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 Details — Status: Completed

Administrative data

• NCT number: NCT01433497
• Other study ID #: AB07002
• Status: Completed
• Phase: Phase 3
• Start date: August 2011
• Est. completion date: February 2020

Study information

• Verified date: April 2020
• Source: AB Science
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 656
• Est. completion date: February 2020
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Chronic Progressive
• Multiple Sclerosis, Primary Progressive
• Multiple Sclerosis, Relapse Free
• Multiple Sclerosis, Secondary Progressive
• Neoplasm Metastasis
• Recurrence
• Sclerosis

Intervention

Drug:
• Masitinib

• Placebo

Locations

Country	Name	City	State
Bulgaria	"St. Ivan Rilski" University Multiprofile Hospital for Active Treatment	Sofia
France	GHICL hopital ST vincent de Paul	Lille
France	Hôpital de Gui de Chauliac	Montpellier
Germany	Universitätsklinikum Gießen und Marburg	Marburg
Greece	Rehibilitation Center "KENTAVROS"	Volos
Poland	KO-MED Centra Kliniczne Lublin II	Lublin
Romania	Centrul Medical Clubul Sanatatii	Campulung
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
AB Science

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EDSS	Expanded Disability Status Scale (EDSS) after 96 weeks of treatment	96 weeks
Secondary	MSQOL-54	Multiple Sclerosis Quality of Life 54 items (MSQOL-54)	96 weeks
Secondary	MSFC	Multiple Sclerosis Functional Composite (MSFC)	96 weeks