Efficacy of Methimazole Dosing Algorithm

NCT05964452 | Terminated

• 1 other identifier: 22-010
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Graves Disease

Outcome Measures

Primary Outcomes (1)

• Achievement of euthyroid state

  The proportion of patients achieving euthyroid state during the study period

  17 weeks

Secondary Outcomes (1)

• Factors influencing achievement of euthyroid state

  17 weeks

Interventions

Methimazole Tablets DRUG

Testing dosing algorithm for efficacy.

Also known as: Tapazole

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with new onset Graves' disease.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cook County Health: lead

Study Sites (1)

Cook County Health

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Graves Disease

Interventions

Methimazole

Condition Hierarchy (Ancestors)

Exophthalmos; Orbital Diseases; Eye Diseases; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Sulfhydryl Compounds; Sulfur Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Dan Mihailescu, MD

  Cook County Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD Endocrinology Cluster Director

Study Record Dates

• First Submitted: July 17, 2023
• First Posted: July 28, 2023
• Study Start: February 14, 2022
• Primary Completion: September 17, 2024
• Study Completion: September 17, 2024
• Last Updated: December 27, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)