A Study of Ranolazine in ALS

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Amyotrophic Lateral Sclerosis

In brief

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.

Key facts

Study ID

NCT06527222

Run by

Swathy Chandrashekhar, MBBS

People needed

72

Starts

2025-04-29

Expected to finish

2028-07-01

Last updated by the study team

2026-06-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 years or older
• Diagnosed with clinically definite, possible, probably, or lab-supported probable ALS per revised El Escorial criteria
• Breathing assessment called forced vital capacity (FVC) greater than or equal to 50%.
• Able to swallow pills at the start of the study and expected to for the length of the study.
• If on ALS modifying medications must be on a stable dose at least 30 days.
• Experiencing 4 or more cramps per week during a 2-week screening period.

You may not qualify if…

• Disease duration < 5 years
• Tracheostomy invasive ventilation, or noninvasive ventilation of more than 12 hours/day
• Pregnant or lactating, adults unable to consent, and prisoners
• Taking ranolazine or investigational drug or has received an investigational drug within 30 days (or 5 half-lives for drugs, whichever is longer) prior to screening
• Medically uncontrolled comorbidities (heart, liver, kidney disease)
• Baseline QTc interval prolongation >450 ms for men/ >470 ms for women, history of long QT syndrome, or medications which prolong the QT interval
• Participation in an experimental drug trial less than 30 days before screening
• Patients have to be on a stable dosage of any medications used to treat muscle cramps for ≥30 days or have been off these medications ≥30 days prior to randomization.

Where it is running

• University of California, San Francisco — San Francisco, California, United States (enrolling)
• Mayo Clinic Florida — Jacksonville, Florida, United States (enrolling)
• University of Kansas Medical Center — Fairway, Kansas, United States (enrolling)
• University of Kansas Medical Center: Wichita — Wichita, Kansas, United States (enrolling)
• University of Missouri Health Care — Columbia, Missouri, United States (enrolling)
• The Ohio State University — Columbus, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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