RecruitingPhase 2NCT06527222
A Study of Ranolazine in ALS
Ranolazine in ALS: Safety, and Effect on Cramps, Function and Quality of Life.
Sponsor
Swathy Chandrashekhar, MBBS
Enrollment
72 participants
Start Date
Apr 29, 2025
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria6
- 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 Criteria8
- 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.
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Interventions
DRUGRanolazine
500mg twice daily
DRUGRanolazine
1000 mg twice daily
DRUGPlacebo
Ranolazine placebo twice daily
Locations(7)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06527222
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