NCT00936741

An Extension Study of CORLUX in the Treatment of Endogenous Cushing's Syndrome

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Corcept Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Cushing's Syndrome

Interventions

Type	Name	Description
DRUG	mifepristone	Mifepristone 300 mg to 1200 mg once daily

Timeline

• Start date: 2009-07-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2009-07-10
• Last updated: 2014-04-02
• Results posted: 2014-04-02

Locations

15 sites across 1 country: United States