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A Phase 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

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ClinicalTrials.gov Identifier: NCT01433497
Recruitment Status : Recruiting
First Posted : September 14, 2011
Last Update Posted : April 21, 2017
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 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 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 : January 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: masitinib
masitinib 4.5 mg/kg/day
Drug: masitinib
6 mg/kg/day
Placebo Comparator: placebo Drug: placebo
masitinib matching placebo



Primary Outcome Measures :
  1. EDSS [ Time Frame: week 96 ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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


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

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: April 21, 2017
Last Verified: April 2017

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

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