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

AB Science

Status and phase: Completed; Phase 3

Conditions: Multiple Sclerosis, Secondary Progressive; Multiple Sclerosis, Primary Progressive; Multiple Sclerosis, Relapse Free

Treatments: Drug: Masitinib; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01433497

AB07002

Details and patient eligibility

About

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.

Full 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).

Enrollment: 656 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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656 participants in 4 patient groups, including a placebo group

Experimental Arm A

Experimental group

Description:

Participants receive masitinib (4.5 mg/kg/day), given orally twice daily.

Treatment:

Drug: Masitinib

Experimental Arm B

Experimental group

Description:

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.

Treatment:

Drug: Masitinib

Placebo Comparator A

Placebo Comparator group

Description:

Participants receive placebo given orally twice daily.

Treatment:

Drug: Placebo

Placebo Comparator B

Placebo Comparator group

Description:

Participants receive placebo, given orally twice daily, with a matched dose escalation after 3 months of treatment.

Treatment:

Drug: Placebo