NCT06527222ClinicalTrials.gov
A Study of Ranolazine in ALS
Ranolazine in ALS: Safety, and Effect on Cramps, Function and Quality of Life.
Kurz gefasst
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 Teilnehmende gesucht6 Studienzentren1 Land
Kategorien
In 1 Register registriert
- ClinicalTrials.govNCT06527222Diesen Eintrag bei ClinicalTrials.gov öffnenSynchronisiert vor 2 Monaten
Eine Studie kann in mehreren Registern registriert sein. Wir zeigen sie einmal und verlinken jeden Eintrag, den wir haben.
Die Studieninformationen werden so angezeigt, wie sie vom Register veröffentlicht wurden, in ihrer Originalsprache.
Interesse an dieser Studie?
Anmelden oder ein Konto erstellen um Ihr Interesse zu bekunden und diese Studie zu verfolgen.
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.
Zusammenfassung
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.
Erkrankungen
- Amyotrophic Lateral Sclerosis
Eignung
| Geschlecht | Alle |
|---|---|
| Alter | 18 Years – Kein Höchstalter |
| Gesunde Freiwillige | Nein |
Eignung im Wortlaut des Registers
Eignung in einfachen Aussagen
Die Kriterien dieses Eintrags wurden noch nicht in einzelne Aussagen aufgeschlüsselt. Der Registertext oben ist vollständig und ist die maßgebliche Fassung.
Studiendesign
| Studientyp | Interventionell |
|---|---|
| Phase | Phase 2 |
| Zuteilung | Randomisiert |
| Interventionsmodell | PARALLEL |
| Primäres Ziel | TREATMENT |
| Verblindung | QUADRUPLE (4) |
| Teilnahme | 72 Teilnehmende gesucht |
Sponsor und Mitwirkende
- Swathy Chandrashekhar, MBBS Sponsor
- ALS Association Mitwirkende
Studienarme und Interventionen
- 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.
Interventionen
- Arzneimittel Placebo
Ranolazine placebo twice daily
- Arzneimittel Ranolazine
500mg twice daily
- Arzneimittel Ranolazine
1000 mg twice daily
Endpunkte
Primärer Endpunkt
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.
Zeitrahmen Up to 28 weeks
Primärer Endpunkt
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.
Zeitrahmen Up to 28 weeks
Primärer Endpunkt
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.
Zeitrahmen Up to 28 weeks
Primärer Endpunkt
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.
Zeitrahmen Up to 28 weeks
Primärer Endpunkt
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
Zeitrahmen Up to 28 weeks
Primärer Endpunkt
Safety Lab Cystatin C
Patient safety measured with lab value Cystatin C in mg/L.
Zeitrahmen Up to 28 weeks
Primärer Endpunkt
Safety Lab Estimated Glomerular Filtration Rate (eGFR)
Patient safety measured with lab value eGFR in mL/min/1.73.
Zeitrahmen Up to 28 weeks
Primärer Endpunkt
Safety Lab Alanine Transaminase (ALT)
Patient safety measured with lab value ALT in IU/L.
Zeitrahmen Up to 28 weeks
Primärer Endpunkt
Safety Lab Aspartate Transferase (AST)
Patient safety measured with lab value AST in IU/L.
Zeitrahmen Up to 28 weeks
Primärer Endpunkt
Safety Lab Alkaline Phosphatase (ALP)
Patient safety measured with lab value ALP in IU/L.
Zeitrahmen Up to 28 weeks
Primärer Endpunkt
Safety Lab Total Bilirubin
Patient safety measured with lab value total bilirubin in mg/dL.
Zeitrahmen Up to 28 weeks
Sekundärer Endpunkt
Muscle strength
Change in muscle strength over time as measured by hand grip and hand-held dynamometry (HHD) in pounds.
Zeitrahmen Up to 28 weeks
Sekundärer Endpunkt
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.
Zeitrahmen Up to 28 weeks
Sekundärer Endpunkt
Forced Vital Capacity (FVC)
Change in respiratory function as measured by Forced Vital Capacity (FVC) in liters.
Zeitrahmen Up to 28 weeks
Sekundärer Endpunkt
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.
Zeitrahmen Up to 28 weeks
Sekundärer Endpunkt
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
Zeitrahmen Up to 28 weeks
Daten
| Startdatum | 29. April 2025 (tatsächlich) |
|---|---|
| Primärer Abschluss | 1. Juli 2028 (geschätzt) |
| Abschluss | 1. Juli 2028 (geschätzt) |
| Erstveröffentlichung | 30. Juli 2024 (tatsächlich) |
| Zuletzt aktualisiert | 8. Juni 2026 |
| Ergebnisse veröffentlicht | Im Registereintrag nicht angegeben |
| Status zuletzt bestätigt | Juni 2026 |
Tatsächlich bedeutet, dass das Ereignis eingetreten ist. Geschätzt bedeutet, dass der Sponsor es erwartet. Die beiden bedeuten Unterschiedliches.
Standorte
6 Studienzentren rekrutieren
United States
| Einrichtung | Stadt | Bundesland oder Region | Status |
|---|---|---|---|
| University of Missouri Health Care | Columbia | Missouri | Rekrutiert |
| The Ohio State University | Columbus | Ohio | Rekrutiert |
| University of Kansas Medical Center | Fairway | Kansas | Rekrutiert |
| Mayo Clinic Florida | Jacksonville | Florida | Rekrutiert |
| University of California, San Francisco | San Francisco | California | Rekrutiert |
| University of Kansas Medical Center: Wichita | Wichita | Kansas | Rekrutiert |
Studiendokumente
In diesem Registereintrag sind keine Dokumente verlinkt.
Änderungen im Zeitverlauf
Seit wir diesen Eintrag erstmals eingelesen haben, wurden keine Änderungen erfasst.
Eine Änderung wird jedes Mal erfasst, wenn der Sponsor den Registereintrag aktualisiert. Status, Daten, Teilnahme und Studienzentren erscheinen hier, sobald sie sich ändern.