Methimazole in Graves' Disease - a Randomised Controlled Trial Comparing the Computer-aided Treatment DigiThy Versus Usual Care

Graves Disease Clinical Trial

Official title:

Guiding Methimazole Therapy in Graves' Disease - a Randomised Controlled Trial Comparing a Computer-aided Treatment (Digital Thyroid, DigiThy) Versus Usual Care

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06327828
• Other study ID #: 32-663
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: October 1, 2026

Study information

• Verified date: March 2024
• Source: Medical University of Graz
• Contact: Verena Theiler-Schwetz, MD, PhD
• Phone: ++4331638582383
• Email: verena.schwetz[@]medunigraz.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to compare two methods of guiding methimazole therapy in patients with Graves' disease: methimazole dose adjustments based on a new semi-automated computer-guided treatment (based on a mathematical model) or based on the treating physician's decision (i.e. usual care). The main question it aims to answer is whether semi-automated computer-guided treatment is not inferior to usual care in terms of safety, the time it takes to achieve euthyroidism and the methimazole dose required.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 52
• Est. completion date: October 1, 2026
• Est. primary completion date: October 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Active Graves' hyperthyroidism [Thyroid-stimulating hormone <0.1 mU/L, elevated free thyroxine levels (fT4) above the upper limit of normal and positive Thyrotropin receptor antibody (TRAb) according to local laboratory results], measured within the last month prior to the inclusion date
• Patients not yet receiving antithyroid treatment, or having received antithyroid treatment continuously for less than 4 weeks, or relapse or recurrence of Graves' hyperthyroidism defined as patients previously having received and discontinued treatment with antithyroid drugs for at least 4 weeks)
• Age 18 years or older
• Provision of written informed consent

Exclusion Criteria:

• Previous treatment with radioactive iodine
• Ongoing antithyroid treatment for more than one month
• Pregnancy
• Treatment with propylthiouracil

Related Conditions & MeSH terms

• Graves Disease

Intervention

Device:
• Semi-automated computer-aided treatment (Digital Thyroid, DigiThy)
Semi-automated computer-aided treatment based on a mathematical model

Procedure:
• Usual care
Guiding methimazole therapy based on the treating physician's decision

Locations

Country	Name	City	State
Austria	Medical University of Graz	Graz

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Graz	Graz University of Technology

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary aim is to compare semi-automated computer-guided treatment with usual care in terms of their performance indices	The performance index is the deviation from the desired free thyroxine (fT4) value	18 months
Secondary	Comparison in terms of dosing and penalties	Calculated value as a combination of methimazole dosing and tracking penalties	18 months
Secondary	Comparison based on free thyroxine (fT4) target range	Comparison based on free thyroxine (fT4) target range	18 months