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

• ClinicalTrials.gov Identifier: NCT01433497
• Recruitment Status: Completed
• First Posted: September 14, 2011
• Last Update Posted: April 8, 2020
• Sponsor: AB Science
• Information provided by (Responsible Party): AB Science

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 (Clinical Trial)
• 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: August 2011
• Actual Primary Completion Date: September 2019
• Actual Study Completion Date: February 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 Name: 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 Name: AB1010
Placebo Comparator: Placebo Comparator A; Participants receive placebo given orally twice daily.	Drug: Placebo; Other Name: 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 Name: Placebo Oral Tablet

Outcome Measures

Primary Outcome Measures :

1. EDSS [ Time Frame: 96 weeks ]
   Expanded Disability Status Scale (EDSS) after 96 weeks of treatment

Secondary Outcome Measures :

1. MSQOL-54 [ Time Frame: 96 weeks ]
   Multiple Sclerosis Quality of Life 54 items (MSQOL-54)
2. MSFC [ Time Frame: 96 weeks ]
   Multiple Sclerosis Functional Composite (MSFC)

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Bulgaria

"St. Ivan Rilski" University Multiprofile Hospital for Active Treatment

Sofia, Bulgaria, 1431

France

GHICL hopital ST vincent de Paul

Lille, France, 59020

Hôpital de Gui de Chauliac

Montpellier, France, 34295

Germany

Universitätsklinikum Gießen und Marburg

Marburg, Germany, D-35033

Greece

Rehibilitation Center "KENTAVROS"

Volos, Greece, 382 21

Poland

KO-MED Centra Kliniczne Lublin II

Lublin, Poland, 20-362

Romania

Centrul Medical Clubul Sănătăţii

Campulung, Romania, 115100

Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain, 08041

Sponsors and Collaborators

AB Science

Investigators

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

More Information

• Responsible Party: AB Science
• ClinicalTrials.gov Identifier: NCT01433497
• Other Study ID Numbers: AB07002
• First Posted: September 14, 2011
• Last Update Posted: April 8, 2020
• Last Verified: April 2020

Keywords provided by AB Science:

multiple sclerosis; primary progressive; relapse-free; secondary progressive

Additional relevant MeSH terms:

Neoplasm Metastasis; Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive; Sclerosis; Recurrence; Pathologic Processes; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Neoplastic Processes; Neoplasms; Disease Attributes