Breaking ground in Cushing’s research with...
"An Open Label Study of the Efficacy and Safety of CORLUX (mifepristone) in the Treatment of the Signs and Symptoms of Endogenous Cushing’s Syndrome"
The SEISMIC Study is a US based clinical research trial designed to test mifepristone in the treatment of the clinical manifestations of endogenous Cushing’s Syndrome over a 6 month period of treatment
Patients: Take the questionnaire Physicians/health care providers: View the Inclusion and Exclusion Criteria - Click Again to close SEISMIC Study- Main Inclusion Criteria Subjects must: | Be at least 18 years of age | Have a confirmed diagnosis of endogenous hypercortisolemia caused by ACTH dependent or ACTH independent etiologies, including: a. Cushing’s Disease that
| | i. | recurred after primary pituitary surgery or | | | ii. | has persisted despite pituitary surgery (failed pituitary surgery) or | | | iii. | has been treated with radiation therapy to the pituitary | | | iv. | is not treatable with surgery | | | v. | exists in patients who are not candidates for surgery |
b. Ectopic ACTH c. Ectopic CRF secretion d. Adrenal adenoma e. Adrenal carcinoma f. Adrenal autonomy
| Require medical treatment of hypercortisolemia | Have diabetes mellitus type 2 or glucose intolerance AND/OR have hypertension caused by, or aggravated by hypercortisolemia | Have two or more of the following signs or symptoms related to hypercortisolemia: • Cushinoid appearance • Increased body weight or central obesity • Proximal muscle weakness • Low bone mass (DXA T < -1.0) • Psychiatric symptoms (including depression or psychosis) • Hirsutism and/or violaceous striae and/or acne
|
SEISMIC Study- Main Exclusion Criteria Subjects must not: | Have de novo Cushing’s disease or be surgical candidates for pituitary surgery | Have an acute or unstable medical problem, which could be aggravated by mifepristone treatment | Be currently taking medications known to significantly induce or inhibit CYP3A4, or have taken these medications within 7 days of Screening | Be pregnant or unable or unwilling to use medically acceptable, non-hormonal methods of contraception during the study (female patients of reproductive potential) | 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 | Receive PPARg agonist drugs (e.g. pioglitazone, rosiglitazone) within 4 months of screening | Have renal failure as defined by a serum creatinine of ≥2.2 mg/dL | Be a postmenopausal woman with an intact uterus who has experienced unexplained vaginal bleeding within 12 months of Screening |
For more information about the SEISMIC Study, please email us at
This e-mail address is being protected from spambots, you need JavaScript enabled to view it
or call 1 877-367-6550
Mifepristone is under investigation for Cushing’s Syndrome. It has not been approved by the US FDA for treatment of Cushing’s Syndrome.
|
