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NCT05579327 · ClinicalTrials.gov registry record · Phase 3
Withdrawal of Tiratricol Treatment in Males With Monocarboxylate Transporter 8 Deficiency (MCT8 Deficiency)
A Phase 3 study, sponsored by Rare Thyroid Therapeutics International AB.
- Completed
- Registry status
- Phase 3
- Development phase
- 20
- Enrollment target
NCT05579327: Completed Phase 3 study, sponsored by Rare Thyroid Therapeutics International AB.
NCT05579327 is a Phase 3 study that has completed, run by Rare Thyroid Therapeutics International AB. The registered enrollment target is 20 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05579327, a Phase 3 study, has completed, sponsored by Rare Thyroid Therapeutics International AB.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 20 participants
- Enrollment target
Study Summary
This is a double-blind, randomized phase 3 multicenter placebo-controlled study in at least 16 evaluable male participants diagnosed with MCT8 deficiency. Male participants, from 4 years of age (at randomization) and having demonstrated stable maintenance treatment with tiratricol, will be randomized to receive placebo or tiratricol for 30 days or until reaching the rescue criterion (serum total triiodothyronine \[T3\] \> upper limit of normal \[ULN\] of the participant's normal range, for a sample collected during the 30-day Randomized Treatment Period). The research hypothesis to be tested is that, for participants in the placebo group, removal of tiratricol will lead to an increase of serum total T3 concentration, measured by liquid chromatography with tandem mass spectrometry (LC/MS/MS), above the ULN and requirement of rescue treatment with tiratricol, compared to those who continue to receive tiratricol.
Interventions
- DRUG Placebo
- DRUG Tiratricol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2023-07-21 |
| Est. Completion | 2025-09-03 |
| Phase | Phase 3 |
What the finished NCT05579327 record still lists
NCT05579327 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05579327 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05579327 about?
NCT05579327 is a clinical study titled "Withdrawal of Tiratricol Treatment in Males With Monocarboxylate Transporter 8 Deficiency (MCT8 Deficiency)". This is a double-blind, randomized phase 3 multicenter placebo-controlled study in at least 16 evaluable male participants diagnosed with MCT8 deficiency. Male participants, from 4 years of age (at randomization) and having demonstrated stable maintenance treatment with tiratricol, will be randomize...
What is the current status of trial NCT05579327?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 20 participants. The study started on 2023-07-21. Estimated completion is 2025-09-03.
What interventions are being tested in trial NCT05579327?
The interventions under investigation include: Placebo (DRUG), Tiratricol (DRUG).
Who is sponsoring clinical trial NCT05579327?
This trial is sponsored by Rare Thyroid Therapeutics International AB, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05579327's enrollment target sits among peer trials
20 1956th of 2000 higher than 32 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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