An Extension Study of CORLUX in the Treatment of Endogenous Cushing's Syndrome (NCT00936741) | Clinical Trial Compass
CompletedPhase 3
An Extension Study of CORLUX in the Treatment of Endogenous Cushing's Syndrome
United States30 participantsStarted 2009-07
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 \<3.5 mEq/L) at Entry. Spironolactone or eplerenone is allowed t…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.