Randomized phase 2 study of perampanel for sporadic amyotrophic lateral sclerosis.

ABSTRACT:

Objective

To evaluate the efficacy and safety of perampanel in patients with sporadic amyotrophic lateral sclerosis (SALS).

Methods

This randomized, double-blind, placebo-controlled, multicenter, phase 2 clinical study was conducted at 12 sites. Patients with probable or definite ALS as defined by revised El Escorial criteria were enrolled. Sixty-six patients were randomly assigned (1:1:1) to receive placebo, 4 mg perampanel, or 8 mg perampanel daily for 48 weeks. Adverse events (AEs) were recorded throughout the trial period. The primary efficacy outcome was the change in Amyotrophic Lateral Sclerosis Rating Scale-Revised (ALSFRS-R) score after 48 weeks of treatment.

Results

One patient withdrew before starting the treatment. Of 65 patients included, 18 of 22 patient

SUBMITTER: Aizawa H 

PROVIDER: S-EPMC8782807 | biostudies-literature | 2022 Feb

REPOSITORIES: biostudies-literature