Compassionate Use of CORLUX® (Mifepristone) in the Treatment of Signs and Symptoms of Endogenous Cushing's Syndrome
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
First received: June 7, 2011
Last updated: September 4, 2012
Last verified: October 2011
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.
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Compassionate Use Protocol for the Administration of CORLUX® (Mifepristone) in the Treatment of the Signs and Symptoms of Endogenous Cushing's Syndrome
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Subjects who have received at least 1 dose of mifepristone will be included in the safety evaluations. Safety will be evaluated by:
- Periodic physical examinations and evaluation of vital signs
- Assessment of adverse events
- Periodic laboratory evaluations including hematology, electrolytes, liver function, lipid tests
- Radiographic Procedures (transvaginal ultrasound in women with intact uterus and pituitary MRI in subjects with Cushing's Disease)
| Estimated Enrollment:
| Study Start Date:
| Estimated Primary Completion Date:
||October 2012 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Have a confirmed diagnosis of endogenous hypercortisolemia caused by ACTH dependent or ACTH independent etiologies including:
- Have documented biochemical evidence of endogenous hypercortisolemia which includes elevated urinary free cortisol.
- Require medical treatment of hypercortisolemia.
Individuals not eligible to be enrolled into the study are those who:
- Have de novo Cushing's disease and are surgical candidates for pituitary surgery.
- Have an acute or unstable medical problem, which could be aggravated by mifepristone treatment.
- Taking medications within 14 days of the baseline visit (Day 1) that a) have a large first pass metabolism largely mediated by CYP3A4 and 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) within 30 days of Screening
- Have a history of an allergic reaction or intolerance to CORLUX (mifepristone)
- Have a non-endogenous source of hypercortisolemia such as factious hypercortisolemia (exogenous source of glucocorticoid, iatrogenic Cushing's syndrome), factious or therapeutic use of ACTH
- Have Pseudo-Cushing's syndrome.
- Postmenopausal women with an intact uterus who have experienced unexplained vaginal bleeding within 12 months of Screening are excluded.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01371565
|The Center for Diabetes and Endocrine Care
|Hollywood, Florida, United States, 33021 |
|Sinai Hospital of Baltimore
|Baltimore, Maryland, United States, 21215 |
|University of Michigan Medical Center
|Ann Arbor, Michigan, United States, 48109 |
|Cleveland Clinic Foundation
|Cleveland, Ohio, United States, 44195 |
|The Ohio State University, Division of Endocrinology Diabetes and Metabolism
|Columbus, Ohio, United States, 43210 |
||Coleman Gross, M.D.
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 7, 2011
||September 4, 2012
||United States: Food and Drug Administration
Keywords provided by Corcept Therapeutics:
Ectopic ACTH secretion
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on June 18, 2013
Pituitary ACTH Hypersecretion
Signs and Symptoms
Adrenal Gland Diseases
Endocrine System Diseases
Central Nervous System Diseases
Nervous System Diseases
Contraceptives, Oral, Synthetic
Contraceptive Agents, Female
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Postcoital, Synthetic
Hormones, Hormone Substitutes, and Hormone Antagonists
Abortifacient Agents, Steroidal