A Study of Ranolazine in ALS

Last updated: April 14, 2025
Sponsor: Swathy Chandrashekhar, MD
Overall Status: Active - Recruiting

Phase

2

Condition

Amyotrophic Lateral Sclerosis (Als)

Myasthenia Gravis (Chronic Weakness)

Treatment

Placebo

Ranolazine

Clinical Study ID

NCT06527222
STUDY00160072
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 18 years or older

  • Diagnosed with clinically definite, possible, probably, or lab-supported probableALS 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 ofthe 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

Exclusion Criteria:

  • Disease duration < 5 years

  • Tracheostomy invasive ventilation, or noninvasive ventilation of more than 12hours/day

  • Pregnant or lactating, adults unable to consent, and prisoners

  • Taking ranolazine or investigational drug or has received an investigational drugwithin 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 oflong 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 musclecramps for ≥30 days or have been off these medications ≥30 days prior torandomization.

Study Design

Total Participants: 72
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
April 01, 2025
Estimated Completion Date:
December 31, 2026

Study Description

A prospective, multi center, double-blind, placebo-controlled, parallel group study of 2 doses of ranolazine (500 mg and 1000 mg twice daily) compared to placebo in patients with ALS.

Approximately 72 adults with ALS will be enrolled into the study in the United States at approximately 7 ALS treatment sites.

Participants will take oral ranolazine or placebo twice daily, attend a minimum of 5 onsite research visits, and 4 remote research visits.

The study is estimated to last 28 weeks for each participant.

Connect with a study center

  • University of California, San Francisco

    San Francisco, California 94143
    United States

    Site Not Available

  • Mayo Clinic Florida

    Jacksonville, Florida 32224
    United States

    Active - Recruiting

  • University of Kansas Medical Center

    Fairway, Kansas 66205
    United States

    Active - Recruiting

  • University of Kansas Medical Center: Wichita

    Wichita, Kansas 67214
    United States

    Site Not Available

  • University of Missouri Health Care

    Columbia, Missouri 65212
    United States

    Active - Recruiting

  • The Ohio State University

    Columbus, Ohio 43210
    United States

    Site Not Available

  • The Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.