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

Sponsor

AB Science (Industry)

Overall Status

Completed

CT.gov ID

NCT01433497

Collaborator

(none)

656

Enrollment

Locations

Arms

102

Actual Duration (Months)

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis, Secondary Progressive Multiple Sclerosis, Primary Progressive Multiple Sclerosis, Relapse Free	Drug: Masitinib Drug: Placebo	Phase 3

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).

Study Design

Study Type:

Interventional

Actual Enrollment :

656 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Aug 1, 2011

Actual Primary Completion Date :

Sep 1, 2019

Actual Study Completion Date :

Feb 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental Arm A Participants receive masitinib (4.5 mg/kg/day), given orally twice daily.	Drug: Masitinib Other Names: AB1010
Experimental: Experimental Arm B 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.	Drug: Masitinib Other Names: AB1010
Placebo Comparator: Placebo Comparator A Participants receive placebo given orally twice daily.	Drug: Placebo Other Names: Placebo Oral Tablet
Placebo Comparator: Placebo Comparator B Participants receive placebo, given orally twice daily, with a matched dose escalation after 3 months of treatment.	Drug: Placebo Other Names: Placebo Oral Tablet

Outcome Measures

Primary Outcome Measures

EDSS [96 weeks]
Expanded Disability Status Scale (EDSS) after 96 weeks of treatment

Secondary Outcome Measures

MSQOL-54 [96 weeks]
Multiple Sclerosis Quality of Life 54 items (MSQOL-54)
MSFC [96 weeks]
Multiple Sclerosis Functional Composite (MSFC)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	"St. Ivan Rilski" University Multiprofile Hospital for Active Treatment	Sofia	Bulgaria	1431
2	GHICL hopital ST vincent de Paul	Lille	France	59020
3	Hôpital de Gui de Chauliac	Montpellier	France	34295
4	Universitätsklinikum Gießen und Marburg	Marburg	Germany	D-35033
5	Rehibilitation Center "KENTAVROS"	Volos	Greece	382 21
6	KO-MED Centra Kliniczne Lublin II	Lublin	Poland	20-362
7	Centrul Medical Clubul Sănătăţii	Campulung	Romania	115100
8	Hospital de la Santa Creu i Sant Pau	Barcelona	Spain	08041