Efficacy and Safety of Masitinib in the Treatment of Progressive Multiple Sclerosis
What it found
The main measure showed a statistically significant benefit.
“Masitinib (4.5 mg/kg/d) (n = 199) showed significant benefit over placebo (n = 101) according to the primary end point, 0.001 vs 0.098, respectively, with a between-group difference of -0.097 (97% CI -0.192 to -0.002); p = 0.0256.”Read by software from the paper's abstract
96 weeks
| Group | n | Value |
|---|---|---|
| Masitinib 4.5 mg/kg/d | 199 | 0.001 |
| Placebo | 101 | 0.098 |
mean difference -0.097 (95% CI -0.192–-0.002)
p = 0.0256
Total participants: 611
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
Placebo or sham
- Placebo
What it measured
Main measures
EDSS
96 weeks
Disability progression
Other measures (2)
MSQOL-54
96 weeks
Quality of life (reported by participants)MSFC
96 weeks
Disability progression
Who could take part
Progressive MS · 18 to 75
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
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 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.
Papers
Results
Efficacy and Safety of Masitinib in Progressive Forms of Multiple Sclerosis: A Randomized, Phase 3, Clinical Trial.Neurol Neuroimmunol Neuroinflamm · 2022
Masitinib (4.5 mg/kg/d) (n = 199) showed significant benefit over placebo (n = 101) according to the primary end point, 0.001 vs 0.098, respectively, with a between-group difference of -0.097 (97% CI -0.192 to -0.002); p = 0.0256.
Read by software from the paper's abstract
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History
Started
Aug 2011
Main results due
Sept 2019
Finished
Feb 2020
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