Trial · NCT05579327
Withdrawal of Tiratricol Treatment in Males With Monocarboxylate Transporter 8 Deficiency (MCT8 Deficiency)
NCT05579327, Phase 3, Completed, Rare Thyroid Therapeutics International AB
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Withdrawal of Tiratricol Treatment in Males With Monocarboxylate Transporter 8 Deficiency (MCT8 Deficiency). Trials, record NCT05579327. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05579327
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Withdrawal of Tiratricol Treatment in Males With Monocarboxylate Transporter 8 Deficiency (MCT8 Deficiency)
- NCT number
- NCT05579327
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 20 participants, actual
- Lead sponsor
- Rare Thyroid Therapeutics International AB
- Conditions
- Monocarboxylate Transporter 8 Deficiency, Allan-Herndon-Dudley Syndrome
- Interventions
- Tiratricol, Placebo
- First posted
- 2022-10-13
- Last updated
- 2026-04-08
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Rate of change from baseline in serum total T3 (ln-transformed) during the 30-day double-blind Randomized Treatment Period | Baseline to Day 30 | |
| Primary | Proportion of participants who meet the rescue criterion (serum total T3 > ULN) during the 30-day double-blind Randomized Treatment Period | Baseline to Day 30 | |
| Secondary | Change in serum thyroid hormone variables (T3, T4, TSH, fT3, and fT4) | From i) Baseline to Day 30, ii) Screening to End of Study (up to 26 weeks), iii) first tiratricol administration in Run-in/Dose Titration Period to last measurement prior to randomization (up to 16 weeks) | |
| Secondary | Change in clinical endpoints: Heart rate | From i) Baseline to Day 30, ii) Screening to End of Study (up to 26 weeks), iii) first tiratricol administration in Run-in/Dose Titration Period to last measurement prior to randomization (up to 16 weeks) | |
| Secondary | Change in clinical endpoints: Systolic blood pressure | From i) Baseline to Day 30, ii) Screening to End of Study (up to 26 weeks), iii) first tiratricol administration in Run-in/Dose Titration Period to last measurement prior to randomization (up to 16 weeks) | |
| Secondary | Change in clinical endpoints: Rate pressure product (heart rate × systolic blood pressure) | From i) Baseline to Day 30, ii) Screening to End of Study (up to 26 weeks), iii) first tiratricol administration in Run-in/Dose Titration Period to last measurement prior to randomization (up to 16 weeks) | |
| Secondary | Change in clinical endpoints: Heart rate Z scores | From i) Baseline to Day 30, ii) Screening to End of Study (up to 26 weeks), iii) first tiratricol administration in Run-in/Dose Titration Period to last measurement prior to randomization (up to 16 weeks) | |
| Secondary | Change in clinical endpoints: Body weight | From i) Screening to End of Study (up to 26 weeks), ii) first tiratricol administration in Run-in/Dose Titration Period to last measurement prior to randomization (up to 16 weeks). | |
| Secondary | Safety endpoints: Number of participants with treatment-emergent adverse events (TEAEs) | From first tiratricol administration in Run-in/Dose Titration Period to End of Study (up to 26 weeks). | |
| Secondary | Safety endpoints: Number of participants with TEAEs related to clinical laboratory tests | From first tiratricol administration in Run-in/Dose Titration Period to End of Study (up to 26 weeks). | Safety laboratory variables (full blood count, serum renal and liver biomarkers, total and low-density lipoprotein \[LDL\] cholesterol, and electrolytes). |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05579327
GET https://conductscience.org/api/trials/v1/NCT05579327/registered