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

Primary Purpose

Multiple Sclerosis, Secondary Progressive, Multiple Sclerosis, Primary Progressive, Multiple Sclerosis, Relapse Free

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Masitinib
Placebo
Sponsored by
AB Science
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis, Secondary Progressive focused on measuring multiple sclerosis, primary progressive, relapse-free, secondary progressive

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • "St. Ivan Rilski" University Multiprofile Hospital for Active Treatment
  • GHICL hopital ST vincent de Paul
  • Hôpital de Gui de Chauliac
  • Universitätsklinikum Gießen und Marburg
  • Rehibilitation Center "KENTAVROS"
  • KO-MED Centra Kliniczne Lublin II
  • Centrul Medical Clubul Sănătăţii
  • Hospital de la Santa Creu i Sant Pau

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Arm Label

Experimental Arm A

Experimental Arm B

Placebo Comparator A

Placebo Comparator B

Arm Description

Participants receive masitinib (4.5 mg/kg/day), given orally twice daily.

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.

Participants receive placebo given orally twice daily.

Participants receive placebo, given orally twice daily, with a matched dose escalation after 3 months of treatment.

Outcomes

Primary Outcome Measures

EDSS
Expanded Disability Status Scale (EDSS) after 96 weeks of treatment

Secondary Outcome Measures

MSQOL-54
Multiple Sclerosis Quality of Life 54 items (MSQOL-54)
MSFC
Multiple Sclerosis Functional Composite (MSFC)

Full Information

First Posted
September 12, 2011
Last Updated
April 3, 2020
Sponsor
AB Science
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1. Study Identification

Unique Protocol Identification Number
NCT01433497
Brief Title
Efficacy and Safety of Masitinib in the Treatment of Progressive Multiple Sclerosis
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 Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
August 2011 (Actual)
Primary Completion Date
September 2019 (Actual)
Study Completion Date
February 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AB Science

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Secondary Progressive, Multiple Sclerosis, Primary Progressive, Multiple Sclerosis, Relapse Free
Keywords
multiple sclerosis, primary progressive, relapse-free, secondary progressive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
656 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Arm A
Arm Type
Experimental
Arm Description
Participants receive masitinib (4.5 mg/kg/day), given orally twice daily.
Arm Title
Experimental Arm B
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo Comparator A
Arm Type
Placebo Comparator
Arm Description
Participants receive placebo given orally twice daily.
Arm Title
Placebo Comparator B
Arm Type
Placebo Comparator
Arm Description
Participants receive placebo, given orally twice daily, with a matched dose escalation after 3 months of treatment.
Intervention Type
Drug
Intervention Name(s)
Masitinib
Other Intervention Name(s)
AB1010
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo Oral Tablet
Primary Outcome Measure Information:
Title
EDSS
Description
Expanded Disability Status Scale (EDSS) after 96 weeks of treatment
Time Frame
96 weeks
Secondary Outcome Measure Information:
Title
MSQOL-54
Description
Multiple Sclerosis Quality of Life 54 items (MSQOL-54)
Time Frame
96 weeks
Title
MSFC
Description
Multiple Sclerosis Functional Composite (MSFC)
Time Frame
96 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Vermersch, MD, PhD
Organizational Affiliation
Hôpital Salengro, Lille, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
"St. Ivan Rilski" University Multiprofile Hospital for Active Treatment
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
GHICL hopital ST vincent de Paul
City
Lille
ZIP/Postal Code
59020
Country
France
Facility Name
Hôpital de Gui de Chauliac
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Universitätsklinikum Gießen und Marburg
City
Marburg
ZIP/Postal Code
D-35033
Country
Germany
Facility Name
Rehibilitation Center "KENTAVROS"
City
Volos
ZIP/Postal Code
382 21
Country
Greece
Facility Name
KO-MED Centra Kliniczne Lublin II
City
Lublin
ZIP/Postal Code
20-362
Country
Poland
Facility Name
Centrul Medical Clubul Sănătăţii
City
Campulung
ZIP/Postal Code
115100
Country
Romania
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08041
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
35190477
Citation
Vermersch P, Brieva-Ruiz L, Fox RJ, Paul F, Ramio-Torrenta L, Schwab M, Moussy A, Mansfield C, Hermine O, Maciejowski M; AB07002 Study Group. Efficacy and Safety of Masitinib in Progressive Forms of Multiple Sclerosis: A Randomized, Phase 3, Clinical Trial. Neurol Neuroimmunol Neuroinflamm. 2022 Feb 21;9(3):e1148. doi: 10.1212/NXI.0000000000001148. Print 2022 May.
Results Reference
derived

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

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