Study of Ranolazine to Assess Safety and Impact on Muscle Cramps, Function, and Quality of Life in Adults with ALS

What this Trial Is About

Researchers are studying the safety and effects of ranolazine compared to a placebo in adults with amyotrophic lateral sclerosis ALS. The study focuses on how ranolazine impacts muscle cramps, muscle function, and quality of life. This is a phase 2, multi-center, double-blind trial involving approximately 72 participants across several ALS treatment centers in the United States. Participants will be randomly assigned to one of three groups low-dose ranolazine 500 mg twice daily, high-dose ranolazine 1000 mg twice daily, or placebo taken twice daily. Treatment lasts for 24 weeks, during which participants will attend at least five in-person visits and four remote visits. The trial includes ongoing monitoring for safety and treatment effects throughout the 28-week study period. During the study, participants will have regular assessments including muscle cramp frequency and severity, muscle strength, breathing tests such as forced vital capacity, and quality of life questionnaires. Blood tests will monitor kidney and liver function and other safety labs. Researchers will also measure ALS functional rating scores and specific biomarkers. The total participation time for each person is about 28 weeks, with continuous evaluation of treatment tolerability and adverse events.

A Study of Ranolazine in ALS