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Trial · Interventional

CompletedPhase 3Results postedRegistry data

A Study of the Efficacy and Safety of CORLUX in the Treatment of Endogenous Cushing's Syndrome

Short name SEISMIC

This trial does not test a peptide that PepBank tracks.

  • Measures ACTH (corticotropin), does not give it. It appears in the eligibility rules.

Overview

Status
Completed
Phase
Phase 3
Enrollment
50 participants (actual)
Sponsor
Corcept Therapeutics · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
Dec 2007
Primary completion
Jan 2011
Completion
Not stated
First posted
7 Dec 2007 (estimated)
Last update posted
22 Aug 2013 (estimated)
Conditions
Cushing's Syndrome

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200720082009201020112012
  1. Ph 3

    SEISMIC

    NCT00569582

    Dec 2007 to Jan 2011 (primary)

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Patients will receive Corlux (mifepristone) daily for up to 24 weeks. Assessments of the signs and symptoms of Cushing's syndrome will be obtained.

Interventions

  • mifepristoneDrug

Arms1

  • Experimental

    1

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Improvement in Diabetes and/or Glucose Intolerance.

    Time frame · Baseline to Week 24

    Registry description

    Responder is defined as subject with a decrease greater than or equal to 25% in area under the curve for glucose on 2-hour oral glucose test from baseline to week 24 or last visit, for Cushing's patients with type-2 diabetes mellitus/impaired glucose tolerance.

  2. Decrease in Diastolic Blood Pressure.

    Time frame · Baseline to Week 24

    Registry description

    Responder is defined as subject with a decrease greater than or equal to 5mm Hg in diastolic blood pressure from baseline to week 24 or last visit.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· Baseline to Week 24

Improvement in Diabetes and/or Glucose Intolerance.

GroupValue (participants)
Mifepristone15
Primary outcomeNumber· Baseline to Week 24

Decrease in Diastolic Blood Pressure.

GroupValue (participants)
Mifepristone8

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
MifepristoneMifepristone was administered at doses of 300-1200 mg daily.–16 / 5049 / 50

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • ResultFleseriu M, Biller BM, Findling JW, Molitch ME, Schteingart DE, Gross C; SEISMIC Study Investigators. Mifepristone, a glucocorticoid receptor antagonist, produces clinical and metabolic benefits in patients with Cushing's syndrome. J Clin Endocrinol Metab. 2012 Jun;97(6):2039-49. doi: 10.1210/jc.2011-3350. Epub 2012 Mar 30. PMID 22466348
  • DerivedFein 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. PMID 26507877
  • DerivedFleseriu 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. PMID 25013998
  • DerivedWallia A, Colleran K, Purnell JQ, Gross C, Molitch ME. Improvement in insulin sensitivity during mifepristone treatment of Cushing syndrome: early and late effects. Diabetes Care. 2013 Sep;36(9):e147-8. doi: 10.2337/dc13-0246. No abstract available. PMID 23970725

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: Individuals eligible for enrollment into this study are adult male and non-pregnant female adult patients who: * Are at least 18 years of age * Have a confirmed diagnosis of endogenous hypercortisolemia caused by ACTH dependent or ACTH independent etiologies, including 1. Cushing's Disease (that has recurred after primary pituitary surgery, or has failed pituitary surgery, or has been treated with radiation therapy to the pituitary, or is not treatable with surgery, or exists in patients who are not candidates for surgery, and is confirmed by documentation of ACTH immuno-reactivity on a pathological evaluation of pituitary tissue from a previous surgical specimen or IPSS with a central-to-peripheral gradient (ratio) of \>2 before or \>3 after CRH administration). 2. Ectopic ACTH 3. Ectopic CRF secretion 4. Adrenal adenoma 5. Adrenal carcinoma 6. Adrenal autonomy * Require medical treatment of hypercortisolemia * Have diabetes mellitus type 2 or glucose intolerance AND/OR have hypertension \*Note: To be eligible for inclusion subjects must have documented evidence of persistent endogenous hypercortisolemia Exclusion Criteria: 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. * Receive PPARgamma agonist drugs (e.g. pioglitazone, rosiglitazone) within 4 months of Baseline (Day 1). * Postmenopausal women with an intact uterus who have experienced unexplained vaginal bleeding within 12 months of Screening are excluded. * Have renal failure as defined by a serum creatinine of ≥2.2 mg/dL.

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