Status:
COMPLETED
Efficacy and Safety of Masitinib in the Treatment of Progressive Multiple Sclerosis
Lead Sponsor:
AB Science
Conditions:
Multiple Sclerosis, Secondary Progressive
Multiple Sclerosis, Primary Progressive
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare the safety and efficacy of masitinib 6 mg/kg/day versus placebo in the treatment of patients with primary progressive multiple sclerosis or relapse-free seconda...
Detailed Description
Masitinib is a selective tyrosine kinase inhibitor that is thought to exert a neuroprotective effect through its activity on mast cells and other non-neuronal cells of the central nervous system, with...
Eligibility Criteria
Inclusion
- Main inclusion criteria:
- \- Patient suffering from either primary progressive or secondary progressive multiple sclerosis without relapse within 2 years before inclusion according to the revised McDonald's criteria.
- Main exclusion criteria:
- \- Patient suffering from a disease other than MS that would better explain the patient's neurological clinical signs and symptoms and/or MRI lesions
Exclusion
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2020
Estimated Enrollment :
656 Patients enrolled
Trial Details
Trial ID
NCT01433497
Start Date
August 1 2011
End Date
February 1 2020
Last Update
April 8 2020
Active Locations (8)
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1
"St. Ivan Rilski" University Multiprofile Hospital for Active Treatment
Sofia, Bulgaria, 1431
2
GHICL hopital ST vincent de Paul
Lille, France, 59020
3
Hôpital de Gui de Chauliac
Montpellier, France, 34295
4
Universitätsklinikum Gießen und Marburg
Marburg, Germany, D-35033