Clinical Trial: An Extension Study of CORLUX in the Treatment of Endogenous Cushing's Syndrome
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: An Open Label Extension Study of the Efficacy and Safety of CORLUX® (Mifepristone) in the Treatment of the Signs and Symptoms of Endogenous Cushing's Syndrome
Brief 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.
Detailed Summary: Up to 50 subjects will receive mifepristone daily. Subjects completing 24 weeks of mifepristone treatment under Corcept protocol C1073-400 (NCT00569582) will be eligible to continue treatment for an additional 1 year. Assessments of safety, as evaluated by physical examinations, vital signs, laboratory tests and adverse events, will be made. Persistence of improvement in response to mifepristone treatment will also be evaluated during this extension study by assessing the continued or sustained improvement in the signs and symptoms of Cushing's syndrome.
Sponsor: Corcept Therapeutics
Current Primary Outcome: Number of Participants With Adverse Events [ Time Frame: Up to three years. ]
Subjects who received at least one dose of mifepristone were included in the safety analysis.
Original Primary Outcome: Long term safety of mifepristone treatment [ Time Frame: 12 months ]
Current Secondary Outcome: 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 [ Time Frame: Up to three years. ]
The mean Investigator's rating of the change in subject's signs and symptoms of Cushing's syndrome from Baseline (Entry into C1073-415) to Endpoint on the Physician's Global Assessment of Disease Severity was ranked on a 9-point scale (9 = much worse, 7 = worse, 5 = no change, 3 = better, 1 = much better). Higher scores indicate more severe illness. Scoring was done at all visits except the 6 Week Follow-up visit; the final visit result (Endpoint) is reported here.
The instruction was "Rate the change in the subject's signs and symptoms of Cushing's from Baseline (1 = much better to 9 = much worse)".
Original Secondary Outcome: Persistence of therapeutic benefit due to continued mifepristone treatment [ Time Frame: 12 months ]
Information By: Corcept Therapeutics
Date Received: July 9, 2009
Date Started: July 2009
Last Updated: February 19, 2014
Last Verified: February 2014