Skip to main content
TrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor about whether a trial is right for you.
RECRUITINGPhase 2INTERVENTIONAL

A Study of Ranolazine in ALS

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

Ranolazine

500mg twice daily

DRUG

Ranolazine

1000 mg twice daily

DRUG

Placebo

Ranolazine placebo twice daily

Locations (7)

University of California, San Francisco
San Francisco, California, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
University of Kansas Medical Center
Fairway, Kansas, United States
University of Kansas Medical Center: Wichita
Wichita, Kansas, United States
University of Missouri Health Care
Columbia, Missouri, United States
The Ohio State University
Columbus, Ohio, United States
National Neuromuscular Research Institute, PLLC.
Austin, Texas, United States