Back to resultsMasitinib in Primary Progressive Multiple Sclerosis or Relapse-free Secondary Progressive Multiple Sclerosis
Primary Purpose
Multiple Sclerosis
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
masitinib
masitinib
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring primary progressive multiple sclerosis, relapse-free secondary progressive multiple sclerosis
Eligibility Criteria
Inclusion Criteria:
- Patients aged 18 to 60 years, from both sex, and suffering from multiple sclerosis either primary progressive or secondary progressive without relapse within 2 years before inclusion.
- Patients with EDSS score in the range of 2 to 6.5, inclusive
- EDSS progression ≥ 1 point within 2 years before inclusion
Exclusion Criteria:
- Disease other than MS responsible for clinical signs and/or MRI lesions
- Secondary progressive MS with relapse in the 2 years before inclusion
- Treatment with interferon or glatiramer acetate within four weeks prior to treatment allocation
- Treatment with oral or systemic corticosteroids or ACTH within four weeks prior to treatment allocation.
- Active current bacterial, viral (including hepatitis B and C, HIV, EBV, CMV, herpes zoster, herpes simplex), fungal, mycobacterium, protozoan, or other infection
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
masitinib 3 mg/kg/day
masitinib 6 mg/kg/day
Arm Description
Outcomes
Primary Outcome Measures
change in MSFC
average change in multiple sclerosis functional composite (MSFC) score relative to baseline, with clinical response defined as a > 100% improvement (increase) from baseline
Secondary Outcome Measures
MSFC subcategories
timed 25-foot walk (T25FW)
Expanded Disability Status Scale (EDSS)
MFSC subcategories
9-Hole Peg Test (9-HPT)
MFSC subcategories
Paced Auditory Addition Test (PASAT-3'')
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01450488
Brief Title
Masitinib in Primary Progressive Multiple Sclerosis or Relapse-free Secondary Progressive Multiple Sclerosis
Official Title
A Phase 2a, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Activity of Oral AB1010 Administered at 2 Dose Levels to Patients With Primary Progressive or Relapse-free Secondary Progressive Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AB Science
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the activity of oral AB1010, administered at two dose levels during 3 years to patients with primary or 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
Keywords
primary progressive multiple sclerosis, relapse-free secondary progressive multiple sclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
masitinib 3 mg/kg/day
Arm Type
Experimental
Arm Title
masitinib 6 mg/kg/day
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
masitinib
Intervention Description
masitinib 3 mg/kg/day
Intervention Type
Drug
Intervention Name(s)
masitinib
Intervention Description
masitinib 6 mg/kg/day
Primary Outcome Measure Information:
Title
change in MSFC
Description
average change in multiple sclerosis functional composite (MSFC) score relative to baseline, with clinical response defined as a > 100% improvement (increase) from baseline
Time Frame
12 months
Secondary Outcome Measure Information:
Title
MSFC subcategories
Description
timed 25-foot walk (T25FW)
Time Frame
12 months
Title
Expanded Disability Status Scale (EDSS)
Time Frame
12 months
Title
MFSC subcategories
Description
9-Hole Peg Test (9-HPT)
Time Frame
12 months
Title
MFSC subcategories
Description
Paced Auditory Addition Test (PASAT-3'')
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients aged 18 to 60 years, from both sex, and suffering from multiple sclerosis either primary progressive or secondary progressive without relapse within 2 years before inclusion.
Patients with EDSS score in the range of 2 to 6.5, inclusive
EDSS progression ≥ 1 point within 2 years before inclusion
Exclusion Criteria:
Disease other than MS responsible for clinical signs and/or MRI lesions
Secondary progressive MS with relapse in the 2 years before inclusion
Treatment with interferon or glatiramer acetate within four weeks prior to treatment allocation
Treatment with oral or systemic corticosteroids or ACTH within four weeks prior to treatment allocation.
Active current bacterial, viral (including hepatitis B and C, HIV, EBV, CMV, herpes zoster, herpes simplex), fungal, mycobacterium, protozoan, or other infection
12. IPD Sharing Statement
Citations:
PubMed Identifier
22691628
Citation
Vermersch P, Benrabah R, Schmidt N, Zephir H, Clavelou P, Vongsouthi C, Dubreuil P, Moussy A, Hermine O. Masitinib treatment in patients with progressive multiple sclerosis: a randomized pilot study. BMC Neurol. 2012 Jun 12;12:36. doi: 10.1186/1471-2377-12-36.
Results Reference
result
Links:
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3467179/
Description
Link to article
Learn more about this trial
Masitinib in Primary Progressive Multiple Sclerosis or Relapse-free Secondary Progressive Multiple Sclerosis
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