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NCT04641962 · ClinicalTrials.gov registry record · Phase 2

A Study to Evaluate ASP0367 in Participants With Primary Mitochondrial Myopathy

A Phase 2 study, sponsored by Astellas Pharma.

Terminated
Registry status
Phase 2
Development phase
34
Enrollment target

NCT04641962: Clinical Trial Phase 2 study, sponsored by Astellas Pharma.

NCT04641962 is a Phase 2 study that was terminated before completion, run by Astellas Pharma. The registered enrollment target is 34 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04641962, a Phase 2 study, was terminated before completion, sponsored by Astellas Pharma.

TERMINATED
Registry status
Phase 2
Development phase
34 participants
Enrollment target

Study Summary

The purpose of this study was to evaluate the dose response of Bocidelpar on functional improvement relative to placebo, safety, and tolerability in participants with Primary Mitochondrial Myopathy.

Primary Outcome

6MWT assessed functional capacity and endurance by measuring the distance walked in 6 minutes. This test helped to assess exercise tolerance, physical fitness, disease progression, and treatment effectiveness in individuals with myopathy. The total distance walked by a participant, as well as distance per minute was calculated by rounding to the nearest meter.

Interventions

  • DRUG Placebo
  • DRUG Bocidelpar

Trial Details

FieldValue
Enrollment Target 34 participants
Start Date 2021-05-24
Est. Completion 2024-05-08
Phase Phase 2
Astellas Pharma

165 total trials

Why NCT04641962 stopped before completion

NCT04641962 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower).

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

NCT04641962 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04641962 about?

NCT04641962 is a clinical study titled "A Study to Evaluate ASP0367 in Participants With Primary Mitochondrial Myopathy". The purpose of this study was to evaluate the dose response of Bocidelpar on functional improvement relative to placebo, safety, and tolerability in participants with Primary Mitochondrial Myopathy.

What is the current status of trial NCT04641962?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 34 participants. The study started on 2021-05-24. Estimated completion is 2024-05-08.

What interventions are being tested in trial NCT04641962?

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

Who is sponsoring clinical trial NCT04641962?

This trial is sponsored by Astellas Pharma, which has 165 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04641962's enrollment target sits among peer trials

34 1539th of 2000 higher than 448 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 NCT04641962, the US trial registry maintained by the National Library of Medicine. NCT04641962 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.