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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
52
Semi-automated computer-aided treatment based on a mathematical model
Guiding methimazole therapy based on the treating physician's decision
Medical University of Graz
Graz, Austria
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
Time frame: 18 months
Comparison in terms of cumulative methimazole dosing
Comparison in terms of cumulative methimazole dosing
Time frame: 18 months
Comparison based on free thyroxine (fT4) target range
Comparison based on free thyroxine (fT4) target range
Time frame: 18 months
Stefan Pilz, MD, PhD
CONTACT
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