Efficacy and Safety of Masitinib in the Treatment of Progressive Multiple Sclerosis
Multiple Sclerosis, Secondary Progressive, Multiple Sclerosis, Primary Progressive, Multiple Sclerosis, Relapse Free
About this trial
This is an interventional treatment trial for Multiple Sclerosis, Secondary Progressive focused on measuring multiple sclerosis, primary progressive, relapse-free, secondary progressive
Eligibility Criteria
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
Sites / Locations
- "St. Ivan Rilski" University Multiprofile Hospital for Active Treatment
- GHICL hopital ST vincent de Paul
- Hôpital de Gui de Chauliac
- Universitätsklinikum Gießen und Marburg
- Rehibilitation Center "KENTAVROS"
- KO-MED Centra Kliniczne Lublin II
- Centrul Medical Clubul Sănătăţii
- Hospital de la Santa Creu i Sant Pau
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Placebo Comparator
Placebo Comparator
Experimental Arm A
Experimental Arm B
Placebo Comparator A
Placebo Comparator B
Participants receive masitinib (4.5 mg/kg/day), given orally twice daily.
Participants receive masitinib (4.5 mg/kg/day), given orally twice daily, with a dose escalation to 6 mg/kg/day after 3 months of treatment.
Participants receive placebo given orally twice daily.
Participants receive placebo, given orally twice daily, with a matched dose escalation after 3 months of treatment.