Evaluación de masitinib en esclerosis múltiple
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 |
between-group 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
What it measured
Main measures
Variable principal:
Other measures (1)
Variables secundarias:
Who could take part
Progressive MS
Inclusion: 1. Paciente con sufre esclerosis múltiple primaria progresiva o secundaria progresiva sin recidivas en los 2 años previos a la inclusión, según los criterios de MacDonald revisados Exclusion: 1. Paciente que sufre una enfermedad distinta a la EM que explicaría mejor los síntomas y signos clínicos neurológicos del paciente y/o las lesiones de la RM
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
El objetivo es comparar la seguridad y la eficacia de masitinib a la dosis de 6 mg/kg/día con placebo en el tratamiento de pacientes con esclerosis múltiple primaria o esclerosis múltiple secundaria progresiva sin recidiva.
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
Jul 2011
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