Masitinib in Primary Progressive Multiple Sclerosis or Relapse-free Secondary Progressive Multiple Sclerosis
What it found
The main measure did not show a significant benefit.
“This positive, albeit non-statistically significant response was observed as early as month-3 and sustained through to month-18, with similar trends seen in the PPMS and rfSPMS subpopulations.”Read by software from the paper's abstract
change relative to baseline in the multiple sclerosis functional composite score (MSFC) · month-12
| Group | n | Value |
|---|---|---|
| masitinib | 27 | +103% ± 189 at month-12 |
| placebo | 8 | -60% ± 190 at month-12 |
Read by software from the paper's abstract
What was tested
Treatment tested
- Masitinib
Fibroblast growth factor receptor 3 inhibitor|Platelet-derived growth factor receptor inhibitor|Stem cell growth factor receptor inhibitor
What it measured
Main measures
change in MSFC
12 months
Disability progression
Other measures (3)
MSFC subcategories
12 months
Disability progressionWalking and mobilityExpanded Disability Status Scale (EDSS)
12 months
Disability progressionMFSC subcategories
12 months
Disability progressionThinking and memory
Who could take part
Progressive MS · 18 to 60
Inclusion Criteria: 1. 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. 2. Patients with EDSS score in the range of 2 to 6.5, inclusive 3. EDSS progression ≥ 1 point within 2 years before inclusion Exclusion Criteria: 1. Disease other than MS responsible for clinical signs and/or MRI lesions 2. Secondary progressive MS with relapse in the 2 years before inclusion 3. Treatment with interferon or glatiramer acetate within four weeks prior to treatment allocation 4. Treatment with oral or systemic corticosteroids or ACTH within four weeks prior to treatment allocation. 5. Active current bacterial, viral (including hepatitis B and C, HIV, EBV, CMV, herpes zoster, herpes simplex), fungal, mycobacterium, protozoan, or other infection
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Results
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.This positive, albeit non-statistically significant response was observed as early as month-3 and sustained through to month-18, with similar trends seen in the PPMS and rfSPMS subpopulations.
Read by software from the paper's abstract
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History
Started
Jun 2005
Main results due
Jul 2007
Finished
Jan 2010
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