Clinical Trial: A Study of the Efficacy and Safety of CORLUX in the Treatment of Endogenous Cushing's Syndrome
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: An Open-label Study of the Efficacy and Safety of CORLUX (Mifepristone) in the Treatment of the Signs and Symptoms of Endogenous Cushing's Syndrome
Brief Summary: Patients will receive Corlux (mifepristone) daily for up to 24 weeks. Assessments of the signs and symptoms of Cushing's syndrome will be obtained.
Cushing's syndrome is a relatively rare disorder caused by prolonged exposure to high levels of the glucocorticoid hormone cortisol. Cushing's syndrome may result from elevated endogenous or exogenous sources of cortisol. Endogenous Cushing's syndrome resulting from cortisol overproduction by the adrenal glands is the subject of this protocol. Patients with exogenous Cushing's syndrome, which develops as a side effect of chronic administration of high doses of glucocorticoids, are not eligible for enrollment in this study.
This will evaluate the safety and efficacy of mifepristone for treatment of the signs and symptoms of hypercortisolemia in patients with endogenous Cushing's syndrome from ACTH-dependent or adrenal disorders.
The study will enroll subjects for whom the investigator has determined that medical treatment of endogenous hypercortisolemia is needed. Medical treatment may be intended to treat the effects of persistent or recurrent hypercortisolemia after surgery and/or radiation for Cushing's syndrome, to bridge the period of time for radiation to become effective, or when surgery is not feasible.
Current Primary Outcome:
- Improvement in Diabetes and/or Glucose Intolerance. [ Time Frame: Baseline to Week 24 ]
Responder is defined as subject with a decrease greater than or equal to 25% in area under the curve for glucose on 2-hour oral glucose test from baseline to week 24 or last visit, for Cushing's patients with type-2 diabetes mellitus/impaired glucose tolerance.
- Decrease in Diastolic Blood Pressure. [ Time Frame: Baseline to Week 24 ]
Responder is defined as subject with a decrease greater than or equal to 5mm Hg in diastolic blood pressure from baseline to week 24 or last visit.
Original Primary Outcome: Improvement in diabetes and/or glucose intolerance and/or hypertension and; drug safety. [ Time Frame: 24 weeks ]
Current Secondary Outcome:
Original Secondary Outcome: Improvement in other symptoms of Cushing's Syndrome. [ Time Frame: 30 weeks ]
Information By: Corcept Therapeutics
Date Received: December 5, 2007
Date Started: December 2007
Last Updated: August 12, 2013
Last Verified: August 2013