NCT06527222ClinicalTrials.gov

A Study of Ranolazine in ALS

Ranolazine in ALS: Safety, and Effect on Cramps, Function and Quality of Life.

قيد التجنيديقبل مشاركين الآن، وفقاً لسجل السجل.

التواصل مع هذه الدراسة

باختصار

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.

المرحلة 2مطلوب 72 مشاركاً6 مواقعدولة واحدة

الفئات

طب الأعصاب74%الغدد الصمّاء والأيض26%

مسجَّلة في سجل واحد

ClinicalTrials.govNCT06527222فتح هذا السجل في ClinicalTrials.govتمت المزامنة قبل شهرين

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هل أنت مهتم بهذه الدراسة؟

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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.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

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.

Methodological rigourDEFINITIVE

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

ScaleSMALL

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

Investigator standingUNKNOWN

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.

ملخص

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.

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.

الحالات

Amyotrophic Lateral Sclerosis

الأهلية

الأهلية
الجنس	الجميع
الأعمار	18 Years – لا حد أقصى
المتطوعون الأصحّاء	لا

الأهلية كما كُتبت في السجل

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.

الأهلية في عبارات بسيطة

لم تُقسَّم معايير هذا السجل إلى عبارات منفصلة بعد. نص السجل أعلاه كامل وهو النسخة المُعتمَدة.

تصميم الدراسة

تصميم الدراسة
نوع الدراسة	تدخّلية
المرحلة	المرحلة 2
التخصيص	معشّاة
نموذج التدخّل	PARALLEL
الغرض الأساسي	TREATMENT
التعمية	QUADRUPLE (4)
التجنيد	مطلوب 72 مشاركاً

الجهة الراعية والمتعاونون

Swathy Chandrashekhar, MBBS الجهة الراعية
ALS Association المتعاونون

الأذرع والتدخلات

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.

التدخلات

دواء Placebo
Ranolazine placebo twice daily
دواء Ranolazine
500mg twice daily
دواء Ranolazine
1000 mg twice daily

مقاييس النتائج

مقياس النتيجة الأولي
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.
الإطار الزمني Up to 28 weeks
مقياس النتيجة الأولي
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.
الإطار الزمني Up to 28 weeks
مقياس النتيجة الأولي
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.
الإطار الزمني Up to 28 weeks
مقياس النتيجة الأولي
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.
الإطار الزمني Up to 28 weeks
مقياس النتيجة الأولي
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
الإطار الزمني Up to 28 weeks
مقياس النتيجة الأولي
Safety Lab Cystatin C
Patient safety measured with lab value Cystatin C in mg/L.
الإطار الزمني Up to 28 weeks
مقياس النتيجة الأولي
Safety Lab Estimated Glomerular Filtration Rate (eGFR)
Patient safety measured with lab value eGFR in mL/min/1.73.
الإطار الزمني Up to 28 weeks
مقياس النتيجة الأولي
Safety Lab Alanine Transaminase (ALT)
Patient safety measured with lab value ALT in IU/L.
الإطار الزمني Up to 28 weeks
مقياس النتيجة الأولي
Safety Lab Aspartate Transferase (AST)
Patient safety measured with lab value AST in IU/L.
الإطار الزمني Up to 28 weeks
مقياس النتيجة الأولي
Safety Lab Alkaline Phosphatase (ALP)
Patient safety measured with lab value ALP in IU/L.
الإطار الزمني Up to 28 weeks
مقياس النتيجة الأولي
Safety Lab Total Bilirubin
Patient safety measured with lab value total bilirubin in mg/dL.
الإطار الزمني Up to 28 weeks
مقياس النتيجة الثانوي
Muscle strength
Change in muscle strength over time as measured by hand grip and hand-held dynamometry (HHD) in pounds.
الإطار الزمني Up to 28 weeks
مقياس النتيجة الثانوي
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.
الإطار الزمني Up to 28 weeks
مقياس النتيجة الثانوي
Forced Vital Capacity (FVC)
Change in respiratory function as measured by Forced Vital Capacity (FVC) in liters.
الإطار الزمني Up to 28 weeks
مقياس النتيجة الثانوي
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.
الإطار الزمني Up to 28 weeks
مقياس النتيجة الثانوي
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
الإطار الزمني Up to 28 weeks

التواريخ

التواريخ
تاريخ البدء	29 أبريل 2025 (فعلي)
الإتمام الأولي	1 يوليو 2028 (تقديري)
الإتمام	1 يوليو 2028 (تقديري)
أول نشر	30 يوليو 2024 (فعلي)
آخر تحديث	8 يونيو 2026
النتائج منشورة	غير مذكور في سجل السجل
آخر تأكيد للحالة	يونيو 2026

فعلي يعني أن الحدث وقع. تقديري يعني أن الجهة الراعية تتوقعه. للكلمتين معنيان مختلفان.

المواقع

6 مواقع قيد التجنيد

United States

United States
المنشأة	المدينة	الولاية أو المنطقة	الحالة
University of Missouri Health Care	Columbia	Missouri	قيد التجنيد
The Ohio State University	Columbus	Ohio	قيد التجنيد
University of Kansas Medical Center	Fairway	Kansas	قيد التجنيد
Mayo Clinic Florida	Jacksonville	Florida	قيد التجنيد
University of California, San Francisco	San Francisco	California	قيد التجنيد
University of Kansas Medical Center: Wichita	Wichita	Kansas	قيد التجنيد

مستندات الدراسة

لا تُرتبط أي مستندات في سجل السجل هذا.

التغيّرات عبر الزمن

لم تُسجَّل أي تغييرات منذ أن أدرجنا هذا السجل لأول مرة.

يُسجَّل تغيير في كل مرة تحدّث فيها الجهة الراعية سجل السجل. تظهر هنا الحالة والتواريخ والتجنيد والمواقع كلما تغيّرت.

السجل: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT06527222