Methimazole in Graves' Disease - Comparing the Computer-aided Treatment DigiThy Versus Usual Care

NCT ID: NCT06327828

Last Updated: 2024-05-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2026-10-01

Brief 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.

Conditions

Graves Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Semi-automated computer-aided treatment

Treatment based on the dosing suggestions by a mathematical algorithm and cross-checked by the treating physician

Group Type: EXPERIMENTAL

Semi-automated computer-aided treatment (Digital Thyroid, DigiThy)

Intervention Type: DEVICE

Semi-automated computer-aided treatment based on a mathematical model

Usual care

Treatment based on the dosing suggestions by the treating physician

Group Type: ACTIVE_COMPARATOR

Usual care

Intervention Type: PROCEDURE

Guiding methimazole therapy based on the treating physician's decision

Interventions

Semi-automated computer-aided treatment (Digital Thyroid, DigiThy)

Semi-automated computer-aided treatment based on a mathematical model

Intervention Type: DEVICE

Usual care

Guiding methimazole therapy based on the treating physician's decision

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Graz University of Technology

OTHER

Sponsor Role: collaborator

Medical University of Graz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stefan Pilz, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Graz

Locations

Medical University of Graz

Graz, , Austria

Countries

Austria

Central Contacts

Verena Theiler-Schwetz, MD, PhD

Role: CONTACT

verena.schwetz@medunigraz.at

++4331638582383

Stefan Pilz, MD, PhD

Role: CONTACT

Facility Contacts

Verena Theiler-Schwetz, MD, PhD

Role: primary

Other Identifiers

32-663

Identifier Type: -

Identifier Source: org_study_id