Masitinib in Primary Progressive Multiple Sclerosis or Relapse-free Secondary Progressive Multiple Sclerosis

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the activity of oral AB1010, administered at two dose levels during 3 years to patients with primary or secondary progressive multiple sclerosis.

Official Title
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A Phase 2a, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Activity of Oral AB1010 Administered at 2 Dose Levels to Patients With Primary Progressive or Relapse-free Secondary Progressive Multiple Sclerosis

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Drug: masitinib
* Drug: masitinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 18 to 60 years, from both sex, and suffering from multiple sclerosis either primary progressive or secondary progressive without relapse within 2 years before inclusion. Patients with EDSS score in the range of 2 to 6.5, inclusive EDSS progression ≥ 1 point within 2 years before inclusion Exclusion Criteria: Disease other than MS responsible for clinical signs and/or MRI lesions Secondary progressive MS with relapse in the 2 years before inclusion Treatment with interferon or glatiramer acetate within four weeks prior to treatment allocation Treatment with oral or systemic corticosteroids or ACTH within four weeks prior to treatment allocation. Active current bacterial, viral (including hepatitis B and C, HIV, EBV, CMV, herpes zoster, herpes simplex), fungal, mycobacterium, protozoan, or other infection

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: masitinib 3 mg/kg/day<br> | Drug: masitinib<br>* masitinib 3 mg/kg/day<br>|
| Experimental: masitinib 6 mg/kg/day<br> | Drug: masitinib<br>* masitinib 6 mg/kg/day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in MSFC | average change in multiple sclerosis functional composite (MSFC) score relative to baseline, with clinical response defined as a > 100% improvement (increase) from baseline | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MSFC subcategories | timed 25-foot walk (T25FW) | 12 months | 
| Expanded Disability Status Scale (EDSS) |  | 12 months | 
| MFSC subcategories | 9-Hole Peg Test (9-HPT) | 12 months | 
| MFSC subcategories | Paced Auditory Addition Test (PASAT-3'') | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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relapse-free secondary progressive multiple sclerosis, primary progressive multiple sclerosis