Efficacy of Methimazole Dosing Algorithm

• Sponsor: Cook County Health (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05964452
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Graves Disease	Drug: Methimazole Tablets

Detailed Description

We aim 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. The patient number is based on 90% power and projected efficacy of 70% patients reaching target.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 60 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: The Efficacy of Cook County Health's Methimazole Dosing Algorithm in the Setting of ne Onset Graves' Hyperthyroidism
• Actual Study Start Date: Feb 14, 2022
• Anticipated Primary Completion Date: Feb 14, 2024
• Anticipated Study Completion Date: Feb 14, 2024

Outcome Measures

Primary Outcome Measures

1. Achievement of euthyroid state [17 weeks]

   The proportion of patients achieving euthyroid state during the study period

Secondary Outcome Measures

1. Factors influencing achievement of euthyroid state [17 weeks]

   Identifying variables that correlate with achievement of euthyroid state

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cook County Health	Chicago	Illinois	United States	60612

Sponsors and Collaborators

• Cook County Health

Investigators

• Principal Investigator: Dan Mihailescu, MD, Cook County Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dan Mihailescu, MD Endocrinology Cluster Director, Cook County Health
• ClinicalTrials.gov Identifier: NCT05964452
• Other Study ID Numbers: 22-010
• First Posted: Jul 28, 2023
• Last Update Posted: Jul 28, 2023
• Last Verified: Jul 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Graves Disease; Methimazole

Study Results

No Results Posted as of Jul 28, 2023