Multiple Sclerosis Clinical Trial
Official title:
Efficacy, Safety and Tolerability of Atorvastatin 40 mg in Patients With Relapsing-remitting Multiple Sclerosis Treated With Interferon-beta-1b.SWiss Atorvastatin and Interferon-Beta 1b Trial In Multiple Sclerosis.
Title: Efficacy, safety and tolerability of Atorvastatin 40 mg in patients with
relapsing-remitting multiple sclerosis treated with interferon-beta-1b SWiss Atorvastatin
and Interferon-Beta 1b Trial In Multiple Sclerosis
Short title: "SWABIMS"
Study phase: Phase IIb study
Study design: Multi-center, randomized, rater-blinded, parallel-group-study in Switzerland
Investigational product: Atorvastatin 40mg every day (oral) plus Interferon-beta
Reference product: Interferon-beta-1b 250mg given
Indication: Relapsing-remitting multiple sclerosis (RR-MS)
Study objectives: Comparison of efficacy, safety and tolerability of combination of
Atorvastatin 40mg (per os) daily and Interferon-beta-1b e.o.d in patients with
relapsing-remitting multiple sclerosis compared to monotherapy with Interferon-beta-1b
e.o.d.
Primary Endpoint: Proportion of patients with new T2 lesions after 15 months of treatment.
Background
Multiple sclerosis is considered to be a chronic inflammatory demyelinating autoimmune
disease of the central nervous system. Statins are lipid-lowering drugs which inhibit the
3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA-) reductase, which is the main regulatory
enzyme of cholesterol biosynthesis. In recent years many studies have demonstrated, that
statins have anti-inflammatory and immunomodulatory properties in addition to their
lipid-lowering effects. Therefore, statins seem to have therapeutic potential in
immune-mediated disorders such as multiple sclerosis. Studies in experimental allergic
encephalomyelitis (EAE), the animal model for the human demyelinating disease multiple
sclerosis, as well as smaller studies in patients with relapsing-remitting multiple
sclerosis showed beneficial effect on the course of the disease. But there are also reports
of negative impact of statins on multiple sclerosis. Therefore, bigger studies are needed to
investigate the therapeutical potential of statins in multiple sclerosis.
Objective
The objectives of this study are to assess the efficacy, safety and tolerability of the
combination of Atorvastatin 40mg p.o. daily and Interferon-beta-1b sc e.o.d compared to
monotherapy with Interferon-beta-1b sc e.o.d in patients with relapsing-remitting multiple
sclerosis.
Methods
Multi-center, rater-blinded, parallel-group, two arm, randomized study. Patients with
relapsing-remitting forms of MS, respecting all inclusion/exclusion criteria, will be
randomized into two equal-size parallel arms after three months of treatment with
Interferon-beta-1b, receiving Atorvastatin 40mg/d or not. Enrolment of 80 patients (1/2 in
the Atorvastatin group) is planned. Patients providing written informed consent will be
treated for 15 months.
Inclusion criteria: Patients with relapsing-remitting forms of multiple sclerosis with
disease duration > 3 month and < 5 years, at least 1 relapse in the past two years, > 3
Lesions on spinal or brain-MRI, EDSS score between 0 and 3.5, inclusive, age between 18 and
55 years.
Exclusion criteria: Any disease other than multiple sclerosis that would better explain the
patient's signs and symptoms, Primary progressive MS, Secondary progressive MS, and others.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
| 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 |