A Study to Evaluate the Safety, Tolerability, Efficacy, and Drug Levels of CC-97540 in Participants With Relapsing Forms of Multiple Sclerosis, Progressive Forms of Multiple Sclerosis or Refractory Myasthenia Gravis (MG) (Breakfree-2)
NCT06220201 ·
Multiple Sclerosis, Myasthenia Gravis
RecruitingThe purpose of this study is to evaluate the safety, tolerability, efficacy, and drug levels of CC-97540 in participants with Relapsing Forms of Multiple Sclerosis (RMS), Progressive Forms of Multiple Sclerosis (PMS) or Refractory Myasthenia Gravis (MG).
PhasePhase 1
TypeInterventional
Age18 Years – 60 Years
WhereBirmingham, Alabama, United States + 34 more
SponsorJuno Therapeutics, Inc., a Bristol-Myers Squibb Company
▾Tap for detailsClick for full details — eligibility, all locations, contacts RE104 Safety and Efficacy Study in Adjustment Disorder in Cancer and Other Medical Illnesses
NCT07002034 · Adjustment Disorder
RecruitingThe purpose of this study is to determine if treatment with a single dose of RE104 for Injection reduces depressive symptoms or depressive symptoms mixed with anxiety symptoms in participants with Adjustment Disorder due to cancer or other illnesses such as Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), Parkinson's Disease (PD) or Idiopathic Pulmonary Fibrosis (IPF) as compared to active-placebo.
PhasePhase 2
TypeInterventional
Age18 Years – 80 Years
WhereBirmingham, Alabama, United States + 29 more
SponsorReunion Neuroscience Inc
▾Tap for detailsClick for full details — eligibility, all locations, contacts Stopping TSC Onset and Progression 2B: Sirolimus TSC Epilepsy Prevention Study
NCT05104983 · Tuberous Sclerosis Complex, Epilepsy
RecruitingThis trial is a Phase II randomized, double-blind, placebo controlled multi-site study to evaluate the safety and efficacy of early sirolimus to prevent or delay seizure onset in TSC infants. This study is supported by research funding from the Office of Orphan Products Division (OOPD) of the US Food and Drug Administration (FDA).
PhasePhase 2
TypeInterventional
Age1 Day – 6 Months
WhereBirmingham, Alabama, United States + 10 more
SponsorDarcy Krueger
▾Tap for detailsClick for full details — eligibility, all locations, contacts An Open-label Study of AZD0120 in Adults With Multiple Sclerosis
RecruitingThis trial is a Phase 1b, open-label, multi-center, clinical study of AZD0120, a BCMA/CD19 dual targeting CAR+ T-cell therapy, to evaluate the safety and tolerability in adult participants with Multiple Sclerosis.
PhasePhase 1
TypeInterventional
Age18 Years – 60 Years
WhereTucson, Arizona, United States + 18 more
SponsorAstraZeneca
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study Evaluating the Safety and Efficacy of KITE-363 in Relapsed/Refractory Autoimmune Neurologic Diseases
NCT07304154 · Chronic Inflammatory Demyelinating Polyneuropathy, Myasthenia Gravis,
Multiple Sclerosis RecruitingThis study will have two Phases: Phase 1a and Phase 1b. The goals of this clinical study are to learn more about the study drug KITE-363, by evaluating its safety, tolerability and efficacy in participants with relapsed/refractory autoimmune neurologic diseases. The primary objectives of this study are: * To evaluate the safety and tolerability of KITE-363 in participants with autoimmune neurologic diseases * To determine the recommended dose for Phase 1b. * To evaluate the preliminary efficacy of KITE-363 in participants with autoimmune neurologic diseases.
PhasePhase 1
TypeInterventional
Age18 Years – 75 Years
WhereSalt Lake City, Utah, United States + 2 more
SponsorKite, A Gilead Company
▾Tap for detailsClick for full details — eligibility, all locations, contacts Non-invasive Electrical Spinal Cord Stimulation To Restore Upper Extremity Function in Multiple Sclerosis
RecruitingCurrent disease-modifying therapies for multiple sclerosis (MS) aim to prevent the development of new lesions; unfortunately, no current FDA-approved therapies promote central nervous system (CNS) repair mechanisms. Thus, strategies to promote functional recovery from lesion-related deficits in adults with MS remain an unmet need. This is a pilot study designed to test the feasibility, safety and preliminary efficacy of non-invasive (transcutaneous, applied by surface electrodes over the skin) electrical spinal cord stimulation combined with occupational therapy for restoring upper extremity sensorimotor function in adults with multiple sclerosis. Participants with multiple sclerosis and impaired upper extremity function will complete two separate 6-week intervention sessions: 6 weeks of occupational therapy combined with transcutaneous spinal cord stimulation and 6 weeks of occupational therapy alone. The order of these interventions will be randomized, and each intervention will be separated by a 6-week washout period. The investigators hypothesize that: 1. transcutaneous spinal cord stimulation combined with therapy will be feasible and acceptable by participants 2. transcutaneous spinal cord stimulation combined with therapy will lead to improvements in upper extremity function compared to occupational therapy alone 3. transcutaneous spinal cord stimulation combined with therapy will lead to improvements in symptoms related to quality of life (pain, spasticity, and bladder symptoms) compared to occupational therapy alone
PhasePhase 1
TypeInterventional
Age21 Years – 70 Years
WhereSeattle, Washington, United States
SponsorUniversity of Washington
▾Tap for detailsClick for full details — eligibility, all locations, contacts The SetPoint System as a Pro-Remyelination Therapy for Relapsing-Remitting Multiple Sclerosis: A Pilot Study
RecruitingThe MS pilot study will assess the safety and investigate the remyelinating effects of the SetPoint System (study device) in adult patients with patients diagnosed with relapsing-remitting multiple sclerosis (RRMS). The SetPoint System is intended for adjunctive use with standard of care therapy for RRMS. The study device contains a miniaturized stimulator (implant) that is surgically placed under general anesthesia on the vagus nerve through a small incision on the left side of the neck (implant procedure). The study will enroll up to 60 participants at up to 10 sites. All eligible participants will undergo the implant procedure. Two-thirds of the participants will receive active stimulation (treatment) and the one-third will receive non-active stimulation (control). Following treatment evaluations at Week 48, there will be a one-way crossover of control subjects to active stimulation and a 48-week open-label follow-up with all subjects (treatment and control) receiving active stimulation to evaluate long-term safety.
PhaseNA
TypeInterventional
Age22 Years – 50 Years
WhereAtlanta, Georgia, United States + 5 more
SponsorSetPoint Medical Corporation
▾Tap for detailsClick for full details — eligibility, all locations, contacts Confirmatory Trial for Alleviating Fatigue in Multiple Sclerosis
NCT06441617 ·
Multiple Sclerosis, Fatigue
RecruitingCAFE-MS will assess the effectiveness of two online programs for fatigue in multiple sclerosis (MS). Although they differ, both of these online programs contain information about MS and fatigue intended to help people with MS understand and manage their fatigue. This large-scale, decentralized clinical trial is projected to enroll 2,000 people with MS. The collaboration between iConquerMS and 5 Veterans Affairs (VA) sites in the MS Centers of Excellence is designed to ensure sufficient representation of people with MS from populations traditionally under-represented in MS clinical trials. The study is a 3-arm, randomized controlled clinical trial with study participation lasting 1 year. Two of the trial arms will include one of two online programs for managing fatigue in MS added to the trial participants' usual MS treatment, and the third arm will include usual MS treatment alone. The online program phase of the trial lasts for 6 months after randomization followed by a final study visit at 12 months. Participants in the usual MS treatment alone arm for the first 6 months will have an opportunity to choose one of the online programs for the final 6 months of the trial.
PhaseNA
TypeInterventional
Age22 Years
WhereWashington D.C., District of Columbia, United States + 5 more
SponsorAccelerated Cure Project for Multiple Sclerosis
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Assess Bioequivalence of Two Subcutaneous (SC) Formulations of Ocrelizumab in Participants With Multiple Sclerosis (MS)
RecruitingThe main purpose of this study is to assess the bioequivalence of ocrelizumab SC test formulation to the marketed ocrelizumab SC reference formulation in participants with either relapsing multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS). The study consists of 2 phases: a controlled phase, where participants in each group will receive one dose of test or reference formulation and a continuation phase, where all participants in both groups will receive ocrelizumab SC test formulation.
PhasePhase 2
TypeInterventional
Age18 Years – 65 Years
WhereCarlsbad, California, United States + 55 more
SponsorHoffmann-La Roche
▾Tap for detailsClick for full details — eligibility, all locations, contacts Factorial Optimization Trial to Test Cognitive Behavioral Therapy Components for Multiple Sclerosis Fatigue
RecruitingThis randomized controlled factorial trial will examine whether and how relaxation training, behavioral activation, and cognitive therapy improve fatigue and functioning in fatigued adults living with multiple sclerosis.
PhaseNA
TypeInterventional
Age18 Years
WhereSeattle, Washington, United States
SponsorUniversity of Washington
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis
RecruitingThe purpose of this study is to provide efficacy and safety data for remibrutinib in patients with secondary progressive multiple sclerosis (SPMS)
PhasePhase 3
TypeInterventional
Age18 Years – 65 Years
WhereBirmingham, Alabama, United States + 207 more
SponsorNovartis Pharmaceuticals
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of AZD0120 in Autoimmune Diseases
NCT07295847 · Systemic Sclerosis, Idiopathic Inflammatory Myopathies,
Rheumatoid Arthritis RecruitingThis trial is a Phase 1b, open-label, multi-center, clinical study of AZD0120, a BCMA/CD19 dual targeting CAR+ T-cell therapy, to evaluate the safety and tolerability in adult participants with systemic sclerosis (SSc), idiopathic inflammatory myopathies (IIM), or difficult-to-treat rheumatoid arthritis (D2T RA).
PhasePhase 1
TypeInterventional
Age18 Years – 75 Years
WhereTucson, Arizona, United States + 17 more
SponsorAstraZeneca
▾Tap for detailsClick for full details — eligibility, all locations, contacts Best Available Therapy Versus Autologous Hematopoietic Stem Cell Transplant for Multiple Sclerosis (BEAT-MS)
RecruitingThis is a multi-center prospective rater-masked (blinded) randomized controlled trial of 156 participants, comparing the treatment strategy of Autologous Hematopoietic Stem Cell Transplantation (AHSCT) to the treatment strategy of Best Available Therapy (BAT) for treatment-resistant relapsing multiple sclerosis (MS). Participants will be randomized at a 1 to 1 (1:1) ratio. All participants will be followed for 72 months after randomization (Day 0, Visit 0).
PhasePhase 3
TypeInterventional
Age18 Years – 55 Years
WherePalo Alto, California, United States + 21 more
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
▾Tap for detailsClick for full details — eligibility, all locations, contacts Increasing Physical Activity for Adults With Multiple Sclerosis (MS)
NCT06270641 ·
Multiple Sclerosis (MS), Fatigue, Physical Inactivity
RecruitingThis study aims to advance the scientific understanding and potential future implementation of physical activity promotion by testing the efficacy of a phone-based app for increasing activity in insufficiently active patients with multiple sclerosis (MS).
PhaseNA
TypeInterventional
Age18 Years
WhereSeattle, Washington, United States
SponsorUniversity of Washington
▾Tap for detailsClick for full details — eligibility, all locations, contacts Study to Evaluate Safety, Efficacy and Pharmacokinetics (PK) of a Modified Regimen of Ublituximab
RecruitingThe primary purpose of this phase 3b study is to assess the efficacy of a modified regimen of ublituximab in participants with relapsing multiple sclerosis (RMS) as measured by T1 Gadolinium (Gd)-enhancing lesions in Part A; PK in Part B along with efficacy of ublituximab as measured by T1 Gd-enhancing lesions in participants who had a suboptimal experience on prior anti-CD20 therapy in Part C. The study consists of 3 parts: Part A is single-armed and open-label, Part B is randomized, double-blind, placebo-controlled, and Part C is single-armed and open-label.
PhasePhase 3
TypeInterventional
Age18 Years – 65 Years
WhereBirmingham, Alabama, United States + 46 more
SponsorTG Therapeutics, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts