Clinical trial NCT01433497: Efficacy and Safety of Masitinib in the Treatment of Progressive Multiple Sclerosis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Sclerosis, Secondary Progressive
Multiple Sclerosis, Primary Progressive
Multiple Sclerosis, Relapse Free
Keywords: multiple sclerosis
primary progressive
relapse-free
secondary progressive
Lead sponsor: AB Science
Sponsor class: INDUSTRY
First posted: 2011-09-14
Enrollment: 656
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: EDSS
timeFrame: 96 weeks
Secondary outcomes:
measure: MSQOL-54
timeFrame: 96 weeks
measure: MSFC
timeFrame: 96 weeks
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
facility: "St. Ivan Rilski" University Multiprofile Hospital for Active Treatment
city: Lille
country: France
facility: GHICL hopital ST vincent de Paul
city: Montpellier
country: France
facility: Hôpital de Gui de Chauliac
city: Marburg
country: Germany
facility: Universitätsklinikum Gießen und Marburg
city: Volos
country: Greece
facility: Rehibilitation Center "KENTAVROS"
city: Lublin
country: Poland
facility: KO-MED Centra Kliniczne Lublin II
city: Campulung
country: Romania
facility: Centrul Medical Clubul Sănătăţii
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
affiliation: Hôpital Salengro, Lille, France
name: Patrick Vermersch, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vermersch P, Brieva-Ruiz L, Fox RJ, Paul F, Ramio-Torrenta L, Schwab M, Moussy A, Mansfield C, Hermine O, Maciejowski M; AB07002 Study Group. Efficacy and Safety of Masitinib in Progressive Forms of Multiple Sclerosis: A Randomized, Phase 3, Clinical Trial. Neurol Neuroimmunol Neuroinflamm. 2022 Feb 21;9(3):e1148. doi: 10.1212/NXI.0000000000001148. Print 2022 May.