A Study of Ranolazine in ALS

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.

Conditions

Amyotrophic Lateral Sclerosis

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Study Overview

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Study Details

Study overview

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.

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

A Study of Ranolazine in ALS

Condition
Amyotrophic Lateral Sclerosis
Intervention / Treatment

-

Contacts and Locations

San Francisco

University of California, San Francisco, San Francisco, California, United States, 94143

Jacksonville

Mayo Clinic Florida, Jacksonville, Florida, United States, 32224

Fairway

University of Kansas Medical Center, Fairway, Kansas, United States, 66205

Wichita

University of Kansas Medical Center: Wichita, Wichita, Kansas, United States, 67214

Columbia

University of Missouri Health Care, Columbia, Missouri, United States, 65212

Columbus

The Ohio State University, Columbus, Ohio, United States, 43210

Milwaukee

The Medical College of Wisconsin, Milwaukee, Wisconsin, United States, 53226

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Swathy Chandrashekhar, MD,

Jeffrey Statland, MD, PRINCIPAL_INVESTIGATOR, University of Kansas Medical Center

Study Record Dates

2026-12