Trial List
List all clinical trials by discovery date. Accepts regular expressions in search.
GET /trials/?format=api&page=5
{ "count": 4854, "next": "http://api.gregory-ms.com/trials/?format=api&page=6", "previous": "http://api.gregory-ms.com/trials/?format=api&page=4", "results": [ { "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": 107 } ], "export_date": "2024-05-04T00:00:00Z", "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": 107 } ], "export_date": "2024-05-04T00:00:00Z", "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": "2024-05-04T00:00:00Z", "internal_number": "13939198", "last_refreshed_on": "2024-04-30", "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": "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.;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_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": "2024-05-04T00:00:00Z", "internal_number": "13903128", "last_refreshed_on": "2024-04-22", "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": "2024-05-04T00:00:00Z", "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": "2024-05-04T00:00:00Z", "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 }, { "trial_id": 4326, "title": "Yoga for Multiple Sclerosis", "summary": null, "published_date": "2024-04-03T00:00:00Z", "discovery_date": "2024-04-08T17:13:41.705850Z", "link": "http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=100747", "source": "WHO XML import", "relevant": null, "identifiers": {}, "categories": [], "export_date": "2024-05-04T00:00:00Z", "internal_number": "13830450", "last_refreshed_on": "2024-04-01", "scientific_title": "Effect of Yoga therapy on Autonomic Functions in Multiple Sclerosis: A Randomized Controlled Trial - NIL", "primary_sponsor": "National Institute of Mental Health and Neurosciences NIMHANS", "retrospective_flag": "Yes", "date_registration": null, "source_register": "CTRI", "recruitment_status": "Not Recruiting", "other_records": "No", "inclusion_agemin": null, "inclusion_agemax": null, "inclusion_gender": null, "date_enrollement": "2024-03-13", "target_size": "80", "study_type": "Interventional", "study_design": "Randomized, Parallel Group, Active Controlled Trial Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Outcome Assessor Blinded", "phase": "Phase 4", "countries": "India", "contact_firstname": "Kankan Gulati", "contact_lastname": null, "contact_address": "Department of Integrative Medicine, National Institute of Mental Health and Neurosciences (NIMHANS), Bangalore", "contact_email": "[email protected]", "contact_tel": "8762019348", "contact_affiliation": "National Institute of Mental Health and Neurosciences (NIMHANS)", "inclusion_criteria": "Inclusion criteria: Patients with Relapsing-Remitting Multiple sclerosis (RRMS) on disease-modifying agents (DMAs), Aged between 18-50 years, EDSS less than 5, Patients who have never done Yoga before, Patients who have access to a smartphone, tablet or laptop with internet connectivity. <br/ ><br>", "exclusion_criteria": "Exclusion criteria: Progressive course of MS, Patients with concomitant /associated etiologies that could affect cognition and behavioural changes like alcoholism, psychiatric disturbances unrelated to MS, an independent psychiatric disorder, cardiac rhythm disturbances, metabolic and medical cardiac disorders which affect HRV, B12 deficiency, Any ectopic beats or artefact in the HRV recording, pregnancy, Previous head trauma, Patients with profound cognitive impairment (MMSE less than 23). <br/ ><br>", "condition": "Health Condition 1: G35- Multiple sclerosis", "intervention": "Intervention1: Yoga: Live supervised direct + tele-yoga sessions will be offered five days/ week for 24 weeks (Total 120 sessions)<br>Control Intervention1: Physiotherapy: Live supervised direct + tele-physiotherapy sessions will be offered five days/ week for 24 weeks (Total 120 sessions)<br>", "primary_outcome": "To examine the effect of add-on yoga intervention on autonomic functions using HRV in patients with MS.Timepoint: Baseline and 24 weeks post-intervention", "secondary_outcome": "To assess the effects of add-on yoga intervention on depression, anxiety and QOL in patients with MS using Montgomery and Asberg Depression Rating Scale (MADRS), State-Trait Anxiety Inventory (STAI) and Multiple Sclerosis Impact Scale (MSIS-29) respectively.Timepoint: Baseline, 12 weeks and 24 weeks post-intervention;To correlate the change in the clinical variables with the change in the immune parameters.Timepoint: Baseline and 24 weeks post-intervention;To evaluate the effect of add-on yoga intervention on autonomic functions using Composite Autonomic Symptom Scale-31 (COMPASS-31) in patients with MS.Timepoint: Baseline, 12 weeks and 24 weeks post-intervention;To evaluate the effect of add-on yoga intervention on autonomic functions using Ewing’s battery in patients with MS.Timepoint: Baseline and 24 weeks post-intervention;To record the effects of add-on yoga intervention on the number and frequency of relapses in patients with MS.Timepoint: Baseline and 24 weeks post-intervention;To study the effects of add-on yoga intervention on fatigue, pain and disability in patients with MS using Fatigue Assessment Scale (FAS), Visual Analog Scale (VAS) and Expanded Disability Status Scale (EDSS) respectively.Timepoint: Baseline, 12 weeks and 24 weeks post-intervention;To study the effects of add-on yoga intervention on peripheral blood cytokines namely TNF-a, IL-6, IL-10 and IL-12p40 in patients with MS.Timepoint: Baseline and 24 weeks post-intervention", "secondary_id": "NIL", "source_support": "National Institute of Mental Health and Neurosciences (NIMHANS)", "ethics_review_status": "Approved", "ethics_review_approval_date": "2024-07-02", "ethics_review_contact_name": null, "ethics_review_contact_address": "Human Ethics Committee for Research in AYUSH and Integrative Medicine", "ethics_review_contact_phone": null, "ethics_review_contact_email": null, "results_date_completed": null, "results_url_link": null }, { "trial_id": 4325, "title": "Bioequivalence study of Cladribine 10 mg tablet in relapsing forms of multiple sclerosis patients", "summary": null, "published_date": "2024-06-03T00:00:00Z", "discovery_date": "2024-04-08T17:13:41.602540Z", "link": "http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=99897", "source": "WHO XML import", "relevant": null, "identifiers": {}, "categories": [], "export_date": "2024-05-04T00:00:00Z", "internal_number": "13926419", "last_refreshed_on": "2024-04-29", "scientific_title": "A Prospective, Randomized, Open Label, Balanced, Single Dose, Two Stage, Two-Treatment, Two-Period, Two-Sequence, Crossover Bioequivalence Study of Cladribine Tablet (Intas \nPharmaceuticals Ltd.) Compared with Mavenclad® (EMD Serono, Inc.) in Patients with Relapsing \nForms of Multiple Sclerosis. - NIL", "primary_sponsor": "Invitro Research Solutions Private Limited", "retrospective_flag": "Yes", "date_registration": null, "source_register": "CTRI", "recruitment_status": "Not Recruiting", "other_records": "No", "inclusion_agemin": null, "inclusion_agemax": null, "inclusion_gender": null, "date_enrollement": "2024-03-21", "target_size": "30", "study_type": "BA/BE", "study_design": "Randomized, Crossover Trial Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Open Label", "phase": "N/A", "countries": "India", "contact_firstname": "T Vijaya Bhaskar", "contact_lastname": null, "contact_address": "Invitro Research Solutions Pvt. Ltd, Clinical Development\nDepartment, Clinical Operations Division, 2nd Floor No. 22 & 23, Kodigehalli Main Road, Sahakar Nagar Post, Hebbal,", "contact_email": "[email protected]", "contact_tel": "6366947473", "contact_affiliation": "Invitro Research Solutions Pvt. Ltd.,", "inclusion_criteria": "Inclusion criteria: 1 Participant must sign an ICF indicating that the participant understands the purpose of, and procedures required for the study and in this protocol and is willing to participate in the study. <br/ ><br>2 Man or woman participant must be greater than or equal to 18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place), at the time of signing the informed consent. <br/ ><br>3 Body weight greater than or equal to 40 Kg <br/ ><br>4 Participants with relapsing forms of multiple sclerosis including relapsing-remitting disease and active secondary progressive disease as per McDonald’s criteria, who are eligible and planned <br/ ><br>to receive for the first cycle of either first or second treatment course of oral cladribine tablet as per investigator judgement. <br/ ><br>NOTE: If a participant is receiving their Second Course/First Cycle of oral cladribine under <br/ ><br>current study, then it must be at least 43 weeks after the last dose of First Course/Second Cycle. <br/ ><br>5 A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: <br/ ><br>a. Is not a woman of childbearing potential (WOCBP) <br/ ><br>OR <br/ ><br>a. Is a WOCBP and agrees to remain on an acceptable contraceptive method that is highly <br/ ><br>effective (with a failure rate of less than 1% per year), with low user dependency when used <br/ ><br>consistently and correctly <br/ ><br>b. during the intervention phase and for at least 6 months after the last dose of study <br/ ><br>intervention and agrees not to donate eggs (ova, oocytes) for the purpose of <br/ ><br>reproduction during the study and for a period of at least 6 months after the last dose <br/ ><br>of study intervention. The investigator should evaluate the effectiveness and the <br/ ><br>potential for contraceptive method failure (e.g., noncompliance, recently initiated) of <br/ ><br>the contraceptive method in relationship to the first dose of study intervention. <br/ ><br>c. A WOCBP must have a negative highly sensitive serum pregnancy test at screening <br/ ><br>and urine pregnancy test before each dosing. <br/ ><br>d. If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum <br/ ><br>pregnancy test is required. In such cases, the participant must be excluded from <br/ ><br>participation if the serum pregnancy result is positive <br/ ><br>The investigator is responsible for review of medical history, menstrual history, and recent <br/ ><br>sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. <br/ ><br>6 Male participants are eligible to participate if they agree to the following during the intervention phase and for at least 6 months after the last dose of study intervention: <br/ ><br>a. Must agree not to donate sperm for the purpose of reproduction <br/ ><br>PLUS EITHER: <br/ ><br>b. Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent <br/ ><br>on a long-term and persistent basis) and agree to remain abstinent <br/ ><br>OR <br/ ><br>a. Must agree to use contraception /barrier as detailed below <br/ ><br>b. A male participant must wear a condom when engaging in any activity that allows for <br/ ><br>passage of ejaculate to another person. <br/ ><br>c. Male participants should also be advised of the benefit for a female partner to use a <br/ ><br>highly effective method of contraception as condom may break or leak when having <br/ ><br>sexual intercourse", "exclusion_criteria": "Exclusion criteria: 1 Documented medical history of uncontrolled, clinically significant intercurrent cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances or any other medical condition(s) for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments. <br/ ><br>2 Known allergies, hypersensitivity, or intolerance to any of the study interventions, or components/excipients thereof (refer to the US prescribing information of Mavenclad), or drug or other allergy that, in the opinion of the investigator, contraindicates participation in the study. <br/ ><br>3 Contraindications to the use of study intervention per latest US prescribing information of Mavenclad <br/ ><br>4 Current unstable liver or biliary disease with Child-Pugh score less than 6 at screening visit. <br/ ><br>5 Participant with clinically significant current cardiac conditions like serious cardiac arrhythmia not controlled by adequate medication, electrocardiographic evidence of acute ischemic abnormalities, or any other cardiac illness that could lead to a safety risk to the participant in the opinion of the investigator. <br/ ><br>6 Positive for HIV, or positive Hepatitis C antibody test or Hepatitis B surface antigen test and/or core antibody test for IgG and/or IgM. <br/ ><br>7 Evidence of active or latent tuberculosis (TB) as detected by local standard of practice such as imaging and/or positive QuantiFERON-TB Gold test. <br/ ><br>8 Presence of any clinically significant active systemic bacterial, viral or fungal infections (acute or chronic) as assessed by investigator at randomization. Randomization can be delayed till resolution or control of infection as assessed by investigator allowing use of cladribine tablet. <br/ ><br>9 Live or live-attenuated vaccine(s) within 6 weeks prior to randomization, or plans to receive such vaccines during the study. Participants must agree to avoid live or live-attenuated vaccine(s) after study till white blood cell counts are within normal limits. <br/ ><br>10 Current evidence or history of malignancy within the past 3 years except for (a) basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of disease for 3 years; or (b) any malignancy which is considered cured with minimal risk of recurrence AND whose natural history or treatment does not have the potential as judged by the investigator to interfere with the safety of the study intervention are eligible for this study. <br/ ><br>11 Participants with neurological findings consistent with progressive multifocal leukoencephalopathy (PML), or confirmed PML. Baseline MRI is required during screening period if not done in past 3 months prior to administration of study intervention if it is the participant’s first treatment course. <br/ ><br>12 Received a study intervention or used an invasive investigational medical device within 30 days or 5 half-lives prior to randomization, whichever is longer. <br/ ><br>13 Participant’s clinical condition would not be feasible for pharmacokinetic assessment as determined by investigator. <br/ ><br>14 Unable to swallow solid, oral dosage forms whole with the aid of water (participants must not chew, divide, dissolve, or crush the study intervention) <br/ ><br>", "condition": "Health Condition 1: G35- Multiple sclerosis", "intervention": "Intervention1: Cladribine tablet 10 mg: Manufactured by: Intas <br>Pharmaceuticals Limited India<br>The recommended cumulative dosage of cladribine tablet is 3.5 mg per kg body <br>weight administered orally and divided into 2 yearly treatment courses (1.75 mg per <br>kg per treatment course). Each treatment course is divided into 2 treatment cycles: Each cycle lasting 4 to 5 consecutive days. Do not administer more <br>than 20 mg/day.<br>Control Intervention1: MAVENCLAD® (Cladribine) tablets <br>10 mg: Manufactured for: : EMD Serono, Inc., Rockland, MA 02370.<br>The recommended cumulative dosage of cladribine tablet is 3.5 mg per kg body weight administered orally and divided into 2 yearly treatment courses (1.75 mg per kg per treatment course). Each treatment course is divided into 2 treatment cycles: Each cycle lasting 4 to 5 consecutive days. Do not administer more than 20 mg/day.<br>", "primary_outcome": "Following primary pharmacokinetic parameters <br/ ><br>will be assessed: <br/ ><br>a. Cmax and AUC0-tTimepoint: After First Dose", "secondary_outcome": "Following secondary pharmacokinetic <br/ ><br>parameters will be assessed: <br/ ><br>a. AUC0-8, Tmax, AUC_% Exp, R2 <br/ ><br>adjusted, ?z, <br/ ><br>t1/2Timepoint: After First Dose;Frequency and/or incidence of adverse <br/ ><br>events (AE) and Serious Adverse Events <br/ ><br>(SAE)Timepoint: For entire study", "secondary_id": "iVRS-CD-23-069_Version 01, Dated 29 Dec 2023", "source_support": "Intas Pharmaceuticals Limited,\nCorporate House, Near Sola Bridge, S.G. Highway, Thaltej, Ahmedabad – 380054, Gujarat, India.", "ethics_review_status": "Approved;Approved;Approved;Approved", "ethics_review_approval_date": null, "ethics_review_contact_name": ";;;", "ethics_review_contact_address": "Independent Ethics Committee Namaste Integrated Services;Institutional Ethics Committee, Saideep Hospital;Penta-Med Ethics Committee;Rajalakshmi Hospital Institutional Ethics Committee", "ethics_review_contact_phone": ";;;", "ethics_review_contact_email": ";;;", "results_date_completed": null, "results_url_link": null }, { "trial_id": 4324, "title": "Ifenprodil as a ReMyelinating repurpOsed Drug in Multiple Sclerosis", "summary": "<b>Conditions</b>: Multiple Sclerosis; Remitting Relapsing Multiple Sclerosis\n<br /><b>Interventions</b>: Drug: Ifenprodil; Drug: Placebo\n<br /><b>Sponsors</b>: Assistance Publique - Hôpitaux de Paris\n<br /><b>Not yet recruiting</b>", "published_date": "2024-12-03T00:00:00Z", "discovery_date": "2024-04-08T17:13:41.547385Z", "link": "https://clinicaltrials.gov/ct2/show/NCT06330077", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT06330077", "euct": null, "eudract": null }, "categories": [], "export_date": "2024-05-04T00:00:00Z", "internal_number": "13828857", "last_refreshed_on": "2024-04-01", "scientific_title": "A Phase 2 Trial Assessing Ifenprodil as a ReMyelinating repurpOsed Drug in Multiple Sclerosis", "primary_sponsor": "Assistance Publique - Hôpitaux de Paris", "retrospective_flag": "No", "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": "2024-03-04", "target_size": "60", "study_type": "Interventional", "study_design": "Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).", "phase": "Phase 2", "countries": "France", "contact_firstname": "", "contact_lastname": "Bruno STANKOFF, MD", "contact_address": null, "contact_email": "[email protected]", "contact_tel": "0171970659", "contact_affiliation": null, "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> -\r<br>\r<br> Patients:\r<br>\r<br> 1. Signed informed consent form at pre-inclusion visit\r<br>\r<br> 2. Age between 18 years and 55 years, inclusive, at time of pre-inclusion visit.\r<br>\r<br> 3. Patient with a RR form of MS according McDonald criteria 2017 at pre-inclusion visit\r<br>\r<br> 4. Able to comply with the study protocol and to understand the purpose and risks of the\r<br> study, in the investigator's judgment\r<br>\r<br> 5. Social security registration (AME excluded) at time of pre-inclusion visit\r<br>\r<br> 6. At least one eye with a P100 latency > 118ms on visual evoked potential at baseline\r<br> (defining the qualifying eye) at time of pre-inclusion visit\r<br>\r<br> 7. Retinal nerve fibre layer thickness on spectral-domain optical coherence tomography\r<br> [OCT] > 70 µm in the VEP qualifying eye (to increase the likelihood that the number of\r<br> surviving axons is sufficient to provide the substrate for remyelination to occur) at\r<br> time of pre-inclusion visit\r<br>\r<br> 8. Patient under disease modifying therapy (first or second line approved immune active\r<br> therapy) or patient without any DMT at time of pre-inclusion visit\r<br>\r<br> 9. EDSS score = 6 at time of pre-inclusion visit\r<br>\r<br> 10. For women of childbearing potential : Efficient contraception include oral\r<br> contraception, intrauterine devices hormonal device, intrauterine hormone-releasing\r<br> system, sterilization method and other forms of contraception with failure rate <1%)\r<br>\r<br> - Healthy Volunteers\r<br>\r<br> 1. Signed informed consent form 2. Age between 18 years and 55 years, inclusive 3. All\r<br> female subjects of childbearing potential must practice effective contraception include\r<br> oral contraception, intrauterine devices hormonal device, intrauterine hormone-releasing\r<br> system, sterilization method and other forms of contraception with failure rate <1%) 4.\r<br> Able to comply with the study protocol, in the investigator's judgment 5. Social security\r<br> registration (AME excluded)\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> Patients\r<br>\r<br> 1. Patient with an acute NORB in the last 6 months prior to pre-inclusion visit\r<br>\r<br> 2. Patient with a clinical relapse other than NORB in the last 6 months prior to\r<br> pre-inclusion visit\r<br>\r<br> 3. Patients having received methylprednisolone infusion in the last 4 weeks prior to\r<br> pre-inclusion visit\r<br>\r<br> 4. Contraindications to investigational medicinal products (ifenprodil/placebo) and to\r<br> auxiliary medicinal products (gadolinium, [18F]-florbetaben)\r<br>\r<br> 5. Inability to complete an MRI (contraindications for MRI include but are not restricted\r<br> to weight = 140 kg, pacemaker, cochlear implants, presence of foreign substances in\r<br> the eye, intracranial vascular clips, surgery within 6 weeks of entry into the study,\r<br> coronary stent implanted within 8 weeks prior to the time of the intended MRI,\r<br> contraindication to gadoteric acid etc.).\r<br>\r<br> 6. PET imaging performed in the past 12 months as part of clinical research\r<br>\r<br> 7. History or incidental discovery of significant cardiac conduction block\r<br>\r<br> 8. Orthostatic hypotension Syndrome define as a drop of > 20 mmHg in systolic, and/or >\r<br> 10 mmHg in diastolic between lying down and immediate standing\r<br>\r<br> 9. Known long QT syndrome or long QT syndrome (the limit is defined at 450 ms on\r<br> corrected QT) highlighted during the pre-inclusion visit\r<br>\r<br> 10. Any uncontrolled general (cancer, infectious, hematologic, hepatic, immunologic,\r<br> endocrinologic, neurologic, dermatologic, psychiatric, allergic, renal, or\r<br> cardiovascular) disease.\r<br>\r<br> 11. Creatinine clearance < 60 ml/min at pre-inclusion visit\r<br>\r<br> 12. ASAT, ALAT of alkaline phosphatase > 3-fold the upper limit normal at pre-inclusion\r<br> visit\r<br>\r<br> 13. Know Galactosemia, glucose malabsorption or lactase deficiency\r<br>\r<br> 14. Known of lack of peripheral venous access or lack of peripheral venous access\r<br> highlighted during the pre-inclusion visit\r<br>\r<br> 15. Thrombocytopenia with platelets < 100 000/mm3\r<br>\r<br> 16. Pregnancy and/or lactating women\r<br>\r<br> 17. Legal protection (curatorship or tutorship)\r<br>\r<br> 18. Deprive of freedom or under security measure\r<br>\r<br> 19. Participation in another interventional trial evaluating a health product or any\r<br> randomized trial or being in the exclusion period at the end of a previous study\r<br>\r<br> 20. Refusal to be informed in case of clinically significant incidental discovery after\r<br> MRI\r<br>\r<br> 21. Patient treated for hypertension with the following drugs blocking the\r<br> alpha-adrenergic system either in periphery (prazosine, urapidil, moxisylyte,\r<br> labetalol) or centrally (clonidine, monoxidine, methyldopa)\r<br>\r<br> Healthy Volunteers\r<br>\r<br> 1. Inability to complete an MRI (contraindications for MRI include but are not restricted\r<br> to weight = 140 kg, pacemaker, cochlear implants, presence of foreign substances in\r<br> the eye, intracranial vascular clips, surgery within 6 weeks of entry into the study,\r<br> coronary stent implanted within 8 weeks prior to the time of the intended MRI, etc).\r<br>\r<br> 2. Impossibility to complete a PET scan: pregnancy, nuclear medicine irradiation for\r<br> clinical research in the year preceding baseline visit.\r<br>\r<br> 3. Contraindication to auxiliary medicinal products ([18F]-florbetaben)\r<br>\r<br> 4. Known presence of any neurological disorders\r<br>\r<br> 5. Pregnancy and/or lactation\r<br>\r<br> 6. Lack of peripheral venous access\r<br>\r<br> 7. Terminal renal insufficiency (Creatinin clearance < 60 ml/min)\r<br>\r<br> 8. Legal protection (curatorship or tutorship)\r<br>\r<br> 9. Deprive of freedom or under security measure\r<br>\r<br> 10. Participation in another interventional trial evaluating a health product or any\r<br> randomized trial or being in the exclusion period at the end of a previous study\r<br>\r<br> 11. Refusal to be informed in case of clinically significant incidental discovery after\r<br> MRI\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis;Remitting Relapsing Multiple Sclerosis", "intervention": "Drug: Ifenprodil;Drug: Placebo", "primary_outcome": "Change in P100 latency according to visual evoked potential.", "secondary_outcome": "Proportion of voxels within white matter lesions classified as remyelinating;Proportion of remyelinating voxels extracted in cortical regions from magnetization transfer imaging (MTR) acquisitions;Change in amplitude of P100 on to visual evoked potential;Change in retinal nerve fibre layer (RNFL) and ganglion cell complex (GCC) thickness on OCT;Change in blood concentration of NfL fragments;Change in the brain atrophy rate;The correlation between the change in the proportion of remyelinating voxels extracted in white matter lesions from [18F]florbetaben PET acquisitions;The comparison of the proportion of remyelinating voxels extracted in white matter lesions from [18F]florbetaben PET acquisitions;Incidence of adverse drug reactions", "secondary_id": "2021-003584-99;APHP200027", "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": 4323, "title": "Self-compassion for People With Multiple Sclerosis: An Exploratory Feasibility Study", "summary": "<b>Conditions</b>: Multiple Sclerosis; Self-Compassion\n<br /><b>Interventions</b>: Behavioral: Self-compassion intervention (the Mindful Self-Compassion course)\n<br /><b>Sponsors</b>: Robert Simpson\n<br /><b>Not yet recruiting</b>", "published_date": "2024-03-19T00:00:00Z", "discovery_date": "2024-04-08T17:13:41.446922Z", "link": "https://clinicaltrials.gov/ct2/show/NCT06337903", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT06337903", "euct": null, "eudract": null }, "categories": [], "export_date": "2024-05-04T00:00:00Z", "internal_number": "13879483", "last_refreshed_on": "2024-04-08", "scientific_title": "Self-compassion for People With Multiple Sclerosis: An Exploratory Feasibility Study", "primary_sponsor": "Robert Simpson", "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": "2024-05-01", "target_size": "45", "study_type": "Interventional", "study_design": "Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Health Services Research. Masking: None (Open Label).", "phase": "N/A", "countries": "Canada", "contact_firstname": "; ;", "contact_lastname": "Robert Simpson, PhD;Robert Simpson, PhD;Robert Simpson, PhD", "contact_address": null, "contact_email": ";[email protected];", "contact_tel": ";416-360-4000;", "contact_affiliation": "Unity Health Toronto;", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> 1. Aged 18 years or older\r<br>\r<br> 2. Able to understand spoken and written English\r<br>\r<br> 3. Have a neurologist-confirmed diagnosis of multiple sclerosis\r<br>\r<br> 4. Willing to take place in an Mindful Self Compassion course\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> 1. Cognitive impairment (<26 on the Montreal Cognitive Assessment)\r<br>\r<br> 2. Severe active mental health impairment (psychosis, suicidality)\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis;Self-Compassion", "intervention": "Behavioral: Self-compassion intervention (the Mindful Self-Compassion course)", "primary_outcome": "Recruitment;Retention;Adherence;Follow-up rates", "secondary_outcome": "Stress;Anxiety;Depression;Self-compassion;Emotion Regulation;Quality of Life using the Multiple Sclerosis Impact Scale (MSIS-29);Participant Experiences and Perspectives;Adjustment", "secondary_id": "Self-compassion for PwMS", "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 } ] }