[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"demyelinating-diseases\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:demyelinating-diseases":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,53,107,129],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":34,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100521136","phase-1-assessing-changes-in-multi-parametric-mri-in-patients-with-acute-demyelinating-lesions-taking-clemastine-fumarate-as-a-myelin-repair-therapy-100521136",false,"NCT06065670","Assessing Changes in Multi-parametric MRI in Patients With Acute Demyelinating Lesions Taking Clemastine Fumarate as a Myelin Repair Therapy","A Randomized, Double-Blind, Delayed Treatment, Placebo-Controlled Trial to Assess the Changes in Multi-parametric MRI in Patients With Acute Demyelinating Lesions Taking Clemastine Fumarate as a Myelin Repair Therapy","ReINFORCE","Inclusion Criteria:\n\n* Written informed consent must be obtained prior to any assessment being performed.\n* Patients diagnosed with relapsing remitting multiple sclerosis and a disease duration of \\\u003C 15 years\n* Male or female patients aged 18-55 years (inclusive)\n* Use of appropriate contraception during period of trial (women). Before entry women must be:\n\n  * Post-menopausal for at least 1 year OR\n  * Surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, male partner vasectomy or otherwise incapable of pregnancy) OR\n  * Practicing a highly effective method of birth control if sexually active, including hormonal prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double barrier method (e.g., condoms, diaphragm or cervical cap with spermicidal foam, cream or gel), or male partner sterilization consistent with local regulations regarding use of birth control methods for patients participating in clinical trials, for the duration of their participation in the study OR\n  * Not heterosexually active (patients who are not heterosexually active at screening must agree to utilize a highly effective method of birth control if they become heterosexually active during their participation in the study) OR\n  * Practicing true abstinence (when this is in line with the preferred and usual lifestyle of the subject) Period abstinence (e.g., calendar, ovulation, symptothermal, post ovulation methods) is not an acceptable method.\n\nExclusion Criteria:\n\n* Radiologic identification of marked brain atrophy relative to patients age based on recent MRI and interpretation of expert neuroradiologist or PI\n* New lesion in most recent MRI (within 3 months)\n* Hypersensitivity to clemastine or other arylalkylamine antihistamines, or any of the excipients.\n* Treatment with corticosteroids within 30 days prior to screening.\n* Expanded Disability Status Scale (EDSS) ≥ 4.5\n* History of significant cardiac conduction block.\n* History of cancer.\n* Suicidal ideation or behavior in 6 months prior to baseline.\n* Pregnancy, breastfeeding or planning to become pregnant.\n* Involved with other study protocols simultaneously without prior approval.\n* Concomitant use of any other putative remyelinating therapy as determined by the investigator.\n* Prior treatment with total lymphoid irradiation, T cell or T cell receptor vaccination.\n* Prior treatment with alemtuzumab, mitoxantrone, or cyclophosphamide.\n* Serum creatinine \\> 1.5 mg\u002FdL; aspartate transaminase (AST), alanine transaminase (ALT), or alkaline phosphatase \\> 2 times the upper limit of normal. (Reported within 72 hours)\n* History of drug or alcohol abuse within the past year.\n* Untreated B12 deficiency (as determined by B12 serological assessments and metabolites including methylmalonic acid \\[MMA\\] and homocysteine) or untreated hypothyroidism.\n* Clinically significant cardiac, metabolic, hematologic, hepatic, immunologic, urologic, endocrinologic, neurologic, pulmonary, psychiatric, dermatologic, allergic, renal, or other major diseases that in the PI's judgment may affect the interpretation of study results or patient safety.\n* History of or presence of clinically significant medical illness or laboratory abnormality that, in the opinion of the investigator would preclude participation in the study\n* Inability to participate in MRI, including extreme claustrophobia.\n* Any dental braces or permanent or undetachable metals in the jaw or face.","ALL","18 Years","55 Years",{"count":21,"type":22},44,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","The clinical trial is intended to assess for clinical evidence of Clemastine Fumarate as a myelin repair therapy in patients with acute inflammatory injury-causing demyelination as measured by multi-parametric MRI assessments.\n\nNo reparative therapies exist for the treatment of acute demyelinating lesions. Clemastine fumarate was identified along with a series of other antimuscarinic medications as a potential remyelinating agent using the micropillar screen (BIMA) developed at the University of California, San Francisco (UCSF). Following in vivo validation, an FDA IND exemption was granted to investigate clemastine for the treatment of multiple sclerosis in the context of chronic optic neuropathy. That pilot study was recently completed and is the first randomized control trial documenting efficacy for a putative remyelinating agent for the treatment of MS. The preselected primary efficacy endpoint (visual evoked potential) was met and a strong trend to benefit was seen for the principal secondary endpoint assessing function (low contrast visual acuity). That trial number was 13-11577.\n\nThis study seeks to follow up on that study and examine clemastine fumarate's protective and reparative effects in the context of acute demyelinating brain lesions as imaged by multi-parametric MRI assessments. The investigators will be assessing the effects of clemastine fumarate as a remyelinating therapy and assessing its effect on MRI metrics of lesions found in patients with a confirmed diagnosis of acute inflammatory injury-causing demyelination.\n\nIn addition to using conventional multi-parametric MRI assessments, this study will also evaluate a new MRI technique called Ultrashort Echo Time (UTE) MRI to assess the effects of clemastine fumarate as a remyelinating therapy of acute lesions found in patients with a confirmed diagnosis of acute inflammatory injury-causing demyelination and compare it to the other assessments.",[29,30,31,32,33],"Demyelinating Diseases","Demyelination; Corpus Callosum","Multiple Sclerosis Brain Lesion","Multiple Sclerosis Acute and Progressive","Clinically Isolated Syndrome, CNS Demyelinating",[35,36,37,38,39],"acute brain lesions","mri","brain","demyelinating lesions","spinal cord","NOT_YET_RECRUITING","2026-03-09",{"date":43,"type":44},"2026-03-11","ACTUAL",{"date":46,"type":22},"2026-09-15",{"date":48,"type":22},"2028-10-30",{"name":50,"class":51},"University of California, San Francisco","OTHER",1,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":4,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":60,"targetDuration":62,"studyType":63,"phases":4,"briefSummary":64,"conditions":65,"keywords":91,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":52},"100560175","institutional-registry-of-rare-diseases-100560175","NCT06573723","Institutional Registry of Rare Diseases","Institutional Registries of Rare Diseases at Hospital Italiano de Buenos Aires (HIBA)","Inclusion Criteria:\n\n* Clinical and\u002For molecular diagnosis of any of the following rare diseases: Amyloidosis, Sarcoidosis, Phacomatosis, Pheochromocytoma, Paraganglioma, Von Hippel-Lindau Disease, Immunoglobulin G4-Related Disease, Demyelinating Diseases, Inborn Errors of Metabolism, Eosinophilic Gastrointestinal Disorders, Hypertrophic Cardiomyopathy, Gaucher Disease, Congenital Adrenal Hyperplasia, Hereditary Angioedema, Pulmonary Hypertension, Wilson Disease, Vascular Anomalies, Mastocytosis, Multiple Endocrine Neoplasia, Inflammatory Bowel Diseases, Prader-Willi Syndrome, Hirschsprung Disease, or Cushing Syndrome.\n* Must be followed at Hospital Italiano de Buenos Aires.\n\nExclusion Criteria:\n\n\\- Refusal to participate in the study or in the informed consent process.",{"count":61,"type":22},380,"10 Years","OBSERVATIONAL","The goal of this observational study is to create a single macro registry system with data collection on common clinical features, grouping the different rare diseases (RD).\n\nMoreover, the specific goals are to generate an alert system for possible cases of RD with data from the electronic medical record, to describe the occurrence of RD in the evaluated population, to characterize the population, to describe patterns of diagnosis and treatment of RD present at the time, and to explore patient-reported outcomes.",[66,67,68,69,70,71,72,73,29,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90],"Rare Diseases","Amyloidosis","Sarcoidosis","Phacomatosis","Pheochromocytoma","Paraganglioma","Von Hippel-Lindau Disease","Immunoglobulin G4-Related Disease","Inborn Errors of Metabolism","Eosinophilic Gastrointestinal Disorders","Hypertrophic Cardiomyopathy","Gaucher Disease","Congenital Adrenal Hyperplasia","Hereditary Angioedema","Pulmonary Hypertension","Wilson Disease","Vascular Anomalies","Mastocytosis","Multiple Endocrine Neoplasia","Inflammatory Bowel Diseases","Prader-Willi Syndrome","Hirschsprung Disease","Cushing Syndrome","HHT","Hemorrhagic Hereditary Telangiectasia",[92,93,94,69,95,96,72,73,29,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,90],"rare diseases","amyloidosis","sarcoidosis","pheochromocytoma","paraganglioma","RECRUITING","2026-01-12",{"date":100,"type":44},"2026-01-14",{"date":102,"type":44},"2024-07-01",{"date":104,"type":22},"2034-12-31",{"name":106,"class":51},"Hospital Italiano de Buenos Aires",{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":63,"phases":4,"briefSummary":116,"conditions":117,"keywords":119,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":52},"100554064","comparison-of-diagnostic-performances-of-3d-flair-dir-and-psir-sequences-in-optic-neuritis-100554064","NCT06494228","Comparison of Diagnostic Performances of 3D FLAIR, DIR and PSIR Sequences in Optic Neuritis","Optic-Neuritis","Inclusion Criteria:\n\n* Major subject (≥18 years old)\n* Subject suffering from multiple sclerosis or an NMO spectrum disease\n* Subject having received an MRI including 3D FLAIR, 3D DIR and 3D PSIR sequences\n* Brain MRIs of eligible subjects acquired between April 1, 2019 and November 30, 2021.\n* No opposition to the reuse of its data for scientific research purposes.\n\nExclusion Criteria:\n\n* Presence of opposition from the subject (and\u002For their legal representative if applicable) to the reuse of their data for scientific research purposes.\n* Artifacts not allowing satisfactory interpretation",{"count":115,"type":22},60,"Ultimately improve the care of patients suffering from multiple sclerosis (1st cause of acquired non-traumatic disability in adults) and NMO spectrum diseases by using more efficient MRI sequences than the FLAIR sequence commonly used in detection of optic neuritis.\n\nIn the literature, many studies have already focused on comparing the sensitivity of detection of white matter demyelination plaques using FLAIR, PSIR or DIR sequences.\n\nSome authors have shown better sensitivity of the PSIR sequence in the detection of demyelinating lesions of the marrow in multiple sclerosis compared to conventional sequences.\n\nOthers have shown better performance of the combined use of PSIR and DIR sequences compared to the FLAIR sequence in the detection of cortical lesions in multiple sclerosis.\n\nHowever, in the context of optic neuritis, few comparative studies comparing these three sequences have been carried out:\n\nA 2022 study showed better diagnostic sensitivity of optic neuritis of the DIR sequence compared to the FLAIR sequence.\n\nA possible better diagnostic performance of a sequence not used in current practice in the detection of optic neuritis (PSIR and DIR sequences), would be possible to justify their use on a larger scale and ultimately improve patient care.",[118,29],"Multiple Sclerosis",[118,29],"2024-07-02",{"date":122,"type":44},"2024-07-10",{"date":124,"type":44},"2024-01-19",{"date":126,"type":22},"2025-01-19",{"name":128,"class":51},"University Hospital, Strasbourg, France",{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":135,"eligibilityCriteria":136,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":137,"targetDuration":4,"studyType":23,"phases":139,"briefSummary":141,"conditions":142,"keywords":147,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":52},"100503407","phase-3-non-inferiority-study-of-rituximab-compared-to-ocrelizumab-in-relapsing-ms-100503407","NCT05834855","Non-inferiority Study of Rituximab Compared to Ocrelizumab in Relapsing MS","Non-inferiority Study of Rituximab Compared to Ocrelizumab in Relapsing Multiple Sclerosis","Noisy Rebels","Inclusion Criteria:\n\n1. Men and women aged 18 years and older\n2. A diagnosis of relapsing MS according to the 2017 revised diagnostic criteria\n3. Indication to start treatment with anti-CD20 therapy according to the treating neurologist and the relevant label in the Netherlands for treatment of relapsing MS\n4. Able to understand written and spoken Dutch or English\n5. Capable of giving signed informed consent including compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n6. Screening EDSS score ≤ 6.5 .\n\nExclusion Criteria:\n\nMedical Conditions\n\n1. A known allergy or other intolerability to RTX, OCR, gadolinium-based MRI contrast agents, or corticosteroids.\n2. A diagnosis of primary progressive MS according to the diagnostic criteria.\n3. A diagnosis of not-active secondary progressive MS.\n4. Chronic infectious diseases such as tuberculosis, VZV, hepatitis virus or HIV, as well as hepatitis B surface antigen positivity and\u002For hepatitis C PCR positivity verified at screening visit.\n5. A history of proven inflammatory bowel disease such as M. Crohn or ulcerative colitis\n6. Prior or current psychiatric illness, mental deficiency or cognitive dysfunction influencing the patient ability to make an informed consent or comply with the treatment and follow-up phases of this protocol.\n7. Cardiac disease that makes treatment with OCR or RTX contra-indicated as stated by the most recent SmPC\n8. Active malignancy or prior history of malignancy that makes treatment with OCR or RTX contra-indicated as stated by the most recent SmPC.\n9. WBC \\\u003C 1.5 x 109\u002FL if not caused by a reversible effect of documented ongoing medication. If caused by a reversible effect of documented ongoing medication the WBC count must be \\> 1,5 x 109\u002FL before start of study treatment.\n10. Platelet (thrombocyte) count \\\u003C 100 x 109\u002FL\n11. ALAT and\u002For ASAT more than 2 times the upper normal reference limit (ULN)\n12. Serum creatinine \\> 200 μmol\u002FL\n13. Serum bilirubin \\> ULN\n14. Serum IgG \\\u003C LLN\n15. Pregnant or breast-feeding women\n16. Women of childbearing potential (WOCBP) not able or willing to use highly effective methods of birth control per ICH M3 (R2) that result in failure rate of ≤ 1% per year when used consistently and correctly for the duration of the study OR until 3 months after last dose administered.\n17. History of serious or life-threatening infusion reaction to OCR or RTX\n18. Treatment with glucocorticoids or ACTH within one month prior to start of study treatment\n\n    Prior\u002FConcomitant Therapy\n19. Previous use of second line MS-therapies cladribine, RTX, alemtuzumab, OCR, ofatumumab, hematopoietic stem cell therapy (HSCT) or other immunosuppression therapies with long lasting effects. Mitoxantrone is allowed if used \\> 1 year before enrolment. If any of these medications have been used for indications other than MS, patients can be included if the medications have not been used the year before enrolment. Previous treatment with natalizumab is allowed if the reason to switch was disease activity (so not allowed in for example cases that switch from natalizumab to anti-CD20 therapy because of JCV positivity).\n20. Concomitant use of systemic immunosuppressive medication (except corticosteroids for symptomatic treatment of relapses).\n\n    Prior\u002FConcurrent Clinical Study Experience\n21. Currently enrolled in another investigational device or drug study, or less than 30 days since ending of another investigational device or drug study (s), or receiving other investigational treatment(s). Patients participating in a purely observational studies will be allowed to participate.\n\n    Lifestyle\n22. Current alcohol or drug dependencies.\n\n    Diagnostic assessments\n23. Presence of metallic objects implanted in the body, that would preclude the ability of the patient to safely have MRI exams.\n24. Not willing to undergo MRI scans with i.v. gadolinium injections",{"count":138,"type":22},200,[140],"PHASE3","Rationale: Ocrelizumab is widely and effectively used to treat relapsing multiple sclerosis (RMS). Phase II studies and data from large patient cohorts indicate that rituximab, another anti-CD20 monoclonal antibody, is probably equally effective and safe as ocrelizumab in the treatment of RMS. An advantage of rituximab is a considerably lower price. Therefore we will start a study aimed at demonstrating non-inferiority of rituximab compared to ocrelizumab in RMS. If non-inferiority of rituximab can be shown, important reductions in the cost of treatment of RMS will be possible, without loss of efficacy.\n\nObjective: Evaluating the efficacy and safety of ritixumab compared to ocrelizumab in the treatmens of RMS.\n\nStudy design: Randomized double blind multi-centre non-inferiority study of rituximab compared to ocrelizumab in 200 patients with RMS. The trial duration will be 30 months\n\nStudy population: The study population consists of 200 adult RMS patiens with an indication to start anti-CD20 monoclonal antibody treatment.\n\nIntervention: Patients will be randomized 1:1 into the standard group (ocrelizumab treatment) or the experimental group (rituximab treatment).\n\nMain study parameters: To conclude non-inferiority of rituximab there will be one primary endpoint: the proportion of patients free of inflammatory disease activity (defined as: new or enlarged T2 lesions) between week 24 (M6) and week 96 (M24) of treatment in each arm. Secondary trial endpoints are presence and number of clinical relapses,T2 and contrast enhancing lesion volumes, brain volume and brain volume changes, disease progression (defined as clinically relevant change on any of the measures: EDSS, T25FW, 9HPT, SDMT), biochemical parameters such as lipidomics and neurofilament light (NfL), immunological parameters, safety as measured by the number of (serious) adverse events ((S)AE), quality of life (EQ-5D-L) and treatment satisfaction (TSQM) and patient reported measures of MS impact (MSIS-29) and well-being (questionnaire on physical complaints)\n\nNature and extent of the burden and risk: Patients included in this study will be treated and monitored by MRI, clinical tests and laboratory tests according to existing protocols and will not be exposed to extra or unknown risks. They will have extra annual questionnaires and larger blood samples at some time points. There is extensive experience with both rituximab and ocrelizumab as efficacious and safe treatments of RMS.",[118,143,144,145,146,29],"Multiple Sclerosis, Relapsing-Remitting","Demyelinating Autoimmune Diseases, CNS","Autoimmune Diseases of the Nervous System","Nervous System Diseases",[148,149,150],"ocrelizumab","rituximab","non-inferiority","2023-04-17",{"date":153,"type":44},"2023-04-28",{"date":155,"type":22},"2023-04",{"date":157,"type":22},"2027-05",{"name":159,"class":51},"Amsterdam UMC, location VUmc"]