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

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ClinicalTrials.gov Identifier: NCT00936741

Recruitment Status : Completed

First Posted : July 10, 2009

Results First Posted : April 2, 2014

Last Update Posted : April 2, 2014

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Sponsor:

Information provided by (Responsible Party):

Corcept Therapeutics

Study Type	Interventional
Study Design	Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition	Cushing's Syndrome
Intervention	Drug: mifepristone
Enrollment	30

Participant Flow

Recruitment Details	Subjects completing 24 weeks of mifepristone treatment under Corcept protocol C1073-400 (NCT00569582) were eligible to continue treatment in C1073-415 at the dose being administered at the end of treatment in C1073-400 (NCT00569582).
Pre-assignment Details	Only subjects who had completed C1073-400 (NCT00569582) were enrolled. All subjects received active drug (no placebo).


Arm/Group Title	Open-label
Arm/Group Description	mifepristone at doses from 300 mg/d...
Arm/Group Description	mifepristone at doses from 300 mg/day up to 1200 mg/day daily
Period Title: Overall Study
Started	30
Completed	21
Not Completed	9

Baseline Characteristics

Arm/Group Title		Open-label
Arm/Group Description		mifepristone at doses from 300 mg/d...
Arm/Group Description		mifepristone at doses from 300 mg/day up to 1200 mg/day daily
Overall Number of Baseline Participants		30
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Categorical Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	30 participants
	<=18 years	0 0.0%
	Between 18 and 65 years	27 90.0%
	>=65 years	3 10.0%
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	30 participants
		46.1 (11.74)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	30 participants
	Female	20 66.7%
	Male	10 33.3%
Region of Enrollment Measure Type: Number Unit of measure: Participants
United States	Number Analyzed	30 participants
United States		30

Outcome Measures

1.Primary Outcome


Title	Number of Participants With Adverse Events
Description	Subjects who received at least one dose of mifepristone were included ...
Description	Subjects who received at least one dose of mifepristone were included in the safety analysis.
Time Frame	Up to three years.

Outcome Measure Data

Analysis Population Description

Subjects who received one dose of study drug were included in the safety and ITT analyses.


Arm/Group Title	Open-label
Arm/Group Description:	mifepristone at doses from 300 mg/d...
Arm/Group Description:	mifepristone at doses from 300 mg/day up to 1200 mg/day daily
Overall Number of Participants Analyzed	30
Measure Type: Number Unit of Measure: participants
	30

2.Secondary Outcome


Title	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
Description	The mean Investigator's rating of the change in subject's signs and sy...
Description	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)".
Time Frame	Up to three years.

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Open-label
Arm/Group Description:	mifepristone at doses from 300 mg/d...
Arm/Group Description:	mifepristone at doses from 300 mg/day up to 1200 mg/day daily
Overall Number of Participants Analyzed	30
Mean (Standard Deviation) Unit of Measure: units on a scale
	3.3 (1.74)

Adverse Events

Time Frame	up to 36 months from entry.
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	Mifepristone 300 to 1200 mg Daily
Arm/Group Description	mifepristone at doses from 300 mg/d...
Arm/Group Description	mifepristone at doses from 300 mg/day to 1200 mg/day
All-Cause Mortality
	Mifepristone 300 to 1200 mg Daily
	Affected / at Risk (%)
Total	--/--
Serious Adverse Events Serious Adverse Events
	Mifepristone 300 to 1200 mg Daily
	Affected / at Risk (%)	# Events
Total	18/30 (60.00%)
Cardiac disorders
Pericarditis ^† 1	1/30 (3.33%)	1
Endocrine disorders
Adrenal Insufficiency ^† 1	2/30 (6.67%)	2
Gastrointestinal disorders
Small intestinal obstruction ^† 1	1/30 (3.33%)	1
Immune system disorders
Amyloidosis ^† 1	1/30 (3.33%)	1
Infections and infestations
Pneumonia ^† 1	2/30 (6.67%)	2
Arthritis Bacterial ^† 1	1/30 (3.33%)	1
Gastroenteritis ^† 1	1/30 (3.33%)	1
Groin abscess ^† 1	1/30 (3.33%)	1
Subcutaneous abscess ^† 1	1/30 (3.33%)	1
Injury, poisoning and procedural complications
Hip Fracture ^† 1	1/30 (3.33%)	1
Investigations
Blood Postassium Decreased ^† 1	4/30 (13.33%)	4
Metabolism and nutrition disorders
Hyperglycemia ^† 1	1/30 (3.33%)	1
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain ^† 1	1/30 (3.33%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma ^† 1	1/30 (3.33%)	1
Malignant melanoma in situ ^† 1	1/30 (3.33%)	1
Oesophageal carcinoma ^† 1	1/30 (3.33%)	1
Uterine leiomyoma ^† 1	1/30 (3.33%)	1
Nervous system disorders
Amnesia ^† 1	1/30 (3.33%)	1
Cerebral infarction ^† 1	1/30 (3.33%)	1
Cerebrovascular accident ^† 1	1/30 (3.33%)	1
Psychiatric disorders
Anxiety ^† 1	1/30 (3.33%)	1
Renal and urinary disorders
Nephrolithiasis ^† 1	1/30 (3.33%)	1
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease ^† 1	1/30 (3.33%)	1
Dyspnoea ^† 1	1/30 (3.33%)	1
Interstitial lung disease ^† 1	1/30 (3.33%)	1
Respiratory Failure ^† 1	1/30 (3.33%)	1
Vascular disorders
Hypertensive crisis ^† 1	1/30 (3.33%)	1
† Indicates events were collected by systematic assessment 1 Term from vocabulary, MedDRA (10.0)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Mifepristone 300 to 1200 mg Daily
	Affected / at Risk (%)	# Events
Total	30/30 (100.00%)
Blood and lymphatic system disorders
Anaemia ^† 1	2/30 (6.67%)	2
Pancytopenia ^† 1	2/30 (6.67%)	2
Cardiac disorders
Atrioventricular block first degree ^† 1	2/30 (6.67%)	2
Sinus bradycardia ^† 1	4/30 (13.33%)	6
Tachycadia ^† 1	3/30 (10.00%)	3
Endocrine disorders
Adrenal insufficiency ^† 1	3/30 (10.00%)	3
Cushing's syndrome ^† 1	2/30 (6.67%)	2
Gynaecomastia ^† 1	3/30 (10.00%)	3
Hypothyroidism ^† 1	3/30 (10.00%)	3
Eye disorders
Cataract nuclear ^† 1	2/30 (6.67%)	3
Diplopia ^† 1	2/30 (6.67%)	2
Vision blurred ^† 1	2/30 (6.67%)	3
Gastrointestinal disorders
Abdominal pain upper ^† 1	5/30 (16.67%)	6
Nausea ^† 1	15/30 (50.00%)	29
Vomiting ^† 1	7/30 (23.33%)	14
Abdominal discomfort ^† 1	2/30 (6.67%)	2
Abdominal distension ^† 1	2/30 (6.67%)	2
Abdominal pain ^† 1	3/30 (10.00%)	3
Constipation ^† 1	3/30 (10.00%)	3
Diarrhoea ^† 1	3/30 (10.00%)	4
Toothache ^† 1	2/30 (6.67%)	2
General disorders
Fatique ^† 1	12/30 (40.00%)	14
Oedema peripheral ^† 1	7/30 (23.33%)	10
Chest pain ^† 1	2/30 (6.67%)	4
Infections and infestations
Nasopharyngitis ^† 1	6/30 (20.00%)	7
Upper respiratory tract infection ^† 1	6/30 (20.00%)	7
Pneumonia ^† 1	3/30 (10.00%)	3
Sinusitis ^† 1	2/30 (6.67%)	2
Urinary tract infection ^† 1	4/30 (13.33%)	7
Vulvovaginal mycotic infection ^† 1	3/30 (10.00%)	3
Injury, poisoning and procedural complications
Contusion ^† 1	3/30 (10.00%)	3
Skin laceration ^† 1	2/30 (6.67%)	2
Investigations
Blood potassium decreased ^† 1	14/30 (46.67%)	46
Thyroid function test abnormal ^† 1	6/30 (20.00%)	6
Androgens increased ^† 1	2/30 (6.67%)	3
Blood cholesterol increased ^† 1	4/30 (13.33%)	4
Blood corticotrophin increased ^† 1	2/30 (6.67%)	2
Blood creatinine increased ^† 1	2/30 (6.67%)	2
Blood potassium increased ^† 1	2/30 (6.67%)	3
Blood testosterone free increased ^† 1	3/30 (10.00%)	4
Blood testosterone increased ^† 1	3/30 (10.00%)	3
Electrocardiogram QT prolonged ^† 1	3/30 (10.00%)	3
Protein urine ^† 1	2/30 (6.67%)	2
Urine cortisol / creatinine ratio increased ^† 1	2/30 (6.67%)	3
White blood cell count increased ^† 1	2/30 (6.67%)	2
Metabolism and nutrition disorders
Decreased appetite ^† 1	3/30 (10.00%)	4
Dyslipidaemia ^† 1	2/30 (6.67%)	2
Hypoglycaemia ^† 1	3/30 (10.00%)	4
Vitamin D deficiency ^† 1	2/30 (6.67%)	2
Musculoskeletal and connective tissue disorders
Arthralgia ^† 1	2/30 (6.67%)	3
Back pain ^† 1	5/30 (16.67%)	5
Joint swelling ^† 1	2/30 (6.67%)	3
Muscle spasms ^† 1	3/30 (10.00%)	4
Musculoskeletal chest pain ^† 1	2/30 (6.67%)	5
Musculoskeletal pain ^† 1	4/30 (13.33%)	5
Myalgia ^† 1	2/30 (6.67%)	2
Osteopenia ^† 1	2/30 (6.67%)	2
Osteoporosis ^† 1	2/30 (6.67%)	2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumor benign ^† 1	3/30 (10.00%)	4
Uterine leiomyoma ^† 1	2/30 (6.67%)	2
Nervous system disorders
Headache ^† 1	11/30 (36.67%)	22
Dizziness ^† 1	7/30 (23.33%)	9
Muscular weakness ^† 1	2/30 (6.67%)	3
Psychiatric disorders
Anxiety ^† 1	3/30 (10.00%)	3
Depression ^† 1	3/30 (10.00%)	5
Insomnia ^† 1	4/30 (13.33%)	4
Panic attack ^† 1	2/30 (6.67%)	2
Sleep disorder ^† 1	2/30 (6.67%)	3
Renal and urinary disorders
Nephrolithiasis ^† 1	3/30 (10.00%)	3
Pollakiuria ^† 1	2/30 (6.67%)	2
Reproductive system and breast disorders
Endometrial disorder ^† 1	4/30 (13.33%)	7
Endometrial hypertrophy ^† 1	10/30 (33.33%)	12
Metrorrhagia ^† 1	4/30 (13.33%)	5
Ovarian cyst ^† 1	2/30 (6.67%)	4
Vaginal haemorrhage ^† 1	4/30 (13.33%)	8
Respiratory, thoracic and mediastinal disorders
Cough ^† 1	3/30 (10.00%)	4
Dyspnoea ^† 1	2/30 (6.67%)	4
Pharyngolaryngeal pain ^† 1	2/30 (6.67%)	3
Skin and subcutaneous tissue disorders
Skin discolouration ^† 1	2/30 (6.67%)	2
Vascular disorders
Hot flush ^† 1	2/30 (6.67%)	2
Hypertension ^† 1	9/30 (30.00%)	14
Hypotension ^† 1	2/30 (6.67%)	3
† Indicates events were collected by systematic assessment 1 Term from vocabulary, MedDRA (10.0)

Limitations and Caveats

[Not Specified]

More Information

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.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Medical Director
Organization:	Corcept Therapeutics
Phone:	650-327-3270
EMail:	info@corcept.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Fein HG, Vaughan TB 3rd, Kushner H, Cram D, Nguyen D. Sustained weight loss in patients treated with mifepristone for Cushing's syndrome: a follow-up analysis of the SEISMIC study and long-term extension. BMC Endocr Disord. 2015 Oct 27;15:63. doi: 10.1186/s12902-015-0059-5.

Fleseriu M, Findling JW, Koch CA, Schlaffer SM, Buchfelder M, Gross C. Changes in plasma ACTH levels and corticotroph tumor size in patients with Cushing's disease during long-term treatment with the glucocorticoid receptor antagonist mifepristone. J Clin Endocrinol Metab. 2014 Oct;99(10):3718-27. doi: 10.1210/jc.2014-1843. Epub 2014 Jul 11.

Layout table for additonal information

Responsible Party:	Corcept Therapeutics
ClinicalTrials.gov Identifier:	NCT00936741
Other Study ID Numbers:	C-1073-415
First Submitted:	July 9, 2009
First Posted:	July 10, 2009
Results First Submitted:	September 18, 2013
Results First Posted:	April 2, 2014
Last Update Posted:	April 2, 2014

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