Clinical Trials Logo
  1. Home
  2. Other
  3. NCT01433497

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

Multiple Sclerosis, Secondary Progressive Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01433497
Study type Interventional
Source AB Science
Contact
Status Completed
Phase Phase 3
Start date August 2011
Completion date February 2020
View Details
See also
  Status Clinical Trial Phase
Completed NCT03653585 - Cortical Lesions in Patients With Multiple Sclerosis
Recruiting NCT02273635 - Efficacy, Safety and Tolerability of Andrographolides Versus Placebo in Patients With Progressive Forms of MS Phase 1/Phase 2
Recruiting NCT05961644 - Cladribine vs Placebo for Non-active Progressive Multiple Sclerosis (CLASP-MS). Phase 2/Phase 3
Recruiting NCT05013463 - Hydroxychloroquine and Indapamide in SPMS Phase 2
Recruiting NCT04918225 - Motor Asymmetry in Progressive Multiple Sclerosis Patients
Completed NCT01982942 - Safety, Tolerability and Activity Study of Ibudilast in Subjects With Progressive Multiple Sclerosis Phase 2
Recruiting NCT05204459 - MS-ResearchBiomarkerS
Terminated NCT02430532 - BG00012 and Disability Progression in Secondary Progressive Multiple Sclerosis (SPMS) Phase 3
Completed NCT00888277 - Bayer/Cognitive Assessments With Multiple Sclerosis Subjects N/A
Recruiting NCT05663853 - An Observational Biomarker Study in Multiple Sclerosis (MS) Patients
Recruiting NCT05168384 - Safety and Efficacy of Extracorporeal Photopheresis (ECP) in the Treatment of Multiple Sclerosis Phase 1/Phase 2
Completed NCT02305264 - Imaging of Intracerebral Inflammation in MS N/A
Terminated NCT00468611 - Efficacy and Safety of MBP8298 in Subjects With Secondary Progressive Multiple Sclerosis Phase 3
Recruiting NCT05496881 - Exercise Effects in Multiple Sclerosis N/A
Completed NCT05357833 - Novel Imaging Markers in SPMS Early Phase 1
Completed NCT02506751 - Open-label Study of Liothyronine in MS Phase 1
Completed NCT00587691 - Dose-Escalation Study of T Cell Vaccine in Multiple Sclerosis Phase 1/Phase 2
Recruiting NCT04260711 - Discontinuing Disease-modifying Therapies in Stable Relapsing - Onset Multiple Sclerosis (DOT-MS). N/A
Completed NCT02308137 - Domperidone in Secondary Progressive Multiple Sclerosis (SPMS) Phase 2
Active, not recruiting NCT04993274 - Sensitivity of Motor Assessment in MS - a Prospective Cohort Study