Cushing's Syndrome Clinical Trial
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
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.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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