Efficacy of Methimazole Dosing Algorithm

NCT05964452 — Terminated, 11 participants, Cook County Health

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The Efficacy of Cook County Health's Methimazole Dosing Algorithm in the Setting of Ne Onset Graves' Hyperthyroidism

Registry	NCT05964452
Status	Terminated - Unable to reach recruiting goals
Study type	Observational
Enrollment	11 (Actual)
Sponsor	Cook County Health (Other gov)
Conditions	Graves Disease
Interventions	Methimazole Tablets (Drug)
Dates	start 2022-02-14, primary completion 2024-09-17, completion 2024-09-17, first posted 2023-07-28, last updated 2024-12-27
Locations	1 site in United States

-Summary

To prospectively study the efficacy and safety of the Cook County Health (CCH) methimazole (MMI) dosing algorithm in the setting of new onset Graves' disease.

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+Detailed description

To conduct a prospective observational study in 60 patients with newly diagnosed Graves' disease who are either methimazole naive or who have been initiated on MMI within previous 4-6 weeks per CCH algorithm and assess for efficacy and safety of MMI dosing administered. Study group size is based on 90% power and projected efficacy of 70% patients reaching target.

+Arms and interventions

Methimazole Tablets (Drug), also known as Tapazole: Testing dosing algorithm for efficacy.

+Outcome measures

Primary outcomes

Achievement of euthyroid state [17 weeks]: The proportion of patients achieving euthyroid state during the study period

Secondary outcomes

Factors influencing achievement of euthyroid state [17 weeks]: Identifying variables that correlate with achievement of euthyroid state

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Non-pregnant adults (>18 years of age) with new diagnosis of Graves' Disease (elevated free T4, Free T3, low or suppressed TSH, positive TSI and or thyroid eye disease) and
* either drug naïve or who have been initiated on MMI within previous 4-6 weeks per CCH algorithm.

Exclusion Criteria:

* Pregnant patients
* hyperthyroidism due to other causes, example - Toxic Multinodular Goiter, Iodine induced thyrotoxicosis, etc.
* Graves patients who present with atrial fibrillation, CHF or other end organ damage

+Locations (1)

Facility	City	Country	Status
Cook County Health	Chicago, Illinois	United States

+Investigators

Dan Mihailescu, MD, Principal investigator, Cook County Health