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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 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. The trial reports 5 study locations across 3 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02396459
The ClinicalTrials.gov registry entry for NCT02396459 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 22 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 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 reports 5 study locations spanning 3 distinct geographic areas - top geographies include 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.
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