A Study of Ranolazine for ALS
This study is looking at ranolazine, a medication, to see if it is safe and helps with muscle cramps, daily function, and quality of life for people with Amyotrophic Lateral Sclerosis (ALS). You might be able to join if you are 18 or older, have a diagnosis of ALS, and your breathing assessment (forced vital capacity or FVC) is at least 50%. You also need to be able to swallow pills. The study will compare two different doses of ranolazine (500mg or 1000mg, both taken twice daily) to a placebo (an inactive pill that looks like the study drug). Researchers will be looking at how often side effects occur, how well people tolerate the treatment, and how often muscle cramps happen over about 28 weeks. The current recruitment status is unclear.
- Study design
- This is a multi-center, double-blind, placebo-controlled study involving about 72 adults with ALS. Participants will be randomly assigned to receive either ranolazine or a placebo.
- What's involved
- You would take ranolazine or placebo twice daily for approximately 28 weeks. You would also attend a minimum of 5 in-person research visits and 4 remote research visits.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcomes, such as side effect frequency and muscle cramp frequency, will be measured for up to 28 weeks.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study of Ranolazine in ALS
At a glance
Conditions
NCT06527222
Where you'd take part
This study runs at 6 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Mayo Clinic Florida
Jacksonville, Floridastudy coordinator listed
Recruiting
The Ohio State University
Columbus, Ohiostudy coordinator listed
Recruiting
University of California, San Francisco
San Francisco, Californiastudy coordinator listed
Recruiting
University of Kansas Medical Center
Fairway, Kansasstudy coordinator listed
Recruiting
University of Kansas Medical Center: Wichita
Wichita, Kansasstudy coordinator listed
Recruiting
University of Missouri Health Care
Columbia, Missouristudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Jeffrey Statland, MD · PRINCIPAL_INVESTIGATOR · University of Kansas Medical Center
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Want this trial checked against your situation?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Inclusion
Exclusion
What this trial measures
- Frequency of Treatment-Emergent Adverse EventsUp to 28 weeks
Patient report and medical records will be used to document adverse events and severe adverse events. Adverse events and severe adverse events will be assessed by the investigator and reported as needed for safety.
- Tolerability of treatment assignmentUp to 28 weeks
Tolerability will be measured by percentage of patients who complete the treatment assignment. Dose limiting toxicities will be determined by individual with an adverse event necessitating stopping.
- Muscle cramp frequencyUp to 28 weeks
Muscle cramp frequency will be measured numerically with a reporting period of 7 days. Changes will be compared from baseline to week 28 utilizing a modified Qualitative, Patient-Centered Assessment of Muscle Cramp Impact and Severity questionnaire.
- Muscle cramp severityUp to 28 weeks
Muscle cramp severity will be measured by a score of 1-10 (1 being a very mild muscle cramp and 10 being the most severe cramp you ever experienced). Changes will be compared from baseline to week 28 utilizing a modified Qualitative, Patient-Centered Assessment of Muscle Cramp Impact and Severity questionnaire.
- Muscle cramps impact on quality of lifeUp to 28 weeks
Effect of muscle cramps on quality of life will be measured with three patient reported yes or no questions (Yes indicating an impact on quality of life or no indicating no impact on quality of life). Changes will be compared from baseline to week 28 utilizing a modified Qualitative, Patient-Centered Assessment of Muscle Cramp Impact and Severity questionnaire
- Safety Lab Cystatin CUp to 28 weeks
Patient safety measured with lab value Cystatin C in mg/L.
- Safety Lab Estimated Glomerular Filtration Rate (eGFR)Up to 28 weeks
Patient safety measured with lab value eGFR in mL/min/1.73.
- Safety Lab Alanine Transaminase (ALT)Up to 28 weeks
Patient safety measured with lab value ALT in IU/L.
- Safety Lab Aspartate Transferase (AST)Up to 28 weeks
Patient safety measured with lab value AST in IU/L.
- Safety Lab Alkaline Phosphatase (ALP)Up to 28 weeks
Patient safety measured with lab value ALP in IU/L.
- Safety Lab Total BilirubinUp to 28 weeks
Patient safety measured with lab value total bilirubin in mg/dL.