Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mifepristone | Experimental | Mifepristone 300mg to 1200mg once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mifepristone | Drug | Mifepristone 300 mg to 1200 mg once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | Subjects who received at least one dose of mifepristone were included in the safety analysis. | Up to three years. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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)". |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Coleman Gross, MD | Corcept Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham School of Medicine | Birmingham | Alabama | 35294 | United States | ||
| AMCR Institute Inc. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26507877 | Derived | 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. | |
| 25013998 | Derived | 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. |
| Label | URL |
|---|---|
| Corcept C-1073-400 Clinicaltrials.gov Study Listing | View source |
Not provided
Only subjects who had completed C1073-400 (NCT00569582) were enrolled. All subjects received active drug (no placebo).
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).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Open-label | mifepristone at doses from 300 mg/day up to 1200 mg/day daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Up to three years. |
| Escondido |
| California |
| 92026 |
| United States |
| Stanford University Medical Center | Stanford | California | 94305-5826 | United States |
| The Center for Diabetes and Endocrine Care | Hollywood | Florida | 33021 | United States |
| Northwestern University Feinberg Medical; Division of Endocrinology, Metabolism & Molecular Medicine | Chicago | Illinois | 60611 | United States |
| Sinai Hospital of Baltimore | Baltimore | Maryland | 21215 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| University of Michigan Medical Center | Ann Arbor | Michigan | 48109 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
| University of New Mexico | Albuquerque | New Mexico | 87131 | United States |
| Cleveland Clinic Foundation; Dept of Endocrinology, Diabetes & Metabolism | Cleveland | Ohio | 44195 | United States |
| Oklahoma Diabetes Center | Oklahoma City | Oklahoma | 73104 | United States |
| Oregon Health Sciences University | Portland | Oregon | 97239 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390-8857 | United States |
| Endocrinology Center at Community Medical Commons | Menomonee Falls | Wisconsin | 53051 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Open-label | mifepristone at doses from 300 mg/day up to 1200 mg/day daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events | Subjects who received at least one dose of mifepristone were included in the safety analysis. | Subjects who received one dose of study drug were included in the safety and ITT analyses. | Posted | Number | participants | Up to three years. |
|
|
| ||||||||||||||||||||||||||
| Secondary | 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 | 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)". | Posted | Mean | Standard Deviation | units on a scale | Up to three years. |
|
|
up to 36 months from entry.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mifepristone 300 to 1200 mg Daily | mifepristone at doses from 300 mg/day to 1200 mg/day | 18 | 30 | 30 | 30 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pericarditis | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Adrenal Insufficiency | Endocrine disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Amyloidosis | Immune system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Arthritis Bacterial | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Groin abscess | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Hip Fracture | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
| |
| Blood Postassium Decreased | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
| |
| Malignant melanoma in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
| |
| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
| |
| Amnesia | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adrenal insufficiency | Endocrine disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Fatique | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Thyroid function test abnormal | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Atrioventricular block first degree | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Tachycadia | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Cushing's syndrome | Endocrine disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Gynaecomastia | Endocrine disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Cataract nuclear | Eye disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
| |
| Androgens increased | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Blood corticotrophin increased | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Blood potassium increased | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Blood testosterone free increased | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Blood testosterone increased | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Protein urine | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Urine cortisol / creatinine ratio increased | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Osteopenia | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Pituitary tumor benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
| |
| Muscular weakness | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Panic attack | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Endometrial disorder | Reproductive system and breast disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Endometrial hypertrophy | Reproductive system and breast disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Metrorrhagia | Reproductive system and breast disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Corcept Therapeutics | 650-327-3270 | info@corcept.com |
| ID | Term |
|---|---|
| D003480 | Cushing Syndrome |
| D047748 | Pituitary ACTH Hypersecretion |
| D010900 | Pituitary Diseases |
| D002828 | Choristoma |
| D000182 | ACTH Syndrome, Ectopic |
| D000306 | Adrenal Cortex Neoplasms |
| D006628 | Hirsutism |
| ID | Term |
|---|---|
| D000308 | Adrenocortical Hyperfunction |
| D000307 | Adrenal Gland Diseases |
| D004700 | Endocrine System Diseases |
| D006964 | Hyperpituitarism |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009384 | Paraneoplastic Endocrine Syndromes |
| D010257 | Paraneoplastic Syndromes |
| D009369 | Neoplasms |
| D000310 | Adrenal Gland Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D000303 | Adrenal Cortex Diseases |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D014770 | Virilism |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D015735 | Mifepristone |
| C511997 | Corlux |
| ID | Term |
|---|---|
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
|