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NCT04615923 · ClinicalTrials.gov registry record · Phase 2

HEALEY ALS Platform Trial - Regimen D Pridopidine

A Phase 2 study, sponsored by Merit E. Cudkowicz, MD.

Completed
Registry status
Phase 2
Development phase
163
Enrollment target

NCT04615923: Completed Phase 2 study, sponsored by Merit E. Cudkowicz, MD.

NCT04615923 is a Phase 2 study that has completed, run by Merit E. Cudkowicz, MD. The registered enrollment target is 163 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04615923, a Phase 2 study, has completed, sponsored by Merit E. Cudkowicz, MD.

COMPLETED
Registry status
Phase 2
Development phase
163 participants
Enrollment target

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.

Primary Outcome

Change in disease severity over time as measured by the ALS Functional Rating Scale-Revised (ALSFRS-R). Each type of function is scored from 4 (normal) to 0 (no ability), with a maximum total score of 48 and a minimum total score of 0. Patients with higher scores have more physical function.

Interventions

  • DRUG Matching Placebo
  • DRUG Pridopidine

Trial Details

FieldValue
Enrollment Target 163 participants
Start Date 2020-12-18
Est. Completion 2022-07-14
Phase Phase 2
Merit E. Cudkowicz, MD

8 total trials

What the finished NCT04615923 record still lists

NCT04615923 is an interventional study that assigns participants to a tested intervention. The registered 163 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% higher).

The record links to 0 conditions, and to 2 interventions - of which Matching Placebo is the first listed.

NCT04615923 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04615923 about?

NCT04615923 is a clinical study titled "HEALEY ALS Platform Trial - Regimen D Pridopidine". 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.

What is the current status of trial NCT04615923?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 163 participants. The study started on 2020-12-18. Estimated completion is 2022-07-14.

What interventions are being tested in trial NCT04615923?

The interventions under investigation include: Matching Placebo (DRUG), Pridopidine (DRUG).

Who is sponsoring clinical trial NCT04615923?

This trial is sponsored by Merit E. Cudkowicz, MD, which has 8 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04615923's enrollment target sits among peer trials

163 418th of 2000 higher than 1,583 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04615923, the US trial registry maintained by the National Library of Medicine. NCT04615923 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.