Efficacy of Methimazole Dosing Algorithm

Cook County Health

Status: Terminated

Conditions: Graves Disease

Treatments: Drug: Methimazole Tablets

Study type: Observational

Funder types: Other

Identifiers

NCT05964452

22-010

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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