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Thyroid Hormone

Tiratricol Withdrawal for Monocarboxylate Transporter 8 Deficiency (ReTRIACt Trial)

Phase 3

Recruiting

Led By Andrew J. Bauer, MD

Research Sponsored by Rare Thyroid Therapeutics International AB

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male participants diagnosed with a pathogenic mutation in the MCT8 gene, confirmed with a genetic test

Timeline

Screening 3 weeks

Treatment Varies

Follow Up screening period, days 1, 8, 15, 22, and 30, follow-up period (up to approximately 26 weeks)

Awards & highlights

ReTRIACt Trial Summary

This trial tests if removing a drug can bring a hormone in male participants with a certain deficiency back to normal.

Who is the study for?

This trial is for male participants aged 4 or older with MCT8 deficiency, a genetic condition. They must have been on stable tiratricol treatment and not have major illnesses or surgeries that could affect the study. Participants need to weigh at least 10 kg and cannot be in other studies or have allergies to tiratricol components.Check my eligibility

What is being tested?

The study tests if stopping tiratricol increases serum total T3 levels compared to those who continue it. It's a double-blind, randomized trial where males with MCT8 deficiency either receive placebo or continue tiratricol for up to 30 days.See study design

What are the potential side effects?

Potential side effects of tiratricol may include allergic reactions for those sensitive to its ingredients. The exact side effects are not listed but typically would be monitored closely during the trial.

ReTRIACt Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a male with a confirmed MCT8 gene mutation.

ReTRIACt Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ screening period, days 1, 8, 15, 22, and 30, follow-up period (up to approximately 26 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~screening period, days 1, 8, 15, 22, and 30, follow-up period (up to approximately 26 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and screening period, days 1, 8, 15, 22, and 30, follow-up period (up to approximately 26 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Blindness

Secondary outcome measures

Change from baseline in weight

Electrocardiogram

Change from baseline to end of study for ECG measures (heart rate descriptive analysis)

+18 more

Other outcome measures

Change in serum thyroid hormone variables from baseline (start of the Randomized Treatment Period) to the end of the Follow-up Period

Change in serum thyroid hormone variables from the end of the Randomized Treatment Period to the end of the Follow-up Period

Adverse reaction to drug

+6 more

ReTRIACt Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TiratricolExperimental Treatment1 Intervention

Group II: PlaceboPlacebo Group1 Intervention

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Premier Research Group plcIndustry Sponsor

62 Previous Clinical Trials

69,359 Total Patients Enrolled

Rare Thyroid Therapeutics International ABLead Sponsor

3 Previous Clinical Trials

43 Total Patients Enrolled

1 Trials studying Monocarboxylate Transporter 8 Deficiency

Egetis TherapeuticsIndustry Sponsor

9 Previous Clinical Trials

905 Total Patients Enrolled

1 Trials studying Monocarboxylate Transporter 8 Deficiency

Media Library

Tiratricol (Thyroid Hormone) Clinical Trial Eligibility Overview. Trial Name: NCT05579327 — Phase 3

Monocarboxylate Transporter 8 Deficiency Research Study Groups: Tiratricol, Placebo

Monocarboxylate Transporter 8 Deficiency Clinical Trial 2023: Tiratricol Highlights & Side Effects. Trial Name: NCT05579327 — Phase 3

Tiratricol (Thyroid Hormone) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05579327 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does Tiratricol pose any potential health risks for those who take it?

"The safety of Tiratricol is rated a 3 by our Power team due to the available clinical evidence from its Phase 3 trial, which corroborates both effectiveness and security."

Answered by AI

Are enrollment opportunities still available for this research experiment?

"Confirmation of candidacy recruitment is present on clinicaltrials.gov; this trial was initially approved to begin recruiting patients in July 21st 2023 with a final edit taking place at the end of August 22nd 2023."

Answered by AI

How many individuals are being enrolled in this research project?

"Affirmative, according to clinicaltrials.gov this research is still actively recruiting participants. This project was first published on July 21st 2023 and the details were recently updated August 22nd of the same year. 16 individuals need to be recruited from 2 separate study sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Withdrawal of Tiratricol Treatment in Males With Monocarboxylate Transporter 8 Deficiency (MCT8 Deficiency)

2023. "Withdrawal of Tiratricol Treatment in Males With Monocarboxylate Transporter 8 Deficiency (MCT8 Deficiency)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05579327.