Long-term survival analysis of masitinib in amyotrophic lateral sclerosis.

ABSTRACT:

Background

A randomized, placebo-controlled phase III study (AB10015) previously demonstrated that orally administered masitinib (4.5 mg/kg/day) slowed rate of functional decline, with acceptable safety, in amyotrophic lateral sclerosis (ALS) patients having an ALS Functional Rating Scale-revised (ALSFRS-R) progression rate from disease onset to baseline of <1.1 points/month. Here we assess long-term overall survival (OS) data of all participants from study AB10015 and test whether a signal in OS is evident in an enriched patient population similar to that prospectively defined for confirmatory study AB19001.

Methods

Survival status of all patients originally randomized in AB10015 was collected from participating investigational sites. Survival analysis (using the multivaria

SUBMITTER: Mora JS 

PROVIDER: S-EPMC8388186 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature