[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"rrms\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:rrms":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,58,91],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":57},"100632201","phase-2-hyperpolarized-carbon-metabolic-imaging-in-multiple-sclerosis-100632201",false,"NCT07510607","Hyperpolarized Carbon Metabolic Imaging in Multiple Sclerosis","Assessing Metabolic Changes in Multiple Sclerosis Using Hyper-polarized Carbon 13 MRI","MIIMS","Inclusion criteria:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Subjects must be 18 years or older.\n2. Relapsing remitting MS, naïve to DMTs for the past two years minimum\n3. Patients must be naive to anti-CD20 therapy with plans to begin the therapy as part of their physician's multiple sclerosis treatment plan. The patients must remain on a form of anti-CD20 therapy for the entirety of their enrollment in the study.\n4. Patients enrolled will be screened for at least one MS lesion with a 10mm diameter in one plane.\n\nExclusion criteria:\n\n1. Treatment with corticosteroids within 30 days prior to screening.\n2. Patients unwilling or unable to undergo MR imaging, including patients with contra-indications to MRI, such as cardiac pacemakers or non-compatible intracranial vascular clips.\n3. Poorly controlled hypertension, defined as either systolic \\>160 or diastolic \\>110. The addition of anti-hypertensives to control blood pressure is allowed for eligibility determination.\n4. Congestive Heart Failure ≥ NYHA Class II.\n5. History of clinically significant EKG abnormalities, including QT prolongation or a family history of prolonged QT syndrome.\n6. Myocardial infarction within 6 months of study entry.\n7. Individuals who are pregnant. Individuals of childbearing potential (defined below) must agree to undergo a urine pregnancy test prior to participating in the study scans. Pregnant individuals are excluded because there is an unknown but potential risk for adverse effects in the unborn child secondary to administration of HP 13C pyruvate to the study participant.\n\n   A female is considered to not be of childbearing potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice), if they meet either of the following two criteria: (1) has reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause); or (2) has undergone surgical sterilization (i.e., hysterectomy and\u002For bilateral oophorectomy for removal of uterus and\u002For ovaries).\n8. Individuals who are breastfeeding\u002Fchestfeeding. Breastfeeding\u002Fchestfeeding individuals are excluded because there is an unknown but potential risk for adverse effects in the unborn\u002Fnursing child secondary to administration of HP 13C pyruvate to the study participant.\n\n   Breastfeeding\u002Fchestfeeding should be discontinued before administration of HP 13C pyruvate.\n9. Known hypersensitivity to HP 13C pyruvate or any of its excipients.\n10. History of cancer within five years of enrollment date and\u002For history of chemotherapy within two years of enrollment date.\n11. Any dental braces or permanent or undetachable metals in the jaw or face.\n12. 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.\n13. Individuals with any condition or social circumstance that, in the opinion of the investigator, would impair the participant's ability to comply with study procedures.\n14. Glomerular filtration rate (GFR) of less than 60 mL\u002Fmin\u002F1.73 m² on baseline visit or subsequent study visits, history of kidney disease or history of hypersensitivity to gadolinium contrast agent.\n15. Baseline EDSS \\>6.5",true,"ALL","18 Years",{"count":21,"type":22},40,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","The main purpose of this study is to assess whether hyperpolarized carbon imaging in relapsing remitting multiple sclerosis (MS) patients can be used to predict response to anti-CD20 disease modifying therapy. Study procedures will include magnetic resonance imaging (MRI) assessments with a hyperpolarized pyruvate sequence, clinical assessment as well as blood markers of disease progression.\n\nThis method of imaging utilizes the Warburg effect, where innate immune cells utilize a metabolic shift to glycolysis instead of oxidative phosphorylation. In pre-clinical data, increased hyperpolarized lactate production has been found to be associated with increased microglial\u002Fmacrophage infiltration in the brain. Although hyperpolarized carbon imaging in humans has been established and used in the field of oncology, this will be one of the first applications of hyperpolarized carbon the study of neuroinflammation in humans. We predict that hyperpolarized carbon imaging may have the potential to monitor and evaluate neuroinflammation in MS, and in particular the innate immune activation state that plays a role in MS progression. This imaging method may provide non-invasive monitoring of disease progression and therapy response for MS patients.",[28,29,30],"Multiple Sclerosis","RRMS","Relapsing Remitting MS",[32,28,33,34,29,35,36,37,38,39,40,41,30,42,43,44,45],"Hyperpolarized Carbon","Anti-CD20","Ocrevus","MS","Metabolic Imaging","Hyperpolarized Pyruvate","MRI","Magnetic Resonance Imaging","UCSF","Ari Green","ocrelizumab","Jeremy Gordon","MS biomarker","MS prognosis","RECRUITING","2026-06-04",{"date":49,"type":50},"2026-06-08","ACTUAL",{"date":52,"type":50},"2026-06-03",{"date":54,"type":22},"2029-12-01",{"name":41,"class":56},"OTHER",1,{"id":59,"slug":60,"hasResults":11,"nctId":61,"briefTitle":62,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":65,"enrollmentInfo":66,"targetDuration":4,"studyType":23,"phases":68,"briefSummary":70,"conditions":71,"keywords":73,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":90},"100634915","multicenter-prospective-study-analyzing-the-occurrence-of-multiple-sclerosis-relapses-without-radiological-evidence-myth-or-reality-100634915","NCT07545889","Multicenter Prospective Study Analyzing the Occurrence of Multiple Sclerosis Relapses Without Radiological Evidence: Myth or Reality?","MYTH-MS","Inclusion Criteria:\n\n* Adult aged 18 to 70 years.\n* Relapsing-Remitting Multiple Sclerosis according to the McDonald 2024 criteria.\n* Patient receiving disease-modifying therapy (DMT) for multiple sclerosis.\n* Most recent EDSS score between 0 and 7.0, dating back less than 1 year.\n* Patient presenting with a neurological exacerbation lasting more than 24 hours and less than 7 days (excluding fatigue and pain alone).\n* Patient capable of understanding the objectives and risks associated with the study and who has provided informed consent.\n* Patient affiliated with or a beneficiary of a social security health insurance scheme.\n\nExclusion Criteria:\n\n* Primary progressive or secondary progressive multiple sclerosis.\n* Diagnosis of chronic psychotic disorder.\n* Infection within the past week.\n* Body temperature \\> 38.5°C at V0 (baseline visit).\n* Corticosteroid bolus or plasma exchange in the month preceding inclusion.\n* Chronic treatment with corticosteroids or immunosuppressants for another pathology.\n* Contraindication to MRI or gadolinium.\n* Uncontrolled cardiac, renal, or hepatic pathology.\n* Patient participating in another interventional study or still within an exclusion period.\n* Pregnant or breastfeeding woman.\n* Severe claustrophobia.\n* Patient deprived of liberty (e.g., incarcerated).","70 Years",{"count":67,"type":22},136,[69],"NA","The MYTH-MS study is a multicenter prospective study investigating the occurrence of clinical relapses in patients with relapsing-remitting multiple sclerosis (RRMS) in the absence of radiological activity on MRI.\n\nWhile MS relapses are typically associated with gadolinium-enhancing lesions on MRI, some patients present with acute neurological symptoms without radiological correlates, referred to as acute clinical events with stable MRI (ACES). The frequency, mechanisms, and clinical relevance of these events remain unclear due to limitations in previous studies.\n\nThe primary objective is to determine the proportion of RRMS patients experiencing a relapse without gadolinium-enhancing lesions on early brain and spinal MRI. Secondary objectives include identifying clinical, radiological, biological, and psychological predictors, assessing neurologists' diagnostic accuracy, and evaluating clinical outcomes such as disability, cognition, and quality of life over a 6-month follow-up.\n\nA total of 136 patients with recent neurological exacerbations will be included. Each participant will undergo clinical assessment, cognitive and psychological evaluation, and early MRI, with follow-up at 6 months. An ancillary study will explore blood biomarkers (NfL, GFAP, and circulating DNA) to help differentiate true inflammatory relapses from ACES.\n\nThis study aims to improve the understanding and diagnosis of MS exacerbations and to optimize patient management by reducing misdiagnosis and unnecessary treatments.",[28,29,72],"Multiple Sclerosis (MS) - Relapsing-remitting",[28,74,75,76,77,78,79],"Relapsing-Remitting Multiple Sclerosis","Acute Clinical Events with Stable MRI (ACES)","Gadolinium-enhancing lesions","MRI-negative relapse","Functional Neurological Disorder","Pseudo-relapse","NOT_YET_RECRUITING","2026-04-15",{"date":83,"type":50},"2026-04-22",{"date":85,"type":22},"2026-09-01",{"date":87,"type":22},"2030-05-01",{"name":89,"class":56},"University Hospital, Strasbourg, France",8,{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":4,"eligibilityCriteria":97,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":98,"targetDuration":4,"studyType":100,"phases":4,"briefSummary":101,"conditions":102,"keywords":4,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":4},"100595851","effectiveness-of-the-combination-strategy-of-disease-modifying-therapy-and-the-yishen-daluo-yin-modified-formula-for-multiple-sclerosis-100595851","NCT07037823","Effectiveness of the Combination Strategy of Disease-Modifying Therapy and the Yishen Daluo Yin Modified Formula for Multiple Sclerosis","Effectiveness of the Combination Strategy of Disease-Modifying Therapy and the Yishen Daluo Yin Modified Formula for Multiple Sclerosis: A Prospective Multi-Center Observational Comparative Study","Inclusion Criteria:\n\n1. Participants who are over 18 years old at the time of signing the informed consent form, with no gender restrictions.\n2. Participants meet the diagnostic criteria for multiple sclerosis (MS) as outlined in the 2017 McDonald's diagnostic criteria and the 2023 edition of the Chinese Guidelines for the Diagnosis and Treatment of Multiple Sclerosis.\n3. No clinical relapse, as defined in the protocol, has occurred for 30 days or more prior to screening and baseline (Day 1).\n4. Patients receiving first-line DMT drug treatment at a stable dosage. (The first-line DMT drugs involved in this study have stable dosages: Teriflunomide (14 mg, oral, once daily), Dimethyl Fumarate (240 mg, oral, twice daily), Fingolimod Hydrochloride (0.5 mg, oral, once daily), Siponimod (1 mg or 2 mg daily), Ozanimod (0.92 mg, oral, once daily), Ofatumumab (20 mg, subcutaneous injection once every 28 days), and Glatiramer Acetate (20 mg, subcutaneous injection once daily or 40 mg, three times a week).)\n5. Signing the informed consent form.\n6. Participants were able to engage in clinical follow-up throughout the entire study period.\n\nExclusion Criteria:\n\n1. According to the 2017 McDonald's guidelines and the 2023 version of the Chinese Multiple Sclerosis Diagnosis and Treatment Guidelines, individuals diagnosed with progressive MS, including both primary progressive MS (PPMS) and secondary progressive MS (SPMS), are excluded.\n2. Participants who cannot performe MRI scans in certain situations include individuals with known allergic reactions to gadolinium contrast agents or those with other contraindications.\n3. The expected lifespan is less than one year.\n4. Participants who cannot complet the study due to mental illness, cognitive or emotional disorders.\n5. Pregnant or lactating women.\n6. Patients who are currently receiving or participating in other immunosuppressive, immunomodulatory, MS DMT treatment or clinical trials.\n7. Any situation that other researchers deem inappropriate for participation in this study.",{"count":99,"type":22},328,"OBSERVATIONAL","This study was designed to investigate the effectiveness of a combined strategy utilizing disease-modifying therapy and the modified Yishen Daluo Yin formula for relapsing-remitting multiple sclerosis (RRMS) through a prospective, multicenter, observational comparative study.",[29],"2025-06-17",{"date":105,"type":50},"2025-06-26",{"date":107,"type":22},"2025-07-01",{"date":109,"type":22},"2026-12-31",{"name":111,"class":56},"Ying Gao"]