Central Adrenal InsufficiencyPhase 2NCT04588688
Mifepristone Dynamic Testing for Diagnosis for Central Adrenal Insufficiency
A Phase 2 study testing Mifepristone in people with Central Adrenal Insufficiency and Mifepristone, run by Tobias Else at 1 site in United States.
Trial summary
The researchers propose the use of mifepristone as an alternative way to test for Central Adrenal Insufficiency (CAI). They want to assess the feasibility of recruitment and the efficacy of the purposed method. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Adrenal Insufficiency, Mifepristone
- What is being tested?
- Mifepristone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2021to 1 Aug 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Completed insulin tolerance testing (ITT) at University of Michigan from 2012 to present.
- Are scheduled to complete ITT.
- Are clinically suspected to have adrenal insufficiency but have not undergone ITT.
Who cannot join
- Female patients who are of child-bearing potential (defined as a sexually mature woman who has not undergone hysterectomy, bilateral oophorectomy bilateral salpingectomy or bilateral tubal ligation/occlusion, at least 12 weeks prior to screening, or who has not been naturally postmenopausal for at least 24 consecutive months prior to study enrollment) and not using non-hormonal contraception.
- Female patients not willing to use non-hormonal contraception for one month following treatment.
- Women who are pregnant or breast feeding.
- Patients with an existing diagnosis of adrenal insufficiency who are on any glucocorticoid replacement other than oral hydrocortisone or prednisone.
- Patients on medications that are strong CYP3A
- Patients taking other medications metabolized by CYP3A
- Patients who have a history of QT prolongation and patients with any recent abnormal electrocardiogram (ECG).
Trial locations and contacts
1 site in 1 country.
About this study
The researchers propose the use of mifepristone as an alternative way to test for Central Adrenal Insufficiency (CAI). They want to assess the feasibility of recruitment and the efficacy of the purposed method.
Read the detailed description
Recruitment for this trial was legally opened on February 17, 2020. When the record was first released, it incorrectly listed the recruitment status as "Not Yet Recruiting." This mistake was noticed before the first participant actually enrolled, May 5, 2021. The decision to terminate for low recruitment was made on Sept 7, 2022, approximately 30 months later, as at that point it was deemed impossible to reach the initial enrollment target of 26.
- Conditions
- Central Adrenal Insufficiency, Mifepristone
- Being tested
- Mifepristone
- Keywords
- Insulin Tolerance Test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MifepristoneDrug
Also called KORLYM®, C1073, RU486
Mifepristone is a selective antagonist of the progesterone receptor at low doses and blocks the glucocorticoid receptor (GR-II) at higher doses. Mifepristone has high affinity for the GR-II receptor but little affinity for the GR-I (MR, mineralocorticoid) receptor.
| Study group | Role | What they receive |
|---|---|---|
| Mifepristone | Experimental | Patients will be provided a single dose of 600 milligram (mg) mifepristone to be administered orally, and subjects will be instructed to take the drug between 10PM and 11PM on Day 1. Receives: Drug: Mifepristone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Study Participants Recruited
Because this was a feasibility trial, the goal was to see how many participants could be successfully recruited. The original intent was for the recruitment period to be for 36 months, with a target enrollment of 26 participants. The trial opened for recruitment on February 17, 2020. Because of low enrollment, the decision to terminate was made on September 7, 2022, approximately 30 months later.
Measured: Up to 88 days
Number of Study Participants With Complete Study Data Captured
Because this was a feasibility trial, the goal was to see how many participants could be successfully recruited. The original intent was for the recruitment period to be for 36 months, with a target enrollment of 26 participants. Because of low enrollment, the decision to terminate was made after the trial had been open for recruitment for approximately 30 months (February 17, 2020 - September 7, 2022).
Measured: 30 days
Secondary outcomes (2)
Peak Cortisol Measured After Mifepristone
Serum cortisol was collected the day after mifepristone administration and insulin tolerance test insulin tolerance test (ITT).
Measured: Day 2 (day after mifepristone administration)
Absolute ACTH After Mifepristone
ACTH level 8:00 am (Day 2) following administration of mifepristone the night before at 10:00 pm.
Measured: Day 2 (day after mifepristone administration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start5 May 2021
- Primary completion1 Aug 2021
- Study completion1 Aug 2021
Why it stopped: low recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Central Adrenal InsufficiencyStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tobias Else
- Sponsor type
- University, hospital or other
- Collaborators
- Corcept Therapeutics
- Responsible party
- Sponsor-investigator, Tobias Else, University of Michigan
- Investigators
- Tobias Else, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04588688
- Sponsor's protocol ID
- HUM00160641
- Status last verified
- May 2023
- First submitted
- 9 Oct 2020
- Last updated
- 12 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mifepristone Dynamic Testing for Diagnosis for Central Adrenal Insufficiency
- ClinicalTrials.gov ID
- NCT04588688
- Acronym / sponsor ID
- HUM00160641
- Conditions
- Central Adrenal Insufficiency, Mifepristone
- Keywords
- Insulin Tolerance Test
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low recruitment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Tobias ElseUniversity, hospital or other
- Collaborators
- Corcept Therapeutics
- Study start
- 5 May 2021 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 19 Oct 2020 (actual)
- Results
- Posted 12 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The researchers propose the use of mifepristone as an alternative way to test for Central Adrenal Insufficiency (CAI). They want to assess the feasibility of recruitment and the efficacy of the purposed method.
Detailed description
Recruitment for this trial was legally opened on February 17, 2020. When the record was first released, it incorrectly listed the recruitment status as "Not Yet Recruiting." This mistake was noticed before the first participant actually enrolled, May 5, 2021. The decision to terminate for low recruitment was made on Sept 7, 2022, approximately 30 months later, as at that point it was deemed impossible to reach the initial enrollment target of 26.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mifepristone | Experimental | Drug: MifepristonePatients will be provided a single dose of 600 milligram (mg) mifepristone to be administered orally, and subjects will be instructed to take the drug between 10PM and 11PM on Day 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Completed insulin tolerance testing (ITT) at University of Michigan from 2012 to present.
- Are scheduled to complete ITT.
- Are clinically suspected to have adrenal insufficiency but have not undergone ITT.
Key exclusion criteria (7 listed)
- Female patients who are of child-bearing potential (defined as a sexually mature woman who has not undergone hysterectomy, bilateral oophorectomy bilateral salpingectomy or bilateral tubal ligation/occlusion, at least 12 weeks prior to screening, or who has not been naturally postmenopausal for at least 24 consecutive months prior to study enrollment) and not using non-hormonal contraception.
- Female patients not willing to use non-hormonal contraception for one month following treatment.
- Women who are pregnant or breast feeding.
- Patients with an existing diagnosis of adrenal insufficiency who are on any glucocorticoid replacement other than oral hydrocortisone or prednisone.
- Patients on medications that are strong CYP3A
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 |
|---|---|---|
| MifepristoneAlso: KORLYM®, C1073, RU486Mifepristone is a selective antagonist of the progesterone receptor at low doses and blocks the glucocorticoid receptor (GR-II) at higher doses. Mifepristone has high affinity for the GR-II receptor but little affinity for the GR-I (MR, mineralocorticoid) receptor. | Drug | Mifepristone |
Primary outcome
Number of Study Participants Recruited
Time frame: Up to 88 days
Because this was a feasibility trial, the goal was to see how many participants could be successfully recruited. The original intent was for the recruitment period to be for 36 months, with a target enrollment of 26 participants. The trial opened for recruitment on February 17, 2020. Because of low enrollment, the decision to terminate was made on September 7, 2022, approximately 30 months later.
Number of Study Participants With Complete Study Data Captured
Time frame: 30 days
Because this was a feasibility trial, the goal was to see how many participants could be successfully recruited. The original intent was for the recruitment period to be for 36 months, with a target enrollment of 26 participants. Because of low enrollment, the decision to terminate was made after the trial had been open for recruitment for approximately 30 months (February 17, 2020 - September 7, 2022).
2 secondary outcomes
Peak Cortisol Measured After Mifepristone
Time frame: Day 2 (day after mifepristone administration)
Absolute ACTH After Mifepristone
Time frame: Day 2 (day after mifepristone administration)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Tobias Else, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mifepristone in people with Central Adrenal Insufficiency and Mifepristone, run by Tobias Else 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 3 inclusion and 7 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 12 Jun 2023. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Study Participants Recruited (time frame: Up to 88 days). The study lists 2 primary outcomes in all. 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 12 Jun 2023.