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Sodium Channel Blocker

Ranolazine for ALS

Phase 2
Waitlist Available
Led By Jeffrey Statland, MD
Research Sponsored by Jeffrey Statland
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 years or older
Able to swallow pills at the start of the study and expected to for the length of the study
Must not have
Baseline QTc interval prolongation >450 ms for men/ >470 ms for women, history of long QT syndrome, or medications which prolong the QT interval
Disease duration < 5 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 28 weeks

Summary

This trial aims to see if ranolazine is safe and effective in reducing cramps, improving function, and enhancing quality of life in patients with ALS compared to a placebo.

Who is the study for?
This trial is for individuals with ALS, a type of motor neuron disease. Participants should meet specific health criteria to join but the exact inclusion and exclusion details are not provided here.
What is being tested?
The study is testing the safety and effectiveness of Ranolazine compared to a placebo in treating ALS. It will look at how well it reduces cramps, maintains function, and improves quality of life.
What are the potential side effects?
While specific side effects are not listed here, common ones for Ranolazine may include dizziness, headache, constipation or nausea. Placebo typically has no active ingredients so any side effects would be psychological.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I can swallow pills and expect to continue being able to do so.
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I have been diagnosed with ALS according to specific criteria.
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I have had 4 or more cramps per week in the last 2 weeks.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have a long QT interval or take medications that could prolong it.
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My condition was diagnosed less than 5 years ago.
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I use a ventilator for breathing support for more than 12 hours a day.
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I am not currently taking ranolazine or any investigational drug, nor have I taken any in the past 30 days.
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My heart, liver, or kidney disease is not under control with medication.
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My muscle cramp medication dose has been stable for over 30 days, or I haven't taken any in the last 30 days.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 28 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 28 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Frequency of Treatment-Emergent Adverse Events
Muscle cramp frequency
Muscle cramp severity
+8 more
Secondary study objectives
ALS Functional Rating Scale-Revised (ALSFRS-R)
Forced Vital Capacity (FVC)
Lymphocyte Mitochondrial Function
+2 more

Side effects data

From 2015 Phase 4 trial • 31 Patients • NCT02052011
14%
Dizziness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Intervention Group
Placebo Control

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Ranolazine low doseExperimental Treatment1 Intervention
Participants receive Ranolazine 500mg orally twice daily for 24 weeks.
Group II: Ranolazine high doseExperimental Treatment1 Intervention
Participants receive Ranolazine 1000mg orally twice daily for 24 weeks.
Group III: PlaceboPlacebo Group1 Intervention
Participants receive Ranolazine placebo orally twice daily for 24 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ranolazine
2014
Completed Phase 4
~11570

Find a Location

Who is running the clinical trial?

Jeffrey StatlandLead Sponsor
ALS AssociationOTHER
44 Previous Clinical Trials
17,093 Total Patients Enrolled
44 Trials studying Amyotrophic Lateral Sclerosis
17,093 Patients Enrolled for Amyotrophic Lateral Sclerosis
Jeffrey Statland, MDPrincipal InvestigatorUniversity of Kansas Medical Center
5 Previous Clinical Trials
1,244 Total Patients Enrolled
2 Trials studying Amyotrophic Lateral Sclerosis
430 Patients Enrolled for Amyotrophic Lateral Sclerosis
~48 spots leftby Mar 2025
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