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Efficacy of Methimazole Dosing Algorithm

NCT ID: NCT05964452

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

11 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-14

Study Completion Date

2024-09-17

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Graves Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Methimazole Tablets

Testing dosing algorithm for efficacy.

Intervention Type DRUG

Other Intervention Names

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Tapazole

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cook County Health

OTHER_GOV

Sponsor Role lead

Responsible Party

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Dan Mihailescu

MD Endocrinology Cluster Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dan Mihailescu, MD

Role: PRINCIPAL_INVESTIGATOR

Cook County Health

Locations

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Cook County Health

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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22-010

Identifier Type: -

Identifier Source: org_study_id