Ranolazine for ALS

Recruiting at 6 trial locations

Overseen By Katie Lillig, BS

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Jeffrey Statland

Must not be taking: Ranolazine, QT prolonging drugs

Disqualifiers: Pregnancy, Heart disease, Liver disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

Duration: 24 weeks

72 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

You may need to stop certain medications, especially if they are investigational drugs or affect the QT interval. If you are on ALS modifying medications or medications for muscle cramps, you must be on a stable dose for at least 30 days before joining the trial.

What is the purpose of this trial?

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.

Research Team

Jeffrey Statland

Principal Investigator

University of Kansas Medical Center

Eligibility Criteria

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.

Inclusion Criteria

Breathing assessment called forced vital capacity (FVC) greater than or equal to 50%

I have been diagnosed with ALS according to specific criteria.

I have been on a stable dose of my ALS medication for at least 30 days.

Exclusion Criteria

I do not have a long QT interval or take medications that could prolong it.

Participation in an experimental drug trial less than 30 days before screening

My condition was diagnosed less than 5 years ago.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Ranolazine or placebo orally twice daily for 24 weeks

24 weeks

5 visits (in-person), 4 visits (remote)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Ranolazine

Trial Overview 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.

Participant Groups

Group I: Ranolazine low dose Experimental Treatment 1 Intervention

Participants receive Ranolazine 500mg orally twice daily for 24 weeks.

Group II: Ranolazine high dose Experimental Treatment 1 Intervention

Participants receive Ranolazine 1000mg orally twice daily for 24 weeks.

Group III: Placebo Placebo Group 1 Intervention

Participants receive Ranolazine placebo orally twice daily for 24 weeks.

Who Is Running the Clinical Trial?

Jeffrey Statland

Lead Sponsor

Trials

2

Recruited

100+

Swathy Chandrashekhar, MD

Lead Sponsor

Trials

1

Recruited

70+

ALS Association

Collaborator

Trials

46

Recruited

17,500+