NCT06527222

A Study of Ranolazine in ALS

Ranolazine in ALS: Safety, and Effect on Cramps, Function and Quality of Life.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Swathy Chandrashekhar, MBBS · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate safety, effect on cramps, function and quality of life of ranolazine versus placebo for the treatment of ALS.

Detailed description

A prospective, multi center, double-blind, placebo-controlled, parallel group study of 2 doses of ranolazine (500 mg and 1000 mg twice daily) compared to placebo in patients with ALS. Approximately 72 adults with ALS will be enrolled into the study in the United States at approximately 7 ALS treatment sites. Participants will take oral ranolazine or placebo twice daily, attend a minimum of 5 onsite research visits, and 4 remote research visits. The study is estimated to last 28 weeks for each participant.

Conditions

• Amyotrophic Lateral Sclerosis

Interventions

Type	Name	Description
DRUG	Ranolazine	500mg twice daily
DRUG	Ranolazine	1000 mg twice daily
DRUG	Placebo	Ranolazine placebo twice daily

Timeline

• Start date: 2025-04-29
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2024-07-30
• Last updated: 2025-10-28

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study