Open-label pilot study of ranolazine for cramps in amyotrophic lateral sclerosis.

ABSTRACT:

Introduction/aims

Neuronal hyperexcitability (manifested by cramps) plays a pathological role in amyotrophic lateral sclerosis (ALS), and drugs affecting it may help symptomatic management and slow disease progression. We aimed to determine safety and tolerability of two doses of ranolazine in patients with ALS and evaluate for preliminary evidence of drug-target engagement by assessing muscle cramp characteristics.

Methods

We performed an open-label dose-ascending study of ranolazine in 14 individuals with ALS in two sequential cohorts: 500 mg (cohort 1) and 1000 mg (cohort 2) orally twice daily. Each had a 2-week run-in period, 4-week drug administration, and 6-week safety follow-up. Primary outcome was safety and tolerability. Exploratory measures included cramp frequency

SUBMITTER: Chandrashekhar S 

PROVIDER: S-EPMC9197965 | biostudies-literature | 2022 Jul

REPOSITORIES: biostudies-literature