Chief Cushie ~MaryO~ Posted May 4, 2008 Chief Cushie Report Share Posted May 4, 2008 http://www.cushingsstudy.com/index.php/questionnaire 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 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 firstname.lastname@example.org 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. Link to comment Share on other sites More sharing options...
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