Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
72 participants
INTERVENTIONAL
2025-04-29
2026-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Ranolazine low dose
Participants receive Ranolazine 500mg orally twice daily for 24 weeks.
Ranolazine
500mg twice daily
Ranolazine high dose
Participants receive Ranolazine 1000mg orally twice daily for 24 weeks.
Ranolazine
1000 mg twice daily
Placebo
Participants receive Ranolazine placebo orally twice daily for 24 weeks.
Placebo
Ranolazine placebo twice daily
Interventions
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Ranolazine
500mg twice daily
Ranolazine
1000 mg twice daily
Placebo
Ranolazine placebo twice daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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ALS Association
OTHER
Swathy Chandrashekhar, MBBS
OTHER
Responsible Party
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Swathy Chandrashekhar, MBBS
Principal Investigator
Principal Investigators
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Jeffrey Statland, MD
Role: PRINCIPAL_INVESTIGATOR
University of Kansas Medical Center
Locations
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University of California, San Francisco
San Francisco, California, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
University of Kansas Medical Center
Fairway, Kansas, United States
University of Kansas Medical Center: Wichita
Wichita, Kansas, United States
University of Missouri Health Care
Columbia, Missouri, United States
The Ohio State University
Columbus, Ohio, United States
National Neuromuscular Research Institute, PLLC.
Austin, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Role: backup
Other Identifiers
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24-43175
Identifier Type: -
Identifier Source: org_study_id
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