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NCT Number: NCT06327828

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

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.

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Key information

Conditions

Graves Disease Autoimmune Diseases Endocrine System Diseases Exophthalmos Eye Diseases Goiter Hyperthyroidism Immune System Diseases Orbital Diseases Thyroid Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Graz

Graz, 8044, Austria

Location contact

Verena Theiler-Schwetz, MD, PhD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

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

usual care

Procedure

Guiding methimazole therapy based on the treating physician's decision

Primary outcomes

  1. The primary aim is to compare semi-automated computer-guided treatment with usual care in terms of their performance indices

    Time frame: 18 months

    The performance index is the deviation from the desired free thyroxine (fT4) value

Secondary outcomes

  1. Comparison in terms of cumulative methimazole dosing

    Time frame: 18 months

    Comparison in terms of cumulative methimazole dosing

  2. Comparison based on free thyroxine (fT4) target range

    Time frame: 18 months

    Comparison based on free thyroxine (fT4) target range

Study contacts

Contact information is provided by the study sponsor or research team.

Stefan Pilz, MD, PhD

CONTACT

Verena Theiler-Schwetz, MD, PhD

CONTACT

[email protected]

++4331638582383

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Collaborators

  • Graz University of Technology

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 25, 2024
Registry last updated
May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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