, Relapsing-Remitting; FatigueInterventions: Drug: TENOFOVIR ALAFENAMIDE FUMARATE 25 Mg ORAL TABLET [VEMLIDY]; Drug: PlaceboSponsors : Harvard Medical School; Gilead SciencesNot yet recruiting ", "published_date": "2021-04-30T00:00:00Z", "discovery_date": "2021-05-10T12:29:31Z", "link": "https://clinicaltrials.gov/show/NCT04880577", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT04880577" }, "categories": [], "export_date": "2024-05-04T00:00:00Z", "internal_number": "12702509", "last_refreshed_on": "2022-11-28", "scientific_title": "Tenofovir Alafenamide for Treatment of Symptoms and Neuroprotection in Relapsing Remitting Multiple Sclerosis", "primary_sponsor": "Massachusetts General Hospital", "retrospective_flag": "Yes", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Not recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "N/A", "inclusion_gender": "All", "date_enrollement": "2022-09-15", "target_size": "0", "study_type": "Interventional", "study_design": "Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).", "phase": "Phase 2", "countries": "United States", "contact_firstname": "", "contact_lastname": "Michael Levy, MD, PhD", "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": "Massachusetts General Hospital", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> 1. Provision of signed and dated informed consent form\r<br>\r<br> 2. Stated willingness and ability to comply with all study procedures and availability\r<br> for the duration of the study\r<br>\r<br> 3. Aged 18+ years\r<br>\r<br> 4. Diagnosis of MS using revised 2010 McDonald criteria of clinically definite MS.\r<br>\r<br> 5. Receiving treatment with either ocrelizumab or rituximab on a regular twice-yearly\r<br> schedule. The first infusion must have been received at least 6 months before\r<br> enrollment.\r<br>\r<br> 6. Must report significant fatigue during the past 3 months not due to a cause other than\r<br> MS.\r<br>\r<br> 7. For females of reproductive potential: use of highly effective contraception for at\r<br> least 1 month prior to screening and agreement to use such a method during study\r<br> participation.\r<br>\r<br> 8. For males of reproductive potential: use of condoms or other methods to ensure\r<br> effective contraception with partner.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> 1. Pregnancy or lactation\r<br>\r<br> 2. Known allergic reactions to components of TAF\r<br>\r<br> 3. Treatment with another investigational drug or other MS-directed intervention such as\r<br> glatiramer acetate, or dimethyl fumarate within 3 months\r<br>\r<br> 4. Positive HIV antibody test, active or latent hepatitis B\r<br>\r<br> 5. Relapse and/or steroid treatment within the previous 30 days\r<br>\r<br> 6. Baseline EDSS > 7\r<br>\r<br> 7. Current symptoms of severe, progressive, or uncontrolled renal, hematologic,\r<br> gastrointestinal, pulmonary, cardiac, or neurologic disease, or other medical\r<br> conditions that, in the opinion of the Investigator, might place the subject at\r<br> unacceptable risk for participation in this study\r<br>\r<br> 8. Known history of sleep apnea, narcolepsy, or other significant sleep disorders\r<br>\r<br> 9. Recent changes to medications affecting sleep or fatigue or changes in dosage of those\r<br> medications within 90 days\r<br>\r<br> 10. Creatinine clearance (CrCl) <55mL/min, as calculated by the Cockcroft-Gault equation\r<br>\r<br> 11. Taking medication with known interactions with tenofovir alafenamide including:\r<br> Acyclovir, valacyclovir, adefovir, cabozantinib, carbamazepine, cidofovir, cladribine,\r<br> cobicistat, diclofenac, multiple NSAIDs or chronic high dose NSAIDs, fosphenytoin or\r<br> phenytoin, ganciclovir, valganciclovir, oxcarbazepine, phenobarbital, primidone,\r<br> rifabutin, rifampin, rifapentine, sofosbuvir, tipranavir\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis, Relapsing-Remitting;Fatigue", "intervention": "Drug: TENOFOVIR ALAFENAMIDE FUMARATE 25 Mg ORAL TABLET [VEMLIDY];Drug: Placebo", "primary_outcome": "Number of participants with treatment-related adverse events as assessed by CTCAE v4.0;Modified Fatigue Impact Scale;serum concentrations of neurofilament light chains (NfL)", "secondary_outcome": "Multiple Sclerosis Impact Scale-29;Short Form 36 Health Survey Questionnaire;Beck Depression Inventory;Perceived Deficits Questionnaire;Annualized relapse rate;Expanded Disability Status Scale;Symbol Digit Modality Test;Timed 25 Foot Walk;9-Hole Peg Test;Number of new MRI lesions;EBV viral load;EBV titers", "secondary_id": "2020P003311", "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": 70, "title": "Proof-of-concept Study for SAR441344 (Frexalimab) in Relapsing Multiple Sclerosis", "summary": "Condition: Multiple SclerosisInterventions: Drug: SAR441344 IV; Drug: placebo IV; Drug: SAR441344 SC; Drug: placebo SC; Drug: MRI contrast-enhancing preparationsSponsor : SanofiRecruiting ", "published_date": "2021-06-05T00:00:00Z", "discovery_date": "2021-05-10T12:29:31Z", "link": "https://clinicaltrials.gov/ct2/show/NCT04879628", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT04879628" }, "categories": [ { "category_id": 41, "category_description": "Sanofi has reported positive new data from a mid-stage study of its investigational anti-CD40L antibody in patients with relapsing multiple sclerosis (MS).\n\nResults from the phase 2 study, being presented at the 2023 Consortium of Multiple Sclerosis Centers annual meeting, demonstrate that frexalimab significantly reduced disease activity in patients with relapsing forms of the disease.\n\nSource: https://www.sanofi.com/en/media-room/press-releases/2023/2023-05-31-05-00-00-2678991", "category_name": "Frexalimab", "category_slug": "frexalimab", "category_terms": [ "frexalimab", "SAR441344" ], "article_count": 2 } ], "export_date": "2024-05-04T00:00:00Z", "internal_number": "13704229", "last_refreshed_on": "2024-02-27", "scientific_title": "A Phase 2, Double-blind, Randomized, Placebo-controlled Study Assessing Efficacy and Safety of SAR441344, a CD40L-antagonist Monoclonal Antibody, in Participants With Relapsing Multiple Sclerosis", "primary_sponsor": "Sanofi", "retrospective_flag": "Yes", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Not recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "55 Years", "inclusion_gender": "All", "date_enrollement": "2021-06-07", "target_size": "129", "study_type": "Interventional", "study_design": "Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).", "phase": "Phase 2", "countries": "United States;Bulgaria;Canada;Czechia;France;Germany;Russian Federation;Spain;Turkey;Ukraine;Bulgaria;Canada;Czechia;France;Germany;Russian Federation;Spain;Turkey;Ukraine;United States", "contact_firstname": "", "contact_lastname": "Clinical Sciences & Operations", "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": "Sanofi", "inclusion_criteria": "<br> Inclusion criteria:\r<br>\r<br> - Participant must be 18 to 55 years of age inclusive, at the time of signing the\r<br> informed consent.\r<br>\r<br> - The participant must have been diagnosed with RMS (relapsing-remitting MS and\r<br> secondary progressive MS participants with relapses) according to the 2017 revision of\r<br> the McDonald diagnostic criteria.\r<br>\r<br> - The participant must have at least 1 documented relapse within the previous year, or\r<br> =2 documented relapses within the previous 2 years, or =1 active Gd-enhancing brain\r<br> lesion on an MRI scan in the past 6 months and prior to screening.\r<br>\r<br> - Body weight within 45 to 120 kg (inclusive) and body mass index (BMI) within the range\r<br> 18.0 to 35.0 kg/m2 (inclusive) at Screening.\r<br>\r<br> - Contraceptive use by men and women should be consistent with local regulations\r<br> regarding the methods of contraception for those participating in clinical studies.\r<br>\r<br> - Capable of giving signed informed consent.\r<br>\r<br> Exclusion criteria:\r<br>\r<br> - The participant has been diagnosed with PPMS according to the 2017 revision of the\r<br> McDonald diagnostic criteria or with non-relapsing SPMS.\r<br>\r<br> - The participant has conditions or situations that would adversely affect participation\r<br> in this study.\r<br>\r<br> - The participant has a history of or currently has concomitant medical or clinical\r<br> conditions that would adversely affect participation in this study.\r<br>\r<br> - History, clinical evidence, suspicion or significant risk for thromboembolic events,\r<br> as well as myocardial infarction, stroke and/or antiphosholipid syndrome and any\r<br> participants requiring antithrombotic treatment.\r<br>\r<br> - Allergies to humanized monoclonal antibodies or severe post-treatment hypersensitivity\r<br> reactions other than localized injection site reaction, to any biological molecule.\r<br>\r<br> - The participant has received any of the forbidden medications/treatments within the\r<br> specified time frame before any baseline assessment.\r<br>\r<br> - The participant has taken other investigational drug within 3 months or 5-half-live,\r<br> whichever is longer, before the screening visit.\r<br>\r<br> - The participant has an EDSS score >5.5 at the first screening visit.\r<br>\r<br> - The participant has had a relapse in the 30 days prior to randomization.\r<br>\r<br> - Positive human immunodeficiency virus (HIV) serology (anti HIV1 and anti HIV2\r<br> antibodies) or a known history of HIV infection, active or in remission.\r<br>\r<br> - Abnormal laboratory test(s) at Screening.\r<br>\r<br> - Presence of Hepatitis B surface antigen (HBsAg) or anti-Hepatitis B core antibodies\r<br> (anti-HBc Ab) at screening or within 3 months prior to first dose of study\r<br> intervention.\r<br>\r<br> - Positive Hepatitis C antibody test result at screening or within 3 months prior to\r<br> starting study intervention.\r<br>\r<br> The above information is not intended to contain all considerations relevant to a patient's\r<br> potential participation in a clinical trial.\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis", "intervention": "Drug: SAR441344 IV;Drug: placebo IV;Drug: SAR441344 SC;Drug: placebo SC;Drug: MRI contrast-enhancing preparations", "primary_outcome": "Number of new Gadolinium (Gd)-enhancing T1-hyperintense (GdE T1) lesions", "secondary_outcome": "Number of new or enlarging T2 lesions;Total number of GdE T1 lesions;Adverse events (AEs) and serious adverse events (SAEs);Antidrug antibodies (ADA);Pharmacokinetic (PK) parameters: Cmax;PK parameter: tmax;PK parameter: AUC0-tau;PK parameter: t1/2z", "secondary_id": "U1111-1260-3962;2020-004785-19;ACT16877", "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 } ] }