Efficacy of Methimazole Dosing Algorithm | NCT05964452

Studies
Efficacy of Methimazole Dosing Algorithm

NCT05964452

Sponsor

Cook County Health

Status

Terminated

Last Update Posted

Dec 27, 2024Actual

Enrollment

11Actual

Phase

Not provided

Conditions

Graves Disease

Interventions

Methimazole Tablets

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2024

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Unable to reach recruiting goals

Expanded Access Info

Start Date

Feb 14, 2022Actual

Primary Completion Date

Sep 17, 2024Actual

Completion Date

Sep 17, 2024Actual

First Submitted Date

Jul 17, 2023

First Submission Date that Met QC Criteria

Jul 25, 2023

First Posted Date

Jul 28, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 23, 2024

Last Update Posted Date

Dec 27, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

11Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Methimazole Tablets	Drug	Testing dosing algorithm for efficacy.		Tapazole

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adults with new onset Graves' disease.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dan Mihailescu, MD	Cook County Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cook County Health		Chicago	Illinois	60612	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Study not completed

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006111	Graves Disease

Ancestor Terms

ID	Term
D005094	Exophthalmos
D009916	Orbital Diseases
D005128	Eye Diseases
D006042	Goiter

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008713	Methimazole

Ancestor Terms

ID	Term
D013438	Sulfhydryl Compounds
D013457	Sulfur Compounds
D009930	Organic Chemicals
D007093	Imidazoles

Browse Leaves

Not provided

Browse Branches

Not provided