Efficacy of Methimazole Dosing Algorithm

September 19, 2023 updated by: Dan Mihailescu, Cook County Health

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adults with new onset Graves' disease.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Achievement of euthyroid state
Time Frame: 17 weeks
The proportion of patients achieving euthyroid state during the study period
17 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Factors influencing achievement of euthyroid state
Time Frame: 17 weeks
Identifying variables that correlate with achievement of euthyroid state
17 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cook County Health

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 14, 2022

Primary Completion (Estimated)

February 14, 2024

Study Completion (Estimated)

February 14, 2024

Study Registration Dates

First Submitted

July 17, 2023

First Submitted That Met QC Criteria

July 25, 2023

First Posted (Actual)

July 28, 2023

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 19, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-010

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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