Multiple Sclerosis Clinical Trial
Official title:
Effect of Natalizumab (Tysabri®) on Remyelination in Patients With Relapsing-remitting Multiple Sclerosis. A Follow-up Voxel-wise Magnetization Transfer Imaging Study.
The primary objective of this study is to define the effect of Tysabri in patients with
relapsing-remitting (RR) multiple sclerosis (MS) over 2 years. The investigators will also
explore the extent of remyelination in MS patients treated with Tysabri over 2 years.
A secondary objective of this study is to investigate differences in the capacity for
remyelination between patients who do or do not respond to Tysabri monotherapy during the
same 24 months.
A tertiary objective of this study is to monitor Tysabri effect in MS antiphospholipid
antibodies positive and MS antiphospholipid antibodies negative patients and to determine
perfusion differences according to the antiphospholipid antibodies positivity status.
Magnetization transfer imaging (MTI) is a widely used tool for characterizing the evolution
of multiple sclerosis (MS) lesions and normal appearing brain tissue (NABT). As
remyelination and demyelination are heterogeneous in each lesion and NABT, techniques such
as voxel-wise based MTR dynamic mapping may help predict an individual's clinical course, as
well as the effect of treatment, by revealing evidence of myelin repair and neuroprotection.
Natalizumab (Tysabri) showed a robust effect on the decrease of inflammation in phase II and
III clinical trials, as evidenced by the decrease in Gd enhancing and T2 lesions and on the
decrease of clinical activity as measured by reduction of clinical relapses and progression
of disability. The effect of Tysabri on non-conventional measures is only partially known.
;
Observational Model: Case Control, Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05528666 -
Risk Perception in Multiple Sclerosis
|
||
| Completed |
NCT03608527 -
Adaptive Plasticity Following Rehabilitation in Multiple Sclerosis
|
N/A | |
| Recruiting |
NCT05532943 -
Evaluate the Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cells in Patients With Multiple Sclerosis
|
Phase 1/Phase 2 | |
| Completed |
NCT02486640 -
Evaluation of Potential Predictors of Adherence by Investigating a Representative Cohort of Multiple Sclerosis (MS) Patients in Germany Treated With Betaferon
|
||
| Completed |
NCT01324232 -
Safety and Efficacy of AVP-923 in the Treatment of Central Neuropathic Pain in Multiple Sclerosis
|
Phase 2 | |
| Completed |
NCT04546698 -
5-HT7 Receptor Implication in Inflammatory Mechanisms in Multiple Sclerosis
|
||
| Active, not recruiting |
NCT04380220 -
Coagulation/Complement Activation and Cerebral Hypoperfusion in Relapsing-remitting Multiple Sclerosis
|
||
| Completed |
NCT02835677 -
Integrating Caregiver Support Into MS Care
|
N/A | |
| Completed |
NCT03686826 -
Feasibility and Reliability of Multimodal Evoked Potentials
|
||
| Recruiting |
NCT05964829 -
Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis
|
N/A | |
| Withdrawn |
NCT06021561 -
Orofacial Pain in Multiple Sclerosis
|
||
| Completed |
NCT03653585 -
Cortical Lesions in Patients With Multiple Sclerosis
|
||
| Recruiting |
NCT04798651 -
Pathogenicity of B and CD4 T Cell Subsets in Multiple Sclerosis
|
N/A | |
| Active, not recruiting |
NCT05054140 -
Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients With Progressive Multiple Sclerosis
|
Phase 2 | |
| Completed |
NCT05447143 -
Effect of Home Exercise Program on Various Parameters in Patients With Multiple Sclerosis
|
N/A | |
| Recruiting |
NCT06195644 -
Effect of Galvanic Vestibular Stimulation on Cortical Excitability and Hand Dexterity in Multiple Sclerosis Patients
|
Phase 1 | |
| Completed |
NCT04147052 -
iSLEEPms: An Internet-Delivered Intervention for Sleep Disturbance in Multiple Sclerosis
|
N/A | |
| Completed |
NCT03591809 -
Combined Exercise Training in Patients With Multiple Sclerosis
|
N/A | |
| Completed |
NCT03594357 -
Cognitive Functions in Patients With Multiple Sclerosis
|
||
| Completed |
NCT03269175 -
BENEFIT 15 Long-term Follow-up Study of the BENEFIT and BENEFIT Follow-up Studies
|
Phase 4 |