Ranolazine for ALS

Recruiting in Palo Alto (17 mi)

Overseen ByJeffrey Statland

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Jeffrey Statland

Prior Safety Data

Trial Summary

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.

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

I am 18 years old or older.

I can swallow pills and expect to continue being able to do so.

I have been diagnosed with ALS according to specific criteria.

I have had 4 or more cramps per week in the last 2 weeks.

Exclusion Criteria

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

My condition was diagnosed less than 5 years ago.

I use a ventilator for breathing support for more than 12 hours a day.

I am not currently taking ranolazine or any investigational drug, nor have I taken any in the past 30 days.

My heart, liver, or kidney disease is not under control with medication.

My muscle cramp medication dose has been stable for over 30 days, or I haven't taken any in the last 30 days.

Participant Groups

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.

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.