Trial Outcomes & Findings for Mifepristone Dynamic Testing for Diagnosis for Central Adrenal Insufficiency (NCT NCT04588688)
NCT ID: NCT04588688
Last Updated: 2023-06-12
Results Overview
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.
TERMINATED
PHASE2
3 participants
Up to 88 days
2023-06-12
Participant Flow
The results from the insulin tolerance test (ITT) served to group the participants into two arms for analysis: high suspicion for adrenal sufficiency (maximum cortisol greater than or equal to 15 microg/dl) or high suspicion for adrenal insufficiency (maximum cortisol less than 15 microg/dl). The ITT serves as the gold standard and the cut-off of 15 microg/dl was used as a conservative cut-off in accordance with local experience with this test.
Participant milestones
| Measure |
Mifepristone
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.
Mifepristone: 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.
|
|---|---|
|
Overall Study
STARTED
|
3
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Only 1 participant was in the ITT Less Than 15 Max Cortisol arm. Data are not shared to preserve privacy.
Baseline characteristics by cohort
| Measure |
Greater or Equal to 15 Max Cortisol
n=2 Participants
Suspected adrenal sufficient by ITT.
|
Less Than 15 Max Cortisol
n=1 Participants
Suspected adrenal insufficient by ITT.
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
50 - 59 years
|
2 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
2 Participants
n=3 Participants
|
|
Age, Customized
60 - 69 years
|
0 Participants
n=2 Participants
|
1 Participants
n=1 Participants
|
1 Participants
n=3 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
2 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=2 Participants
|
1 Participants
n=1 Participants
|
1 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=2 Participants
|
1 Participants
n=1 Participants
|
3 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
1 Participants
n=3 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=2 Participants
|
1 Participants
n=1 Participants
|
2 Participants
n=3 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=2 Participants
|
1 participants
n=1 Participants
|
3 participants
n=3 Participants
|
|
Peak cortisol measured after Insulin Tolerance Testing (ITT)
|
24.4 micrograms per deciliter
STANDARD_DEVIATION 3.15 • n=2 Participants • Only 1 participant was in the ITT Less Than 15 Max Cortisol arm. Data are not shared to preserve privacy.
|
—
|
24.4 micrograms per deciliter
STANDARD_DEVIATION 3.15 • n=2 Participants • Only 1 participant was in the ITT Less Than 15 Max Cortisol arm. Data are not shared to preserve privacy.
|
PRIMARY outcome
Timeframe: Up to 88 daysBecause 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.
Outcome measures
| Measure |
Mifepristone
n=3 Participants
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.
Mifepristone: 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.
|
ITT Less Than 15 Max Cortisol
Suspected adrenal insufficient by ITT.
|
|---|---|---|
|
Number of Study Participants Recruited
|
3 Participants
|
—
|
PRIMARY outcome
Timeframe: 30 daysBecause 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).
Outcome measures
| Measure |
Mifepristone
n=3 Participants
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.
Mifepristone: 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.
|
ITT Less Than 15 Max Cortisol
Suspected adrenal insufficient by ITT.
|
|---|---|---|
|
Number of Study Participants With Complete Study Data Captured
|
3 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 2 (day after mifepristone administration)Population: Only 1 participant was in the ITT Less Than 15 Max Cortisol arm. Results are not shared to preserve privacy.
Serum cortisol was collected the day after mifepristone administration and insulin tolerance test insulin tolerance test (ITT).
Outcome measures
| Measure |
Mifepristone
n=2 Participants
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.
Mifepristone: 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.
|
ITT Less Than 15 Max Cortisol
Suspected adrenal insufficient by ITT.
|
|---|---|---|
|
Peak Cortisol Measured After Mifepristone
|
13.9 micrograms per deciliter
Standard Deviation 0.75
|
—
|
SECONDARY outcome
Timeframe: Day 2 (day after mifepristone administration)Population: Only 1 participant was in the ITT Less Than 15 Max Cortisol arm. Results are not shared to preserve privacy.
ACTH level 8:00 am (Day 2) following administration of mifepristone the night before at 10:00 pm.
Outcome measures
| Measure |
Mifepristone
n=2 Participants
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.
Mifepristone: 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.
|
ITT Less Than 15 Max Cortisol
Suspected adrenal insufficient by ITT.
|
|---|---|---|
|
Absolute ACTH After Mifepristone
|
18.5 Picogram per milliliter
Standard Deviation 1.5
|
—
|
Adverse Events
Mifepristone
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place