Graves DiseaseNCT05964452
Efficacy of Methimazole Dosing Algorithm
An observational study of Graves Disease, run by Cook County Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Graves Disease
- What is being tested?
- Methimazole Tablets
- Type of treatment
- Pill or oral medicine
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2022to 17 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with new onset Graves' disease.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Graves Disease
- Being tested
- Methimazole Tablets
- Medical subject headings
- Graves Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methimazole TabletsDrug
Also called Tapazole
Testing dosing algorithm for efficacy.
What is being measured
The primary outcome is the main question the study is designed to answer.
Achievement of euthyroid state
The proportion of patients achieving euthyroid state during the study period
Measured: 17 weeks
Secondary outcomes (1)
Factors influencing achievement of euthyroid state
Identifying variables that correlate with achievement of euthyroid state
Measured: 17 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start14 Feb 2022
- Primary completion17 Sep 2024
- Study completion17 Sep 2024
Why it stopped: Unable to reach recruiting goals
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graves DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook County Health
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dan Mihailescu, Cook County Health
- Investigators
- Dan Mihailescu, MD, Principal investigator, Cook County Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05964452
- Sponsor's protocol ID
- 22-010
- Status last verified
- Sep 2024
- First submitted
- 17 Jul 2023
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study not completed
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Cook County Health's Methimazole Dosing Algorithm in the Setting of Ne Onset Graves' Hyperthyroidism
- ClinicalTrials.gov ID
- NCT05964452
- Acronym / sponsor ID
- 22-010
- Conditions
- Graves Disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Unable to reach recruiting goals
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Cook County HealthOther government
- Study start
- 14 Feb 2022 (actual)
- Primary completion
- 17 Sep 2024 (actual)
- Study completion
- 17 Sep 2024 (actual)
- First posted
- 28 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with new onset Graves' disease.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methimazole TabletsAlso: TapazoleTesting dosing algorithm for efficacy. | Drug | – |
Primary outcome
Achievement of euthyroid state
Time frame: 17 weeks
The proportion of patients achieving euthyroid state during the study period
1 secondary outcome
Factors influencing achievement of euthyroid state
Time frame: 17 weeks
Results and safety
The study was stopped early (reason given: Unable to reach recruiting goals). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Individual participant dataSharing planned: No. Study not completed
Related trials for Graves Disease
RecruitingObservational study
Early Risk Stratification of Thyroid Eye Disease in Newly Diagnosed Graves' Disease
Graves' Orbitopathy, Thyroid Eye Disease, TED
RecruitingPhase 3
A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC PFS in Adult Participants With Graves' Disease.
Graves Disease
RecruitingPhase 1
Evaluation of ETHY-001 for Safety, Tolerability, and Clinical Activity in Thyroid Eye Disease
Thyroid Eye Disease (TED), Graves' Disease
Active, not recruitingPhase 2
Impact of Vitamin D Therapy on Thyroid Function and Antibody Levels in Pediatric Graves' Disease
Graves Disease, Graves' Disease
RecruitingPhase 2
A Study to Learn About The Effects of Felzartamab on Thyroid Function and Its Safety in Adults With Graves' Disease Ages 18 to 75 Years Old
Graves' Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dan Mihailescu, MD principal investigator
Cook County Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Graves Disease, run by Cook County Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Unable to reach recruiting goals). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Achievement of euthyroid state (time frame: 17 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.