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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00936741
Recruitment Status : Completed
First Posted : July 10, 2009
Results First Posted : April 2, 2014
Last Update Posted : April 2, 2014
Information provided by (Responsible Party):
Corcept Therapeutics

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.

Condition or disease Intervention/treatment Phase
Cushing's Syndrome Drug: mifepristone Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : July 2009
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Arm Intervention/treatment
Experimental: Mifepristone
Mifepristone 300mg to 1200mg once daily
Drug: mifepristone
Mifepristone 300 mg to 1200 mg once daily
Other Name: CORLUX

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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)".

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Have completed the Week 24 visit and the 6-Week Follow-up visit of Corcept Study C-1073-400 (NCT00569582).
  • In the opinion of the Investigator, are expected to maintain clinical benefit from mifepristone.
  • Women of childbearing potential have a negative serum pregnancy test at Entry.
  • Women of childbearing potential must be willing to use non-hormonal, medically acceptable methods of contraception during the study.
  • Are able to provide written informed consent
  • Are able to return to the investigative site to complete the study evaluations outlined in the protocol.
  • Will not use systemic estrogens during the study.

Exclusion Criteria:

  • Have an acute or unstable medical problem, which could be aggravated by mifepristone treatment.
  • Are taking medications within 14 days of the Entry visit that a) have a large first pass metabolism that is largely mediated by CYP3A4 and which have a narrow therapeutic margin; and/or b) are strong CYP3A4 inhibitors.
  • Female patients of reproductive potential, who are pregnant or who are unable or unwilling to use medically acceptable, non-hormonal methods of contraception during the study.
  • Have received investigational treatment (drug, biological agent or device) other than CORLUX (mifepristone) within 30 days of Entry
  • Have a history of an allergic reaction or intolerance to CORLUX (mifepristone)
  • Have uncorrected hypokalemia (potassium level of <3.5 mEq/L) at Entry. Spironolactone or eplerenone is allowed to control hypokalemia.
  • Postmenopausal women with a history of endometrial hyperplasia with atypia or pathological features consistent with endometrial carcinoma.
  • Thickened endometrium on the Entry Visit transvaginal ultrasound that has not resolved after induction of menstrual bleeding with progesterone.
  • Uncontrolled, clinically significant hypothyroidism or hyperthyroidism.
  • Any woman with an intact uterus who has a hemorrhagic disorder or is being treated with an anticoagulant (e.g. warfarin, heparin).
  • Have renal failure as defined by a serum creatinine of ≥2.2 mg/dL.
  • Elevated total bilirubin >1.5 ULN, elevated ALT or AST ≥3X the upper limit of normal.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00936741

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United States, Alabama
University of Alabama at Birmingham School of Medicine
Birmingham, Alabama, United States, 35294
United States, California
AMCR Institute Inc.
Escondido, California, United States, 92026
Stanford University Medical Center
Stanford, California, United States, 94305-5826
United States, Florida
The Center for Diabetes and Endocrine Care
Hollywood, Florida, United States, 33021
United States, Illinois
Northwestern University Feinberg Medical; Division of Endocrinology, Metabolism & Molecular Medicine
Chicago, Illinois, United States, 60611
United States, Maryland
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Michigan
University of Michigan Medical Center
Ann Arbor, Michigan, United States, 48109
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87131
United States, Ohio
Cleveland Clinic Foundation; Dept of Endocrinology, Diabetes & Metabolism
Cleveland, Ohio, United States, 44195
United States, Oklahoma
Oklahoma Diabetes Center
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Oregon Health Sciences University
Portland, Oregon, United States, 97239
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390-8857
United States, Wisconsin
Endocrinology Center at Community Medical Commons
Menomonee Falls, Wisconsin, United States, 53051
Sponsors and Collaborators
Corcept Therapeutics
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Study Director: Coleman Gross, MD Corcept Therapeutics
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Corcept Therapeutics Identifier: NCT00936741    
Other Study ID Numbers: C-1073-415
First Posted: July 10, 2009    Key Record Dates
Results First Posted: April 2, 2014
Last Update Posted: April 2, 2014
Last Verified: February 2014
Keywords provided by Corcept Therapeutics:
Cushing's Disease
Cushing's Syndrome
Adrenocorticotropic hormone
Adrenal adenoma
Adrenal carcinoma
Adrenal autonomy
Moon facies
Dorsocervical fat
Violaceous striae
Cushing Syndrome
Ectopic ACTH Secretion
Additional relevant MeSH terms:
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Cushing Syndrome
Pathologic Processes
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases
Abortifacient Agents, Steroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Contraceptive Agents, Hormonal
Menstruation-Inducing Agents