A Study of Ranolazine in ALS
ConditionAmyotrophic Lateral Sclerosis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSwathy Chandrashekhar, MBBS
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Ranolazine
- Ranolazine
- Placebo
Treatment groups
72 Participants
are divided into 3 treatment groupsSponsors and collaborators
Swathy Chandrashekhar, MBBS
Lead sponsor
University of California, San Francisco
Sponsor institution
ALS Association
Collaborator
Source ClinicalTrials.gov