Status:
RECRUITING
A Study of Ranolazine in ALS
Lead Sponsor:
Swathy Chandrashekhar, MBBS
Collaborating Sponsors:
ALS Association
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Detailed 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 7...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 29 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT06527222
Start Date
April 29 2025
End Date
May 1 2026
Last Update
October 28 2025
Active Locations (7)
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1
University of California, San Francisco
San Francisco, California, United States, 94143
2
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
3
University of Kansas Medical Center
Fairway, Kansas, United States, 66205
4
University of Kansas Medical Center: Wichita
Wichita, Kansas, United States, 67214