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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 is a Phase 3 study that has completed, run by Rare Thyroid Therapeutics International AB. The registered enrollment target is 20 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05579327
The ClinicalTrials.gov registry entry for NCT05579327 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rare Thyroid Therapeutics International AB, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05579327 reports 0 study locations.
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.
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