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

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ClinicalTrials.gov Identifier: NCT01433497
Recruitment Status : Active, not recruiting
First Posted : September 14, 2011
Last Update Posted : December 10, 2018
Sponsor:
Information provided by (Responsible Party):
AB Science

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 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
Study Start Date : August 2011
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


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




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)



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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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01433497


Locations
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

Responsible Party: AB Science
ClinicalTrials.gov Identifier: NCT01433497     History of Changes
Other Study ID Numbers: AB07002
First Posted: September 14, 2011    Key Record Dates
Last Update Posted: December 10, 2018
Last Verified: December 2018

Keywords provided by AB Science:
multiple sclerosis
primary progressive
relapse-free
secondary progressive

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Neoplasm Metastasis
Recurrence
Multiple Sclerosis, Chronic Progressive
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