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

April 3, 2020 updated by: AB Science

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

656

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Sofia, Bulgaria, 1431
        • "St. Ivan Rilski" University Multiprofile Hospital for Active Treatment
  • France
      • Lille, France, 59020
        • GHICL hopital ST vincent de Paul
      • Montpellier, France, 34295
        • Hôpital de Gui de Chauliac
  • Germany
      • Marburg, Germany, D-35033
        • Universitätsklinikum Gießen und Marburg
  • Greece
      • Volos, Greece, 382 21
        • Rehibilitation Center "KENTAVROS"
  • Poland
      • Lublin, Poland, 20-362
        • KO-MED Centra Kliniczne Lublin II
  • Romania
      • Campulung, Romania, 115100
        • Centrul Medical Clubul Sanatatii
  • Spain
      • Barcelona, Spain, 08041
        • Hospital de la Santa Creu i Sant Pau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EDSS
Time Frame: 96 weeks
Expanded Disability Status Scale (EDSS) after 96 weeks of treatment
96 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AB Science

Investigators

  • Principal Investigator: Patrick Vermersch, MD, PhD, Hôpital Salengro, Lille, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2011

Primary Completion (Actual)

September 1, 2019

Study Completion (Actual)

February 1, 2020

Study Registration Dates

First Submitted

September 12, 2011

First Submitted That Met QC Criteria

September 13, 2011

First Posted (Estimate)

September 14, 2011

Study Record Updates

Last Update Posted (Actual)

April 8, 2020

Last Update Submitted That Met QC Criteria

April 3, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AB07002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Multiple Sclerosis, Secondary Progressive

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Romania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe