HEALEY ALS Platform Trial - Regimen D Pridopidine

• Status: Enrolling by invitation
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merit E. Cudkowicz, MD
• Collaborator: Prilenia Therapeutics

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• The following exclusion criteria are in addition to the exclusion criteria specified in the Master Protocol (NCT NCT04297683).

1. 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).

2. 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.

3. Participants with known history of long QT syndrome or a first degree relative with this condition.

4. Participants using prohibited medications within the 4 weeks prior to the Regimen Specific Screening Visit, as detailed in section 5.9.

5. Participants using the following medications at the time of the Regimen Specific Screening Visit:

1. Nuedexta - at a dosage higher than 20 mg dextromethorphan + 10 mg quinidine BID

2. Citalopram - at a dosage higher than 20 mg/day

3. Escitalopram - at a dosage higher than 10 mg/day

6. Participants with a known allergy to any ingredient of the study intervention (pridopidine, silicified microcrystalline cellulose, and magnesium stearate).