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Triac Trial II in MCT8 Deficiency Patients

StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Primary completion date: May 13, 2024 to Jul 18, 2027v13 Show 4 more changesShow less
    • Study completion date: Jun 2026 to Aug 18, 2027
    • Interventions: Triac (Drug) to Tiratricol (Drug)
    • Secondary endpoints: details revised at 8 of 8 entries
    • Study description expanded, about 2 words
  2. Primary completion date changed from estimate of Jun 2024 to May 13, 2024v12
  3. 2 versions Re-verified since Apr 9, 2024, no change to tracked fieldsv10-v11
  4. Secondary endpoints: details revised at 8 of 8 entries
    • Study sites revised (5)
    v9
  5. Primary completion date: Nov 2023 to Jun 2024v8 Show 7 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 18 to confirmed 22
    • Study sites: 1 to 5
    • Study completion date: Nov 2024 to Jun 2026
    • Eligibility criteria expanded, about 52 words
    • Secondary endpoints: details revised at 1 of 8 entries
    • Study description expanded, about 34 words
Show 6 earlier versionsHide 6 earlier versions
  1. Trial status: Not Yet Recruiting to Recruitingv7 Show 6 more changesShow less
    • Primary completion date: Apr 2023 to Nov 2023
    • Start date changed from estimate of Mar 2020 to Dec 7, 2020
    • Primary endpoints: 1 to 2
    • Study completion date: Jan 2024 to Nov 2024
    • Eligibility criteria shortened, about 12 words
    • Site details revised
  2. Re-verified, no change to tracked fieldsv6
  3. Lead sponsor: Erasmus Medical Center to Rare Thyroid Therapeutics International ABv5 Show 11 more changesShow less
    • Enrollment target: 30 to 18
    • Primary completion date: Jul 2022 to Apr 2023
    • Start date: Jun 2019 to Mar 2020
    • Primary endpoint revised
    • Study completion date: Dec 2022 to Jan 2024
    • Eligibility criteria expanded, about 108 words
    • Secondary endpoints: 6 to 8
    • Study description shortened, about 109 words
    • Site details revised
    • Collaborators expanded, about 3 words
    • Study title expanded, about 1 word
  4. Start date: Jun 2018 to Jun 2019v4
  5. Start date: Jul 2016 to Jun 2018v3
  6. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT02396459
Lead Sponsor Rare Thyroid Therapeutics International AB
Collaborators: Erasmus Medical Center
Conditions
(from sponsor)		 Allan-Herndon-Dudley Syndrome
Related terms Allan-Herndon-Dudley syndrome
Enrollment 22 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov