NCT06527222 · Swathy Chandrashekhar, MBBS
A Study of Ranolazine in ALS
What this study is about
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.
View original scientific description
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.
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
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 assignment
Time frame: Up 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 frequency
Time frame: Up 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 severity
Time frame: Up 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 life
Time frame: Up 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 C
Time frame: Up to 28 weeks
Patient safety measured with lab value Cystatin C in mg/L.
Safety Lab Estimated Glomerular Filtration Rate (eGFR)
Time frame: Up to 28 weeks
Patient safety measured with lab value eGFR in mL/min/1.73.
Safety Lab Alanine Transaminase (ALT)
Time frame: Up to 28 weeks
Patient safety measured with lab value ALT in IU/L.
Safety Lab Aspartate Transferase (AST)
Time frame: Up to 28 weeks
Patient safety measured with lab value AST in IU/L.
Safety Lab Alkaline Phosphatase (ALP)
Time frame: Up to 28 weeks
Patient safety measured with lab value ALP in IU/L.
Safety Lab Total Bilirubin
Time frame: Up to 28 weeks
Patient safety measured with lab value total bilirubin in mg/dL.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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/ \>47
Where
- San Francisco, California
- Jacksonville, Florida
- Fairway, Kansas
- Wichita, Kansas
- Columbia, Missouri
- Columbus, Ohio
Collaborators
ALS Association
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 8, 2026 · Source of record for eligibility and locations