Evaluating ranolazine for treating ALS symptoms
Official title: Ranolazine in ALS: Safety, and Effect on Cramps, Function and Quality of Life.
Run by University of California, San Francisco · NCT06527222 · Data updated 2026-11-12
This study is testing if the medication ranolazine can help improve muscle cramps and quality of life for people with ALS.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 72 (estimated) |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 6 sites (San Francisco, California and 5 other locations) |
| Status | Recruiting |
| Started | April 29, 2025 |
| Main results expected | July 2028 |
| Study ends | July 2028 |
| Registry record updated | June 8, 2026 |
| Trial ID | NCT06527222 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 and older who have been diagnosed with ALS and experience frequent muscle cramps.
✕Probably not a fit
Patients with a disease duration of less than 5 years or those requiring extensive respiratory support may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the safety and efficacy of ranolazine in treating symptoms of Amyotrophic Lateral Sclerosis (ALS), specifically focusing on muscle cramps, functional ability, and quality of life. It is a multi-center, double-blind, placebo-controlled trial involving two doses of ranolazine administered twice daily to participants. Approximately 72 adults diagnosed with ALS will be enrolled across seven treatment sites in the United States, with participants required to attend both onsite and remote research visits over a period of 28 weeks.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option to alleviate muscle cramps and improve quality of life for ALS patients.
How similar studies have gone: While there have been various studies on ALS treatments, the specific use of ranolazine for this purpose is novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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's running
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University of California, San Francisco
San Francisco, California, United States Recruiting -
Mayo Clinic Florida
Jacksonville, Florida, United States Recruiting -
University of Kansas Medical Center
Fairway, Kansas, United States Recruiting -
University of Kansas Medical Center: Wichita
Wichita, Kansas, United States Recruiting -
University of Missouri Health Care
Columbia, Missouri, United States Recruiting -
The Ohio State University
Columbus, Ohio, United States Recruiting
Study contacts
- Principal investigator: Jeffrey Statland, MD — University of Kansas Medical Center
- Study coordinator: Katie Lillig, BS
- Email: Kjennens2@kumc.edu
- Phone: 913-945-9932
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.