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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05964452
Other study ID # 22-010
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 14, 2022
Est. completion date February 14, 2024

Study information

Verified date September 2023
Source Cook County Health
Contact Dan Mihailescu, MD
Phone 312-864-0531
Email dan.mihailescu@cookcountyhhs.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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 information / eligibility

Status Recruiting
Enrollment 60
Est. completion date February 14, 2024
Est. primary completion date February 14, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
Methimazole Tablets
Testing dosing algorithm for efficacy.

Locations

Country Name City State
United States Cook County Health Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
Cook County Health

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Achievement of euthyroid state The proportion of patients achieving euthyroid state during the study period 17 weeks
Secondary Factors influencing achievement of euthyroid state Identifying variables that correlate with achievement of euthyroid state 17 weeks
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