Masitinib in Primary Progressive Multiple Sclerosis or Relapse-free Secondary Progressive Multiple Sclerosis
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
1 other identifier
interventional
35
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 multiple-sclerosis
Started Jun 2005
Longer than P75 for phase_2 multiple-sclerosis
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 6, 2011
CompletedFirst Posted
Study publicly available on registry
October 12, 2011
CompletedDecember 11, 2018
December 1, 2018
2.1 years
October 6, 2011
December 8, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
12 months
Secondary Outcomes (4)
MSFC subcategories
12 months
Expanded Disability Status Scale (EDSS)
12 months
MFSC subcategories
12 months
MFSC subcategories
12 months
Study Arms (2)
masitinib 3 mg/kg/day
EXPERIMENTALmasitinib 6 mg/kg/day
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Patients with EDSS score in the range of 2 to 6.5, inclusive
You may not qualify if:
- Disease other than MS responsible for clinical signs and/or MRI lesions
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AB Sciencelead
Related Publications (1)
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.
PMID: 22691628RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 6, 2011
First Posted
October 12, 2011
Study Start
June 1, 2005
Primary Completion
July 1, 2007
Study Completion
January 1, 2010
Last Updated
December 11, 2018
Record last verified: 2018-12