Clinical Trial: Compassionate Use of CORLUX® (Mifepristone) in the Treatment of Signs and Symptoms of Endogenous Cushing's Syndrome

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Compassionate Use Protocol for the Administration of CORLUX® (Mifepristone) in the Treatment of the Signs and Symptoms of Endogenous Cushing's Syndrome

Brief Summary: This is a compassionate use study. In addition to providing compassionate use access to mifepristone, objectives of the study will be to evaluate the safety and utility of mifepristone in the treatment of the signs and symptoms of endogenous Cushing's syndrome when given on a compassionate use basis. The study will only enroll subjects whose physicians have determined that medical treatment is needed to control the symptoms or signs of hypercortisolemia.

Detailed Summary:
Sponsor: Corcept Therapeutics

Current Primary Outcome: Number of Participants With Adverse Events [ Time Frame: 6 months ]

Safety was assessed at all visits and adverse events were recorded.


Original Primary Outcome: To examine the safety and utility of mifepristone in the treatment of the signs and symptoms of endogenous Cushing's syndrome when given on a compassionate use basis. [ Time Frame: 6 months ]

Subjects who have received at least 1 dose of mifepristone will be included in the safety evaluations. Safety will be evaluated by:

  1. Periodic physical examinations and evaluation of vital signs
  2. Assessment of adverse events
  3. Periodic laboratory evaluations including hematology, electrolytes, liver function, lipid tests
  4. Radiographic Procedures (transvaginal ultrasound in women with intact uterus and pituitary MRI in subjects with Cushing's Disease)


Current Secondary Outcome:

Original Secondary Outcome:

Information By: Corcept Therapeutics

Dates:
Date Received: June 7, 2011
Date Started: November 2010
Date Completion:
Last Updated: February 19, 2014
Last Verified: February 2014