HEALEY ALS Platform Trial - Regimen D Pridopidine

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Amyotrophic Lateral Sclerosis

In brief

The HEALEY ALS Platform Trial is a perpetual multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of ALS. Regimen D will evaluate the safety and efficacy of a single study drug, pridopidine, in participants with ALS.

Key facts

Study ID

NCT04615923

Run by

Merit E. Cudkowicz, MD

People needed

163

Starts

2020-12-18

Expected to finish

2022-07-14

Last updated by the study team

2023-08-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• No additional inclusion criteria beyond the inclusion criteria specified in the Master Protocol (NCT NCT04297683).

You may not qualify if…

• The following exclusion criteria are in addition to the exclusion criteria specified in the Master Protocol (NCT NCT04297683).
• Participants with a confirmed prolonged Fridericia-corrected QT (QTcF) interval (defined as a QTcF interval of >450 ms for men and >470 ms for women).
• Participants with clinically significant heart disease, clinically significant history of arrhythmia, symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia, or presence of left bundle branch block.
• Participants with known history of long QT syndrome or a first degree relative with this condition.
• Participants using prohibited medications within the 4 weeks prior to the Regimen Specific Screening Visit, as detailed in section 5.9.
• Participants using the following medications at the time of the Regimen Specific Screening Visit:
• Nuedexta - at a dosage higher than 20 mg dextromethorphan + 10 mg quinidine BID
• Citalopram - at a dosage higher than 20 mg/day
• Escitalopram - at a dosage higher than 10 mg/day
• Participants with a known allergy to any ingredient of the study intervention (pridopidine, silicified microcrystalline cellulose, and magnesium stearate).

Where it is running

• Healey Center for ALS at Mass General — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.