NCT06527222ClinicalTrials.gov
A Study of Ranolazine in ALS
Ranolazine in ALS: Safety, and Effect on Cramps, Function and Quality of Life.
In brief
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.
Phase 272 participants sought6 sites1 country
Categories
Registered in 1 registry
- ClinicalTrials.govNCT06527222Open this record at ClinicalTrials.govSynced 2 months ago
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Trial information is shown as published by the registry, in its original language.
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How this study is set up
The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.
- Present: Registered before enrolment beganFirst posted 2024-07-30; recorded start 2025-04-29
- Present: Has a defined primary outcomeA primary outcome measure is listed in the record
- Present: The primary outcome states a time frameThe primary outcome measure records a time frame
- Present: Participants are randomly assignedAllocation is recorded as randomised
- Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
- Present: Uses blinding (masking)A masking level is recorded in the record
- Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
- Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
- Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
- Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
- Not stated: No other studies from this sponsor are in this databaseCounted from the lead sponsor named in the record (Swathy Chandrashekhar, MBBS)
- Not stated: No posted results from this sponsor are in this database yetBased on the sponsor’s studies in this database
- The record lists 1 condition.
- Lead sponsor type recorded as: other.
- Intervention regulatory context: investigational, within a phased regulatory pathway.
Trial stature
Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.
A definitive-grade design for a phase 2 study, judged from its ClinicalTrials.gov record.
How this score is built
- Randomised allocation20/20
Participants are randomly allocated between arms
- Blinding20/20
Quadruple-blind
- Control arm13/15
Placebo / sham control arm
- Primary-outcome specificity10/10
Named primary outcome with a defined time frame
- Endpoint type3/10
Surrogate or intermediate endpoint (conservative default)
- Multi-centre5/8
Multi-centre: 6 sites
- Data monitoring committee7/7
A data monitoring committee is in place
- Prospective registration5/5
Registered before the study start date
- Protocol / SAP posted0/5
No protocol or SAP posted to the registry
A small study: 72 participants (target), run at 6 sites.
How this score is built
- Enrolment17/40
72 participants (target)
- Site count9/25
6 sites
- Country count0/15
Single country
- Planned duration8/10
Planned over about 39 months
- Sponsor scale0/10
Swathy Chandrashekhar, MBBS has led 1 trials in our corpus
We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.
How this score is built
- Investigator standing0/100
No investigator recorded in the registry for this trial
These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.
Summary
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.
Conditions
- Amyotrophic Lateral Sclerosis
Eligibility
| Sex | All |
|---|---|
| Ages | 18 Years – No maximum |
| Healthy volunteers | No |
Eligibility as written in the registry
Eligibility in plain statements
This record's criteria have not been broken into separate statements yet. The registry text above is complete and is the authoritative version.
Study design
| Study type | Interventional |
|---|---|
| Phase | Phase 2 |
| Allocation | Randomised |
| Intervention model | PARALLEL |
| Primary purpose | TREATMENT |
| Masking | QUADRUPLE (4) |
| Enrolment | 72 participants sought |
Sponsor and collaborators
- Swathy Chandrashekhar, MBBS Sponsor
- ALS Association Collaborators
Arms and interventions
- Ranolazine low doseEXPERIMENTAL
Participants receive Ranolazine 500mg orally twice daily for 24 weeks.
- Ranolazine high doseEXPERIMENTAL
Participants receive Ranolazine 1000mg orally twice daily for 24 weeks.
- PlaceboPLACEBO_COMPARATOR
Participants receive Ranolazine placebo orally twice daily for 24 weeks.
Interventions
- Drug Placebo
Ranolazine placebo twice daily
- Drug Ranolazine
500mg twice daily
- Drug Ranolazine
1000 mg twice daily
Outcome measures
Primary outcome
Frequency of Treatment-Emergent Adverse Events
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.
Time frame Up to 28 weeks
Primary outcome
Tolerability of treatment assignment
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.
Time frame Up to 28 weeks
Primary outcome
Muscle cramp frequency
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.
Time frame Up to 28 weeks
Primary outcome
Muscle cramp severity
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.
Time frame Up to 28 weeks
Primary outcome
Muscle cramps impact on quality of life
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
Time frame Up to 28 weeks
Primary outcome
Safety Lab Cystatin C
Patient safety measured with lab value Cystatin C in mg/L.
Time frame Up to 28 weeks
Primary outcome
Safety Lab Estimated Glomerular Filtration Rate (eGFR)
Patient safety measured with lab value eGFR in mL/min/1.73.
Time frame Up to 28 weeks
Primary outcome
Safety Lab Alanine Transaminase (ALT)
Patient safety measured with lab value ALT in IU/L.
Time frame Up to 28 weeks
Primary outcome
Safety Lab Aspartate Transferase (AST)
Patient safety measured with lab value AST in IU/L.
Time frame Up to 28 weeks
Primary outcome
Safety Lab Alkaline Phosphatase (ALP)
Patient safety measured with lab value ALP in IU/L.
Time frame Up to 28 weeks
Primary outcome
Safety Lab Total Bilirubin
Patient safety measured with lab value total bilirubin in mg/dL.
Time frame Up to 28 weeks
Secondary outcome
Muscle strength
Change in muscle strength over time as measured by hand grip and hand-held dynamometry (HHD) in pounds.
Time frame Up to 28 weeks
Secondary outcome
ALS Functional Rating Scale-Revised (ALSFRS-R)
Change in disease severity over time as measured by the ALS Functional Rating Scale-Revised (ALSFRS-R). Each type of function is scored from 4 (normal) to 0 (no ability), with a maximum total score of 48 and a minimum total score of 0. Patients with higher scores have more physical function.
Time frame Up to 28 weeks
Secondary outcome
Forced Vital Capacity (FVC)
Change in respiratory function as measured by Forced Vital Capacity (FVC) in liters.
Time frame Up to 28 weeks
Secondary outcome
Serum neurofilament light
Changes in serum neurofilament light measured from baseline to end of treatment assignment. Data will be collected to determine differences between placebo and Ranolazine treatment groups at completion of the study.
Time frame Up to 28 weeks
Secondary outcome
Lymphocyte Mitochondrial Function
Change in mitochondrial function in lymphocytes measured from baseline to the end of treatment assignment. Data will be collected to determine differences between placebo and Ranolazine treatment groups at completion of the study
Time frame Up to 28 weeks
Dates
| Start date | April 29, 2025 (actual) |
|---|---|
| Primary completion | July 1, 2028 (estimated) |
| Completion | July 1, 2028 (estimated) |
| First posted | July 30, 2024 (actual) |
| Last updated | June 8, 2026 |
| Results posted | Not stated in the registry record |
| Status last verified | June 2026 |
Actual means the event happened. Estimated means the sponsor expects it. The two mean different things.
Locations
6 sites are recruiting
United States
| Facility | City | State or region | Status |
|---|---|---|---|
| University of Missouri Health Care | Columbia | Missouri | Recruiting |
| The Ohio State University | Columbus | Ohio | Recruiting |
| University of Kansas Medical Center | Fairway | Kansas | Recruiting |
| Mayo Clinic Florida | Jacksonville | Florida | Recruiting |
| University of California, San Francisco | San Francisco | California | Recruiting |
| University of Kansas Medical Center: Wichita | Wichita | Kansas | Recruiting |
Study documents
No documents are linked in this registry record.
Changes over time
No changes have been recorded since we first ingested this record.
A change is recorded each time the sponsor updates the registry record. Status, dates, enrolment and sites appear here as they move.