Actively Recruiting
Ranolazine in ALS: Safety and Effects on Muscle Cramps, Function, and Quality of Life
Led by Swathy Chandrashekhar, MBBS · Updated on 2026-06-08
72
Participants Needed
6
Research Sites
N/A
Total Duration
On this page
Sponsors
S
Swathy Chandrashekhar, MBBS
Lead Sponsor
A
ALS Association
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the safety and effects of ranolazine compared to a placebo in adults with amyotrophic lateral sclerosis (ALS). The study focuses on how ranolazine impacts muscle cramps, muscle function, and quality of life. This is a phase 2, multi-center, double-blind trial involving approximately 72 participants across several ALS treatment centers in the United States. Participants will be randomly assigned to one of three groups: low-dose ranolazine (500 mg twice daily), high-dose ranolazine (1000 mg twice daily), or placebo taken twice daily. Treatment lasts for 24 weeks, during which participants will attend at least five in-person visits and four remote visits. The trial includes ongoing monitoring for safety and treatment effects throughout the 28-week study period. During the study, participants will have regular assessments including muscle cramp frequency and severity, muscle strength, breathing tests such as forced vital capacity, and quality of life questionnaires. Blood tests will monitor kidney and liver function and other safety labs. Researchers will also measure ALS functional rating scores and specific biomarkers. The total participation time for each person is about 28 weeks, with continuous evaluation of treatment tolerability and adverse events.
CONDITIONS
Brief Title
A Study of Ranolazine in ALS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years or older
- Diagnosed with clinically definite, possible, probable, or lab-supported probable ALS according to revised El Escorial criteria
- Forced vital capacity (FVC) of 50% or greater
- Able to swallow pills at the start and expected to throughout the study
- On stable doses of ALS modifying medications for at least 30 days if applicable
- Experiencing 4 or more muscle cramps per week during a 2-week screening period
You will not qualify if you...
- Disease duration less than 5 years
- Use of tracheostomy invasive ventilation or noninvasive ventilation more than 12 hours per day
- Pregnant or lactating individuals, adults unable to consent, or prisoners
- Currently taking ranolazine or any investigational drug, or received one within 30 days prior to screening
- Medically uncontrolled heart, liver, or kidney disease
- Baseline QTc interval prolongation over 450 ms for men or over 470 ms for women, history of long QT syndrome, or use of medications that prolong QT interval
- Participation in another experimental drug trial within 30 days before screening
- Not on a stable dosage of medications used to treat muscle cramps for at least 30 days or have been off such medications for at least 30 days prior to randomization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 24 weeks
Participants take oral ranolazine or placebo twice daily and attend research visits for treatment monitoring.
At least 5 onsite visits and 4 remote visits
Duration - Up to 4 weeks
Participants are monitored for safety and effects on muscle cramps, function, and quality of life after treatment.
Ongoing assessments during the study period up to 28 weeks
Trial Site Locations
Total: 6 locations
1
University of California, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
2
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
Actively Recruiting
3
University of Kansas Medical Center
Fairway, Kansas, United States, 66205
Actively Recruiting
4
University of Kansas Medical Center: Wichita
Wichita, Kansas, United States, 67214
Actively Recruiting
5
University of Missouri Health Care
Columbia, Missouri, United States, 65212
Actively Recruiting
6
The Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
K
Katie Lillig, BS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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