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A Phase 2b/3 Study to Compare Efficacy and Safety of Masitinib to Placebo in the Treatment of Patients With Primary Progressive or Relapse-free Secondary Progressive Multiple Sclerosis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2013 by AB Science.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
AB Science Identifier:
First received: September 12, 2011
Last updated: August 13, 2013
Last verified: August 2013
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 Intervention Phase
Multiple Sclerosis, Secondary Progressive
Multiple Sclerosis, Primary Progressive
Multiple Sclerosis, Relapse Free
Drug: masitinib
Drug: placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 96 Week, Prospective, Multicentre, Randomized, Double-blind, Placebo-controlled, 2 Parallel-groups, Phase 2b/3 Study to Compare Efficacy and Safety of Masitinib 6 mg/kg/Day Versus Placebo in the Treatment of Patients With Primary Progressive or Relapse-free Secondary Progressive Multiple Sclerosis

Resource links provided by NLM:

Further study details as provided by AB Science:

Primary Outcome Measures:
  • Multiple Sclerosis Functional Composite (MSFC) [ Time Frame: week 96 ]

Secondary Outcome Measures:
  • EDSS [ Time Frame: week 96 ]
  • Multiple Sclerosis Quality of Life 54 items (MSQOL-54) [ Time Frame: week 96 ]
  • Timed 25-foot walk [ Time Frame: week 96 ]
  • Nine-hole peg test [ Time Frame: week 96 ]

Estimated Enrollment: 450
Study Start Date: August 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: masitinib
masitinib 6 mg/kg/day
Drug: masitinib
6 mg/kg/day
Placebo Comparator: placebo Drug: placebo
masitinib matching placebo


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. 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
  2. Patient with EDSS score of [2.0 to 6.0] inclusive at baseline
  3. Patient who had an EDSS score progression ≥ 1 point confirmed by a second evaluation carried out at least 6 months apart, within 2 years before inclusion

Exclusion Criteria:

  1. Patient suffering from a disease other than MS that would better explain the patient's neurological clinical signs and symptoms and/or MRI lesions
  2. Patient in who MRI examination and injection of gadolinium contrast agents should not be used
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01433497

Contact: Patrick Vermersch, MD, PhD

Hospital de la Santa Creu i Sant Pau Recruiting
Barcelona, Spain, 08041
Sponsors and Collaborators
AB Science
  More Information

Responsible Party: AB Science Identifier: NCT01433497     History of Changes
Other Study ID Numbers: AB07002
Study First Received: September 12, 2011
Last Updated: August 13, 2013

Keywords provided by AB Science:
multiple sclerosis
primary progressive
secondary progressive

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Chronic Progressive
Neoplasm Metastasis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Neoplastic Processes
Disease Attributes processed this record on March 30, 2017