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NCT04378075 · ClinicalTrials.gov registry record · Phase 2

A Study to Evaluate Efficacy and Safety of Vatiquinone for Treating Mitochondrial Disease in Participants With Refractory Epilepsy

A Phase 2 study, sponsored by PTC Therapeutics.

Terminated
Registry status
Phase 2
Development phase
68
Enrollment target

NCT04378075 is a Phase 2 study that was terminated before completion, run by PTC Therapeutics. The registered enrollment target is 68 participants.

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The verdict

NCT04378075, a Phase 2 study, was terminated before completion, sponsored by PTC Therapeutics.

TERMINATED
Registry status
Phase 2
Development phase
68 participants
Enrollment target

Study Summary

This is a parallel-arm, double-blind, placebo-controlled study with a screening phase that includes a 28-day run-in phase to establish baseline seizure frequency, followed by a 24-week, randomized, placebo-controlled phase. After completion of the randomized, placebo-controlled phase, participants may enter a 48-week, long-term, extension phase during which they will receive open-label treatment with vatiquinone.

Interventions

  • OTHER Placebo
  • DRUG Vatiquinone

Trial Details

FieldValue
Enrollment Target 68 participants
Start Date 2020-09-28
Est. Completion 2023-12-27
Phase Phase 2

Sponsor

PTC Therapeutics

52 total trials

What the Registry Record Tells You About NCT04378075

The ClinicalTrials.gov registry entry for NCT04378075 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 68 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is PTC Therapeutics, which has 52 total studies on file at ClinicalTrials.gov.

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

NCT04378075 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04378075 about?

NCT04378075 is a clinical study titled "A Study to Evaluate Efficacy and Safety of Vatiquinone for Treating Mitochondrial Disease in Participants With Refractory Epilepsy". This is a parallel-arm, double-blind, placebo-controlled study with a screening phase that includes a 28-day run-in phase to establish baseline seizure frequency, followed by a 24-week, randomized, placebo-controlled phase. After completion of the randomized, placebo-controlled phase, participants m...

What is the current status of trial NCT04378075?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 68 participants. The study started on 2020-09-28. Estimated completion is 2023-12-27.

What interventions are being tested in trial NCT04378075?

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

Who is sponsoring clinical trial NCT04378075?

This trial is sponsored by PTC Therapeutics, which has 52 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.