HEALEY ALS Platform Trial - Regimen D Pridopidine

Last updated: August 12, 2023
Sponsor: Merit E. Cudkowicz, MD
Overall Status: Completed

Phase

2/3

Condition

Amyotrophic Lateral Sclerosis (Als)

Myasthenia Gravis (Chronic Weakness)

Treatment

Matching Placebo

Pridopidine

Clinical Study ID

NCT04615923
2019P003518D
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • The following exclusion criteria are in addition to the exclusion criteria specifiedin 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 significanthistory of arrhythmia, symptomatic or uncontrolled atrial fibrillation despitetreatment, or asymptomatic sustained ventricular tachycardia, or presence of leftbundle branch block.
  3. Participants with known history of long QT syndrome or a first degree relativewith this condition.
  4. Participants using prohibited medications within the 4 weeks prior to the RegimenSpecific Screening Visit, as detailed in section 5.9.
  5. Participants using the following medications at the time of the Regimen SpecificScreening Visit:
  6. Nuedexta - at a dosage higher than 20 mg dextromethorphan + 10 mg quinidineBID
  7. Citalopram - at a dosage higher than 20 mg/day
  8. Escitalopram - at a dosage higher than 10 mg/day
  9. Participants with a known allergy to any ingredient of the study intervention (pridopidine, silicified microcrystalline cellulose, and magnesium stearate).

Study Design

Total Participants: 163
Treatment Group(s): 2
Primary Treatment: Matching Placebo
Phase: 2/3
Study Start date:
December 18, 2020
Estimated Completion Date:
July 14, 2022

Study Description

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. This trial is designed as a perpetual platform trial. This means that there is a single Master Protocol dictating the conduct of the trial. The HEALEY ALS Platform Trial Master Protocol is registered as NCT04297683.

Once a participant enrolls into the Master Protocol and meets all eligibility criteria, the participant will be eligible to be randomized into any currently enrolling regimen. All participants will have an equal chance of being randomized to any currently enrolling regimen.

If a participant is randomized to Regimen D Pridopidine, the participant will complete a screening visit to assess additional Regimen D eligibility criteria. Once Regimen D eligibility criteria are confirmed, participants will complete a baseline assessment and be randomized in a 3:1 ratio to either active pridopidine or matching placebo.

Regimen D will enroll by invitation, as participants may not choose to enroll in Regimen D. Participants must first enroll into the Master Protocol and be eligible to participate in the Master Protocol before being able to be randomly assigned to Regimen D.

For a list of enrolling sites, please see the HEALEY ALS Platform Trial Master Protocol under NCT04297683.

Connect with a study center

  • Healey Center for ALS at Mass General

    Boston, Massachusetts 02114
    United States

    Site Not Available

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