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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

This study is currently recruiting participants.
Verified October 2012 by AB Science
Sponsor:
Information provided by (Responsible Party):
AB Science
ClinicalTrials.gov Identifier:
NCT01433497
First received: September 12, 2011
Last updated: October 1, 2012
Last verified: October 2012
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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:

U.S. FDA Resources

Further study details as provided by AB Science:

Primary Outcome Measures:
  • Multiple Sclerosis Functional Composite (MSFC) [ Time Frame: week 96 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • EDSS [ Time Frame: week 96 ] [ Designated as safety issue: No ]
  • Multiple Sclerosis Quality of Life 54 items (MSQOL-54) [ Time Frame: week 96 ] [ Designated as safety issue: No ]
  • Timed 25-foot walk [ Time Frame: week 96 ] [ Designated as safety issue: No ]
  • Nine-hole peg test [ Time Frame: week 96 ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01433497

Contacts
Contact: Patrick Vermersch, MD, PhD pvermersch@chru-lille.fr

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

No publications provided

Responsible Party: AB Science
ClinicalTrials.gov Identifier: NCT01433497     History of Changes
Other Study ID Numbers: AB07002
Study First Received: September 12, 2011
Last Updated: October 1, 2012
Health Authority: United States: Food and Drug Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Multiple Sclerosis
Recurrence
Sclerosis
Multiple Sclerosis, Chronic Progressive
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
 Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013