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A Study of Ranolazine in ALS

RecruitingPhase 2

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

Who can join

Ages 18 and older · All sexes

Full eligibility 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.

About the study

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.

What is being tested

Sponsor: Swathy Chandrashekhar, MBBS · Participants: 72 · Started: Apr 29, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06527222

Locations in the U.S.

CaliforniaUniversity of California, San Francisco, San Francisco
FloridaMayo Clinic Florida, Jacksonville
KansasUniversity of Kansas Medical Center, Fairway
University of Kansas Medical Center: Wichita, Wichita
MissouriUniversity of Missouri Health Care, Columbia
OhioThe Ohio State University, Columbus

Conditions

From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.