HEALEY ALS Platform Trial - Regimen D Pridopidine

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

163 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-18

Study Completion Date

2022-07-14

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Amyotrophic Lateral Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Pridopidine

Pridopidine is administered orally twice daily for 24 weeks.

Group Type EXPERIMENTAL

Pridopidine

Intervention Type DRUG

Administration: Oral

Dose: 45mg twice daily

Matching Placebo

Matching placebo is administered orally twice daily for 24 weeks.

Group Type PLACEBO_COMPARATOR

Matching Placebo

Intervention Type DRUG

Administration: Oral

Dose: one capsule twice daily

Interventions

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Pridopidine

Administration: Oral

Dose: 45mg twice daily

Intervention Type DRUG

Matching Placebo

Administration: Oral

Dose: one capsule twice daily

Intervention Type DRUG

Eligibility Criteria

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Exclusion Criteria

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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No