Tests ranolazine against a placebo in people with ALS
Tests ranolazine versus a placebo in adults with ALS for safety and symptoms.
Plain-language title generated from the registry record
Registry title: A Study of Ranolazine in ALS
Key facts
- Where
- Columbia, Columbus, Fairway, Jacksonville, San Francisco, and Wichita, United StatesSee the 6 sites
- Phase
- Phase 2
Where in United States
- University of Missouri Health CareColumbia, United StatesTaking people
- The Ohio State UniversityColumbus, United StatesTaking people
- University of Kansas Medical CenterFairway, United StatesTaking people
- Mayo Clinic FloridaJacksonville, United StatesTaking people
- University of California San FranciscoSan Francisco, United StatesTaking people
- University of Kansas Medical Center: WichitaWichita, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Swathy Chandrashekhar, MBBS
- Trial code
- NCT06527222
- Record updated
- 8 June 2026
- Original description
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.Read full original descriptionShow less
Ranolazine in ALS: Safety, and Effect on Cramps, Function and Quality of Life.
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.
Inclusion: 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: 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; 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; 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; 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.