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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01433497
Recruitment Status : Completed
First Posted : September 14, 2011
Last Update Posted : April 8, 2020
Sponsor:
Information provided by (Responsible Party):
AB Science

Tracking Information
First Submitted Date  ICMJE September 12, 2011
First Posted Date  ICMJE September 14, 2011
Last Update Posted Date April 8, 2020
Actual Study Start Date  ICMJE August 2011
Actual Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 5, 2018)
EDSS [ Time Frame: 96 weeks ]
Expanded Disability Status Scale (EDSS) after 96 weeks of treatment
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2011)
Multiple Sclerosis Functional Composite (MSFC) [ Time Frame: week 96 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 5, 2018)
  • MSQOL-54 [ Time Frame: 96 weeks ]
    Multiple Sclerosis Quality of Life 54 items (MSQOL-54)
  • MSFC [ Time Frame: 96 weeks ]
    Multiple Sclerosis Functional Composite (MSFC)
Original Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2011)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Masitinib in the Treatment of Progressive Multiple Sclerosis
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Multiple Sclerosis, Secondary Progressive
  • Multiple Sclerosis, Primary Progressive
  • Multiple Sclerosis, Relapse Free
Intervention  ICMJE
  • Drug: Masitinib
    Other Name: AB1010
  • Drug: Placebo
    Other Name: Placebo Oral Tablet
Study Arms  ICMJE
  • Experimental: Experimental Arm A
    Participants receive masitinib (4.5 mg/kg/day), given orally twice daily.
    Intervention: Drug: Masitinib
  • 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.
    Intervention: Drug: Masitinib
  • Placebo Comparator: Placebo Comparator A
    Participants receive placebo given orally twice daily.
    Intervention: Drug: Placebo
  • Placebo Comparator: Placebo Comparator B
    Participants receive placebo, given orally twice daily, with a matched dose escalation after 3 months of treatment.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 5, 2018)
656
Original Estimated Enrollment  ICMJE
 (submitted: September 13, 2011)
450
Actual Study Completion Date  ICMJE February 2020
Actual Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bulgaria,   France,   Germany,   Greece,   Poland,   Romania,   Spain
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT01433497
Other Study ID Numbers  ICMJE AB07002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AB Science
Study Sponsor  ICMJE AB Science
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Patrick Vermersch, MD, PhD Hôpital Salengro, Lille, France
PRS Account AB Science
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP