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

A 96 Week, Prospective, Multicentre, Randomized, Double-blind, Placebo-controlled, 2 Parallel-groups, Phase 3 Study to Compare Efficacy and Safety of Masitinib 4.5 mg/kg/Day Versus Placebo in the Treatment of Patients With Primary Progressive or Relapse-free Secondary Progressive Multiple Sclerosis

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01433497

Enrollment

656

Registered

2011-09-14

Start date

2011-08-31

Completion date

2020-02-29

Last updated

2020-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis, Primary Progressive, Multiple Sclerosis, Relapse Free, Multiple Sclerosis, Secondary Progressive

Keywords

multiple sclerosis, primary progressive, relapse-free, secondary progressive

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).

Interventions

DRUGMasitinib

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame	Description
EDSS	96 weeks	Expanded Disability Status Scale (EDSS) after 96 weeks of treatment

Secondary

Measure	Time frame	Description
MSFC	96 weeks	Multiple Sclerosis Functional Composite (MSFC)
MSQOL-54	96 weeks	Multiple Sclerosis Quality of Life 54 items (MSQOL-54)

Countries

Bulgaria, France, Germany, Greece, Poland, Romania, Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026