Relapsing-Remitting Multiple Sclerosis Clinical Trial
Official title:
A Multicenter, Randomized, Open-Label Study to Assess the Impact of Natalizumab Versus Fingolimod on Central Nervous System Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis Subjects
The primary objective of this study is to assess the effect of natalizumab compared to fingolimod on the evolution of new on-treatment T1-gadolinium-enhancing (Gd+) lesions to persistent black holes (PBH) over 52 weeks. The secondary objectives of this study in this study population are to assess the effect of natalizumab compared to fingolimod on: magnetic resonance imaging (MRI) measures of central nervous system (CNS) tissue destruction as measured by the number of new T1-Gd+ lesions; various other MRI measures of disease activity; No Evidence of Disease Activity (NEDA); Relapse on treatment over 52 weeks; The change in information processing speed as measured by the Symbol Digit Modalities Test (SDMT).
This study also includes a Diffusion Tensor Imaging (DTI) sub-study that includes healthy volunteers. Healthy volunteers will not receive any study medication. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02549703 -
Mitochondrial Dysfunction and Disease Progression
|
||
| Terminated |
NCT02222948 -
Efficacy and Safety of Vatelizumab in Patients With Relapsing-Remitting Multiple Sclerosis
|
Phase 2 | |
| Completed |
NCT02293967 -
Mass Balance Study of MT-1303
|
Phase 1 | |
| Terminated |
NCT01790269 -
Monitoring Natural Killer Cells in Multiple Sclerosis Patients Treated With Fingolimod
|
||
| Terminated |
NCT01701856 -
Natalizumab De-escalation to Interferon-beta-1b in Patients With Relapsing-remitting Multiple Sclerosis
|
Phase 4 | |
| Completed |
NCT00525668 -
Sunphenon Epigallocatechin-gallate (EGCg) in Relapsing-remitting Multiple Sclerosis (SuniMS Study)
|
Phase 1/Phase 2 | |
| Terminated |
NCT00398528 -
An fMRI Study of Treatment Optimization Comparing Two Disease Modifying Therapies Used to Treat Relapsing Remitting Multiple Sclerosis
|
Phase 4 | |
| Completed |
NCT00315367 -
A fMRI(Functional Magnetic Resonance Imaging) Research Study to Learn More About Multiple Sclerosis and Individuals Potentially Experiencing Memory Difficulties
|
Phase 4 | |
| Terminated |
NCT04032171 -
Study of Evobrutinib in Participants With RMS
|
Phase 3 | |
| Completed |
NCT01930708 -
A Study Evaluating the Effectiveness of Tecfidera (Dimethyl Fumarate) on Multiple Sclerosis (MS) Disease Activity and Patient-Reported Outcomes
|
Phase 4 | |
| Completed |
NCT03000647 -
Guided Versus Non-guided Pelvic Floor Exercises for Urinary Incontinence in Relapsing-Remitting Multiple Sclerosis
|
N/A | |
| Completed |
NCT02205489 -
Management Of The Infusion-Associated Reactions In RRMS Patients Treated With LEMTRADA
|
Phase 4 | |
| Completed |
NCT02753088 -
Efficacy and Safety of BCD-063 and Copaxone-Teva in Patients With Relapsing-Remitting Multiple Sclerosis
|
Phase 3 | |
| Recruiting |
NCT01466114 -
Estriol Treatment in Multiple Sclerosis (MS): Effect on Cognition
|
Phase 2 | |
| Completed |
NCT01416155 -
Extension Study to Evaluate Safety and Efficacy of Natalizumab in Japanese Participants With Relapsing-Remitting Multiple Sclerosis
|
Phase 2 | |
| Completed |
NCT01244139 -
Safety Study of BIIB033 in Subjects With Multiple Sclerosis
|
Phase 1 | |
| Completed |
NCT00559702 -
Safety Study of Natalizumab to Treat Multiple Sclerosis (MS)
|
Phase 1 | |
| Completed |
NCT00493116 -
Is IFN-beta Treatment in MS Useful After a Washout Period in Patients With Neutralizing Antibodies to Interferon Beta
|
Phase 4 | |
| Terminated |
NCT01706107 -
Canadian Multicenter Observational Study of Tysabri in Early Relapsing Remitting Multiple Sclerosis Participants
|
||
| Completed |
NCT01943526 -
Ireland Natalizumab (TYSABRI) Observational Program
|