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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Corcept Therapeutics
ClinicalTrials.gov Identifier:
NCT01371565
First received: June 7, 2011
Last updated: February 19, 2014
Last verified: February 2014
Results First Received: September 19, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Cushing's Disease
Cushing's Syndrome
Intervention: Drug: Mifepristone

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Eligible patients were men or non-pregnant women 18 yrs or older requiring medical treatment for symptoms of endogenous Cushing’s syndrome due to ectopic ACTH, adrenal tumors/adrenal hyperplasia, or Cushing’s disease if not candidates for pituitary surgery. Pts w/de novo Cushing’s disease who were candidates for surgery were not enrolled.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All patients received active drug (no placebo).

Reporting Groups
  Description
Mifepristone At doses from 300mg/day up to 1200mg/day

Participant Flow:   Overall Study
    Mifepristone  
STARTED     4  
COMPLETED     1  
NOT COMPLETED     3  
Withdrawal by Subject                 1  
Death                 1  
Resection of neuroendocrine tumor                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects who received one dose of study drug were included in the safety analysis.

Reporting Groups
  Description
Mifepristone At doses from 300mg/day up to 1200mg/day

Baseline Measures
    Mifepristone  
Number of Participants  
[units: participants]
  4  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     3  
>=65 years     1  
Age  
[units: years]
Mean ± Standard Deviation
  44.8  ± 17.9  
Gender  
[units: participants]
 
Female     1  
Male     3  
Region of Enrollment  
[units: participants]
 
United States     4  



  Outcome Measures

1.  Primary:   Number of Participants With Adverse Events   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Medical Director
Organization: Corcept Therapeutics
phone: 650-327-3270
e-mail: info@corcept.com


No publications provided


Responsible Party: Corcept Therapeutics
ClinicalTrials.gov Identifier: NCT01371565     History of Changes
Other Study ID Numbers: C1073-405
Study First Received: June 7, 2011
Results First Received: September 19, 2013
Last Updated: February 19, 2014
Health Authority: United States: Food and Drug Administration