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NCT04475549 · ClinicalTrials.gov registry record · Phase 2
Phase 2a Study of IW-6463 in Adults Diagnosed With Mitochondrial Encephalomyopathy, Lactic Acidosis, and Stroke-like Episodes (MELAS)
A Phase 2 study, sponsored by Tisento Therapeutics.
- Terminated
- Registry status
- Phase 2
- Development phase
- 8
- Enrollment target
NCT04475549: Clinical Trial Phase 2 study, sponsored by Tisento Therapeutics.
NCT04475549 is a Phase 2 study that was terminated before completion, run by Tisento Therapeutics. The registered enrollment target is 8 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04475549, a Phase 2 study, was terminated before completion, sponsored by Tisento Therapeutics.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 8 participants
- Enrollment target
Study Summary
This is a single-arm study to evaluate safety and tolerability of oral IW-6463 in adults diagnosed with MELAS.
Primary Outcome
A TEAE is defined as an adverse event (AE) with an onset that occurs between the first dose of study drug and the end of study period. AEs are defined as an untoward medical occurrence that does not necessarily have a causal relationship with study drug treatment.
Interventions
- DRUG IW-6463 Tablets
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2020-11-13 |
| Est. Completion | 2022-01-23 |
| Phase | Phase 2 |
Why NCT04475549 stopped before completion
NCT04475549 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 1 intervention - of which IW-6463 Tablets is the first listed.
NCT04475549 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04475549 about?
NCT04475549 is a clinical study titled "Phase 2a Study of IW-6463 in Adults Diagnosed With Mitochondrial Encephalomyopathy, Lactic Acidosis, and Stroke-like Episodes (MELAS)". This is a single-arm study to evaluate safety and tolerability of oral IW-6463 in adults diagnosed with MELAS.
What is the current status of trial NCT04475549?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 8 participants. The study started on 2020-11-13. Estimated completion is 2022-01-23.
What interventions are being tested in trial NCT04475549?
The interventions under investigation include: IW-6463 Tablets (DRUG).
Who is sponsoring clinical trial NCT04475549?
This trial is sponsored by Tisento Therapeutics, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04475549's enrollment target sits among peer trials
8 1990th of 2000 higher than 5 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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