Efficacy and Safety of Masitinib in the Treatment of Progressive Multiple Sclerosis

Phase 3

Completed

• Conditions: Multiple Sclerosis, Secondary Progressive; Multiple Sclerosis, Primary Progressive; Multiple Sclerosis, Relapse Free
• Interventions: Drug: Masitinib; Drug: Placebo

• Registration Number: NCT01433497
• Lead Sponsor: AB Science

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 secondary progressive multiple sclerosis.

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 subsequent modulation of inflammatory and neurodegenerative processes. The objective of this study is to compare the efficacy and safety of masitinib at 4.5 mg/kg/day versus matched placebo, or masitinib at 4.5 mg/kg/day with a dose escalation to 6 mg/kg/day after 3 months of treatment versus matched placebo, in the treatment of patients with primary progressive multiple sclerosis or relapse-free secondary progressive multiple sclerosis. Approximately 600 patients will be randomized into four treatment groups with a 2:2:1:1 design. The primary outcome measure is the Expanded Disability Status Scale (EDSS) after 96 weeks of treatment in the overall study population with subgroup analysis performed in stratum (primary progressive multiple sclerosis / secondary progressive multiple sclerosis).

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-09-12
• Study First Submitted QC: 2011-09-13
• Study First Posted: 2011-09-14
• Primary Completion: 2019-09
• Study Completion: 2020-02
• Disposition First Submitted: 2020-03-30
• Disposition First Submitted QC: 2020-03-30
• Status Verified: 2020-04
• Disposition First Posted: 2020-04-03
• Last Update Submitted: 2020-04-03
• Last Update Posted: 2020-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 656

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Arm A	Masitinib	Participants receive masitinib (4.5 mg/kg/day), given orally twice daily.
Experimental Arm B	Masitinib	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.
Placebo Comparator A	Placebo	Participants receive placebo given orally twice daily.
Placebo Comparator B	Placebo	Participants receive placebo, given orally twice daily, with a matched dose escalation after 3 months of treatment.

Primary Outcome Measures

Name	Time	Method
EDSS	96 weeks	Expanded Disability Status Scale (EDSS) after 96 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
MSFC	96 weeks	Multiple Sclerosis Functional Composite (MSFC)
MSQOL-54	96 weeks	Multiple Sclerosis Quality of Life 54 items (MSQOL-54)

Trial Locations

Locations (8)

Hôpital de Gui de Chauliac; 🇫🇷 Montpellier, France

"St. Ivan Rilski" University Multiprofile Hospital for Active Treatment; 🇧🇬 Sofia, Bulgaria

GHICL hopital ST vincent de Paul; 🇫🇷 Lille, France

Rehibilitation Center "KENTAVROS"; 🇬🇷 Volos, Greece

Universitätsklinikum Gießen und Marburg; 🇩🇪 Marburg, Germany

Centrul Medical Clubul Sănătăţii; 🇷🇴 Campulung, Romania

KO-MED Centra Kliniczne Lublin II; 🇵🇱 Lublin, Poland

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain