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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.
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
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2020-09-28 |
| Est. Completion | 2023-12-27 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗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.
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