Phase 3
N=30
An Extension Study of CORLUX in the Treatment of Endogenous Cushing's Syndrome
Cushing's Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT00936741 ↗Enrolled (actual)
30
Serious AEs
60.0%
Results posted
Apr 2014
Primary outcome: Primary: Number of Participants With Adverse Events — 30 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- mifepristone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Corcept Therapeutics
- Primary completion
- Sep 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
30 | — |
| SECONDARY The Long-term Benefit of Mifepristone Treatment in Cushing's Syndrome as Measured by Changes in the Score on the Physician's Global Assessment of Disease Severity |
3.3 | — |
Summary
Participants in study C-1073-400 (NCT00569582) will be invited to participate in this extension study to examine the long term safety of mifepristone in the treatment of the signs and symptoms of endogenous Cushing's syndrome. Total treatment duration may be up to 12 months or longer at the discretion of the Investigator.
Eligibility Criteria
Inclusion Criteria
- Have completed the Week 24 visit and the 6-Week Follow-up visit of Corcept Study C-1073-400 (NCT00569582).
- In the opinion of the Investigator, are expected to maintain clinical benefit from mifepristone.
- Women of childbearing potential have a negative serum pregnancy test at Entry.
- Women of childbearing potential must be willing to use non-hormonal, medically acceptable methods of contraception during the study.
- Are able to provide written informed consent
- Are able to return to the investigative site to complete the study evaluations outlined in the protocol.
- Will not use systemic estrogens during the study.
Exclusion Criteria
- Have an acute or unstable medical problem, which could be aggravated by mifepristone treatment.
- Are taking medications within 14 days of the Entry visit that a) have a large first pass metabolism that is largely mediated by CYP3A4 and which have a narrow therapeutic margin; and/or b) are strong CYP3A4 inhibitors.
- Female patients of reproductive potential, who are pregnant or who are unable or unwilling to use medically acceptable, non-hormonal methods of contraception during the study.
- Have received investigational treatment (drug, biological agent or device) other than CORLUX (mifepristone) within 30 days of Entry
- Have a history of an allergic reaction or intolerance to CORLUX (mifepristone)
- Have uncorrected hypokalemia (potassium level of 1.5 ULN, elevated ALT or AST ≥3X the upper limit of normal.
Data sourced from ClinicalTrials.gov (NCT00936741). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.