Efficacy of Methimazole Dosing Algorithm

Graves Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05964452
• Other study ID #: 22-010
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Graves Disease

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