Recruiting
Phase 2

Ranolazine

Sponsor:

Swathy Chandrashekhar, MBBS

Code:

NCT06527222

Conditions

Amyotrophic Lateral Sclerosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ranolazine

Ranolazine

Placebo

Study Details

Brief 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.

Conditions

Amyotrophic Lateral Sclerosis

Study ID

NCT06527222

Start date

Apr 29, 2025

Status verified date

Jun, 2026

Completion date

Jul, 2028

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

72 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Ranolazine low dose

Participants receive Ranolazine 500mg orally twice daily for 24 weeks.

experimental: Ranolazine high dose

Participants receive Ranolazine 1000mg orally twice daily for 24 weeks.

placebo comparator: Placebo

Participants receive Ranolazine placebo orally twice daily for 24 weeks.

Interventions

Ranolazine

500mg twice daily

Ranolazine

1000 mg twice daily

Placebo

Ranolazine placebo twice daily

Primary outcome measure

  • Frequency of Treatment-Emergent Adverse Events [ Time Frame: Up to 28 weeks ]
  • Tolerability of treatment assignment [ Time Frame: Up to 28 weeks ]
  • Muscle cramp frequency [ Time Frame: Up to 28 weeks ]
  • Muscle cramp severity [ Time Frame: Up to 28 weeks ]
  • Muscle cramps impact on quality of life [ Time Frame: Up to 28 weeks ]
  • Safety Lab Cystatin C [ Time Frame: Up to 28 weeks ]
  • Safety Lab Estimated Glomerular Filtration Rate (eGFR) [ Time Frame: Up to 28 weeks ]
  • Safety Lab Alanine Transaminase (ALT) [ Time Frame: Up to 28 weeks ]
  • Safety Lab Aspartate Transferase (AST) [ Time Frame: Up to 28 weeks ]
  • Safety Lab Alkaline Phosphatase (ALP) [ Time Frame: Up to 28 weeks ]
  • Safety Lab Total Bilirubin [ Time Frame: Up to 28 weeks ]

Central Contacts and Locations

Central contacts

Katie Lillig, BS

913-945-9932Kjennens2@kumc.edu

Locations

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Michael Han

415-353-7381Michael.Han@ucsf.edu

Neuromuscular.Research@ucsf.edu

Principal Investigator:

Swathy Chandrashekhar, MD

Mayo Clinic Florida

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Huy B. Tran

904-953-4503Tran.Huy1@mayo.edu

Principal Investigator:

Bjorn E Oskarsson, MD

University of Kansas Medical Center

Recruiting

Fairway, Kansas, United States, 66205

Contacts

Nick Staudenmier, BS

913-945-9922nstaudenmier@kumc.edu

Katie Lillig, BS

913-945-9932Kjennens2@kumc.edu

Principal Investigator:

Jeffrey Statland, MD

University of Kansas Medical Center: Wichita

Recruiting

Wichita, Kansas, United States, 67214

Contacts

KUMC CTSU Wichita

316-293-1833clinicaltrialunit@kumc.edu

Hannah Hancock

hhancock@kumc.edu

Principal Investigator:

Matthew Byerly, MD

University of Missouri Health Care

Recruiting

Columbia, Missouri, United States, 65212

Contacts

Amanda Heider

573-884-6852ahmc4@umsystem.edu

Principal Investigator:

William D Arnold, MD

The Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Atchayah Balakrishna

Atchayah.Balakrishna@osumc.edu

Kaneshia Hives

Kaneshia.Hives@osumc.edu

Principal Investigator:

Sarah Heintzman, CNP

More Information

Sponsor

Swathy Chandrashekhar, MBBS

Last update posted

Jun 8, 2026

Last verified

Jun, 2026

Keywords

  • ALS
  • Motor Neuron Disease
  • Lou Gehrig's Disease
  • Placebo-Controlled

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Swathy Chandrashekhar, MBBS on 2026-06-08.