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NCT02396459 · ClinicalTrials.gov registry record · Phase 2
Triac Trial II in MCT8 Deficiency Patients
A Phase 2 study of Allan-Herndon-Dudley Syndrome, sponsored by Rare Thyroid Therapeutics International AB.
- Active
- Registry status
- Phase 2
- Development phase
- 22
- Enrollment target
- 5
- Study locations
NCT02396459: Active Phase 2 study of Allan-Herndon-Dudley Syndrome, sponsored by Rare Thyroid Therapeutics International AB.
NCT02396459 is a Phase 2 study of Allan-Herndon-Dudley Syndrome that is active but no longer recruiting, run by Rare Thyroid Therapeutics International AB. The registered enrollment target is 22 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). The trial reports 5 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02396459, a Phase 2 study of Allan-Herndon-Dudley Syndrome, is active but no longer recruiting, sponsored by Rare Thyroid Therapeutics International AB.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 22 participants
- Enrollment target
- 5
- Study locations
Study Summary
This study will investigate the effect of treatment with tiratricol (also called Triac) in young boys (≤30 months) with MCT8 deficiency (also called the Allan-Herndon-Dudley syndrome (AHDS)). The hypothesis tested is that treatment with tiratricol will have a beneficial effect on the hypothyroid state in the brain as well as the hyperthyroid state in peripheral organs and tissues in these patients. Patients will initially be treated for 96 weeks with tiratricol, treatment effect on neurodevelopment impairment caused by hypothyroidism and peripheral thyrotoxicosis will be evaluated after 96 weeks treatment. Patients will be offered to continue on treatment for an additional 3 years.
Primary Outcome
To evaluate the effects of tiratricol on neurodevelopment in young MCT8 deficiency patients, measured by the Gross Motor Function Measure (GMFM)-88 assessment. Potential result values range from 0 to 100%, the latter being representative for a 4-year old healthy child. A high score is equivalent to better/more neurodevelopment and is therefore a better outcome than a low score.
Conditions Studied
Interventions
- DRUG Tiratricol
Study Locations (5)
Other
- Charles University and Motol University Hospital; The department of peadiatrics of the 2nd faculty of medicine - Prague
- Charité - Universitätsmedizin Berlin Institut fur experimental paediatrische endokrinologie - Berlin
- Erasmus MC - Rotterdam
Oregon
- Oregon Health & Science University (OHSU) Doernbecher Childrens Hospital - Portland
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2020-12-07 |
| Est. Completion | 2027-08-18 |
| Phase | Phase 2 |
What the registry record for NCT02396459 still lists
NCT02396459 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).
The record links to 1 condition, with Allan-Herndon-Dudley Syndrome appearing as the primary indexed condition, and to 1 intervention - of which Tiratricol is the first listed.
NCT02396459 lists 5 locations in 3 states (Other, Oregon, Pennsylvania).
Frequently Asked Questions
What is clinical trial NCT02396459 about?
NCT02396459 is a clinical study titled "Triac Trial II in MCT8 Deficiency Patients". This study will investigate the effect of treatment with tiratricol (also called Triac) in young boys (≤30 months) with MCT8 deficiency (also called the Allan-Herndon-Dudley syndrome (AHDS)). The hypothesis tested is that treatment with tiratricol will have a beneficial effect on the hypothyroid sta...
What is the current status of trial NCT02396459?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2020-12-07. Estimated completion is 2027-08-18.
What conditions does trial NCT02396459 study?
This clinical trial studies the following conditions: Allan-Herndon-Dudley Syndrome.
What interventions are being tested in trial NCT02396459?
The interventions under investigation include: Tiratricol (DRUG).
Who is sponsoring clinical trial NCT02396459?
This trial is sponsored by Rare Thyroid Therapeutics International AB, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02396459 being conducted?
This trial has 5 study locations across Oregon, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02396459's enrollment target sits among peer trials
22 1790th of 2000 higher than 207 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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