Efficacy of Methimazole Dosing Algorithm
Terminated
- Conditions
- Graves Disease
- Registration Number
- NCT05964452
- Lead Sponsor
- Cook County Health
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 11
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Achievement of euthyroid state 17 weeks The proportion of patients achieving euthyroid state during the study period
- Secondary Outcome Measures
Name Time Method Factors influencing achievement of euthyroid state 17 weeks Identifying variables that correlate with achievement of euthyroid state
Trial Locations
- Locations (1)
Cook County Health
🇺🇸Chicago, Illinois, United States