Actively Recruiting
A Study of Ranolazine in ALS
Led by Swathy Chandrashekhar, MBBS · Updated on 2025-10-28
72
Participants Needed
7
Research Sites
52 weeks
Total Duration
On this page
Sponsors
S
Swathy Chandrashekhar, MBBS
Lead Sponsor
A
ALS Association
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official 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 per revised El Escorial criteria
- Forced vital capacity (FVC) greater than or equal to 50%
- Able to swallow pills at the start of the study and expected to continue for the study duration
- If taking ALS modifying medications, on a stable dose for at least 30 days
- 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
- Using tracheostomy invasive ventilation or noninvasive ventilation more than 12 hours/day
- Pregnant or lactating women, adults unable to consent, and prisoners
- Taking ranolazine or any investigational drug within 30 days or 5 half-lives before screening
- Medically uncontrolled heart, liver, or kidney disease
- Baseline QTc interval prolongation over 450 ms for men or 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 dose of medications for muscle cramps for at least 30 days or have not been off these medications for at least 30 days prior to randomization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 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
7
National Neuromuscular Research Institute, PLLC.
Austin, Texas, United States, 78759
Not Yet Recruiting
Research Team
K
Katie Lillig, BS
CONTACT
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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