Skip to content

Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

NCTNCT00936741 (opens ClinicalTrials.gov in a new tab)Other idC-1073-415
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Names ACTH (corticotropin), does not test it. It appears in the conditions.

Overview

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

United States

Start
Jul 2009
Primary completion
Sept 2012
Completion
Sept 2012
First posted
10 Jul 2009 (estimated)
Last update posted
2 Apr 2014 (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
20092010201120122013
  1. Ph 3

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

    NCT00936741

    Jul 2009 to Sept 2012

Registry summary

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

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.

Interventions

  • mifepristoneDrug

Arms1

  • Experimental

    Mifepristone

    Mifepristone 300mg to 1200mg once daily

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Number of Participants With Adverse Events

    Time frame · Up to three years.

    Registry description

    Subjects who received at least one dose of mifepristone were included in the safety analysis.

Secondary outcomes(1)

  1. 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

    Time frame · Up to three years.

    Registry 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)".

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· Up to three years.

Number of Participants With Adverse Events

GroupValue (participants)
Open-label30
Secondary and other outcome results(1)
Secondary outcomeMean· Up to three years.

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

GroupValue (units on a scale)Spread
Open-label3.31.74

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Mifepristone 300 to 1200 mg Dailymifepristone at doses from 300 mg/day to 1200 mg/day–18 / 3030 / 30

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.

  • 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

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Have completed the Week 24 visit and the 6-Week Follow-up visit of Corcept Study C-1073-400 (NCT00569582). * In the opinion of the Investigator, are expected to maintain clinical benefit from mifepristone. * Women of childbearing potential have a negative serum pregnancy test at Entry. * Women of childbearing potential must be willing to use non-hormonal, medically acceptable methods of contraception during the study. * Are able to provide written informed consent * Are able to return to the investigative site to complete the study evaluations outlined in the protocol. * Will not use systemic estrogens during the study. Exclusion Criteria: * Have an acute or unstable medical problem, which could be aggravated by mifepristone treatment. * Are taking medications within 14 days of the Entry visit that a) have a large first pass metabolism that is largely mediated by CYP3A4 and which have 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) other than CORLUX (mifepristone) within 30 days of Entry * Have a history of an allergic reaction or intolerance to CORLUX (mifepristone) * Have uncorrected hypokalemia (potassium level of \<3.5 mEq/L) at Entry. Spironolactone or eplerenone is allowed to control hypokalemia. * Postmenopausal women with a history of endometrial hyperplasia with atypia or pathological features consistent with endometrial carcinoma. * Thickened endometrium on the Entry Visit transvaginal ultrasound that has not resolved after induction of menstrual bleeding with progesterone. * Uncontrolled, clinically significant hypothyroidism or hyperthyroidism. * Any woman with an intact uterus who has a hemorrhagic disorder or is being treated with an anticoagulant (e.g. warfarin, heparin). * Have renal failure as defined by a serum creatinine of ≥2.2 mg/dL. * Elevated total bilirubin \>1.5 ULN, elevated ALT or AST ≥3X the upper limit of normal.

PepBank is a research reference. Talk to a doctor before you use any peptide.