Ranolazine in ALS: Safety, and Effect on Cramps, Function and Quality of Life.
Swathy Chandrashekhar, MBBS
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.
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 72 adults with ALS will be enrolled into the study in the United States at approximately 7 ALS treatment sites. Participants will take oral ranolazine or placebo twice daily, attend a minimum of 5 onsite research visits, and 4 remote research visits. The study is estimated to last 28 weeks for each participant.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugRanolazine
500mg twice daily
- DrugRanolazine
1000 mg twice daily
- DrugPlacebo
Ranolazine placebo twice daily
Locations (7)
- University of California, San FranciscoSan Francisco, California
- Mayo Clinic FloridaJacksonville, Florida
- University of Kansas Medical CenterFairway, Kansas
- University of Kansas Medical Center: WichitaWichita, Kansas
- University of Missouri Health CareColumbia, Missouri
- The Ohio State UniversityColumbus, Ohio