A Study of Ranolazine in ALS
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ranolazine, Ranolazine, Placebo.
- Who it may be relevant to
- Registry conditions: Amyotrophic Lateral Sclerosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Ranolazine in ALS: Safety, and Effect on Cramps, Function and Quality of Life.
Overview
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 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.
Interventions
- Drug Ranolazine
500mg twice daily - Drug Ranolazine
1000 mg twice daily - Drug Placebo
Ranolazine placebo twice daily
Primary outcome measures
- Frequency of Treatment-Emergent Adverse Events [Time frame: Up to 28 weeks]
- Tolerability of treatment assignment [Time frame: Up to 28 weeks]
- Muscle cramp frequency [Time frame: Up to 28 weeks]
- Muscle cramp severity [Time frame: Up to 28 weeks]
- Muscle cramps impact on quality of life [Time frame: Up to 28 weeks]
- Safety Lab Cystatin C [Time frame: Up to 28 weeks]
- Safety Lab Estimated Glomerular Filtration Rate (eGFR) [Time frame: Up to 28 weeks]
- Safety Lab Alanine Transaminase (ALT) [Time frame: Up to 28 weeks]
- Safety Lab Aspartate Transferase (AST) [Time frame: Up to 28 weeks]
- Safety Lab Alkaline Phosphatase (ALP) [Time frame: Up to 28 weeks]
Secondary outcome measures (5)
- Muscle strength [Time frame: Up to 28 weeks]
- ALS Functional Rating Scale-Revised (ALSFRS-R) [Time frame: Up to 28 weeks]
- Forced Vital Capacity (FVC) [Time frame: Up to 28 weeks]
- Serum neurofilament light [Time frame: Up to 28 weeks]
- Lymphocyte Mitochondrial Function [Time frame: Up to 28 weeks]
Eligibility criteria
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 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 6 centers
- University of California, San Francisco — San Francisco
- Mayo Clinic Florida — Jacksonville
- University of Kansas Medical Center — Fairway
- University of Kansas Medical Center: Wichita — Wichita
- University of Missouri Health Care — Columbia
- The Ohio State University — Columbus
Identifiers
NCT: NCT06527222 · 24-43175