- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03604198
Extension Study to Evaluate the Safety of Long-Term Use of Relacorilant in Patients With Cushing Syndrome
An Open-Label Extension Study of the Safety of Relacorilant in the Treatment of the Signs and Symptoms of Cushing Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study is designed to allow continued therapy with relacorilant, a potent, selective glucocorticoid receptor (GR) antagonist in patients who have successfully completed participation of a Corcept-sponsored study of relacorilant (referred to as the "parent" study). Patients may qualify to enter this extension study if they complete their last treatment visit in their parent study and in the Investigator's opinion will benefit from continued treatment.
Once-daily dosing with relacorilant may continue for patients who receive clinical benefits (as judged by the Investigator) until relacorilant is commercially or otherwise available or the study is stopped by the Sponsor. A patient's dose may be maintained, reduced, or increased based on individual response and tolerability.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Wien, Austria, 1090
- Site 14
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Sofia, Bulgaria, 1431
- Site 15
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Nova Scotia, Canada
- Site 51
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Munich, Germany
- Site 16
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Wuerzburg, Germany, 97080
- Site 42
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Ramat Gan, Israel, 5265601
- Site 20
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Tel Aviv, Israel, 64239
- Site 29
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Ancona, Italy, 60126
- Site 40
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Messina, Italy, 98125
- Site 44
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Milano, Italy, 20145
- Site 25
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Napoli, Italy, 80131
- Site 21
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Padova, Italy, 35128
- Site 48
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Roma, Italy, 00161
- Site 23
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Roma, Italy, 00189
- Site 22
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Torino, Italy
- Site 52
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Rotterdam, Netherlands, 3015 GD
- Site 33
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Kraków, Poland, 30-688
- Site 47
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Lublin, Poland, 20412
- Site 45
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Bucharest, Romania, 11863
- Site 28
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Bucuresti, Romania, 050474
- Site 37
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Bucuresti, Romania, 10825
- Site 31
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Girona, Spain
- Site 18
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Madrid, Spain, 28007
- Site 17
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Málaga, Spain, 29006
- Site 38
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Sevilla, Spain
- Site 19
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Arizona
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Phoenix, Arizona, United States, 85013
- Site 49
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California
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Stanford, California, United States, 94305
- Site 35
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Torrance, California, United States, 90502
- Site 39
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Florida
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Miami, Florida, United States, 33136
- Site 50
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Georgia
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Atlanta, Georgia, United States, 30318
- Site 10
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Illinois
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Chicago, Illinois, United States, 60611
- Site 9
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Indiana
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Indianapolis, Indiana, United States, 46202
- Site 1
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Louisiana
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Metairie, Louisiana, United States, 70006
- Site 5
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Maryland
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Baltimore, Maryland, United States, 21287
- Site 27
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Massachusetts
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Fall River, Massachusetts, United States, 02721
- Site 13
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Michigan
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Ann Arbor, Michigan, United States, 48109
- Site 8
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Minnesota
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Rochester, Minnesota, United States, 55905
- Site 36
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Mississippi
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Jackson, Mississippi, United States, 39202
- Site 34
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New York
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Albany, New York, United States, 12206
- Site 6
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New York, New York, United States, 10021
- Site 24
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North Carolina
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Wilmington, North Carolina, United States, 28401
- Site 4
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Ohio
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Cleveland, Ohio, United States, 44195
- Site 43
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
- Site 41
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- Site 46
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Texas
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Dallas, Texas, United States, 75390
- Site 11
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El Paso, Texas, United States, 79935
- Site 7
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Fort Worth, Texas, United States, 76132
- Site 32
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Houston, Texas, United States, 77079
- Site 12
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Washington
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Spokane, Washington, United States, 99202
- Site 26
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Major Inclusion Criteria:
- Have completed a Corcept-sponsored study of relacorilant in endogenous Cushing syndrome with at least 80% compliance with the dosing schedule.
- According to the Investigator's opinion will benefit from continuing treatment with relacorilant
Exclusion Criteria:
Major Exclusion Criteria:
- Premature discontinuation from a relacorilant parent study.
- Has uncontrolled, clinically significant hypothyroidism or hyperthyroidism
- Has poorly controlled hypertension
- Has Stage ≥ 4 renal failure
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: relacorilant (CORT125134)
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CORT125134 is supplied as capsules for oral dosing.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Long-term safety of relacorilant
Time Frame: 36 months
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Number of participants with treatment-emergent adverse events (TEAEs)as assessed by CTCAE v4.0
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36 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Long-term benefit of relacorilant
Time Frame: 36 months
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Changes from Baseline as measured by glycated hemoglobin(HbA1c) and insulin resistance in patients with diabetes mellitus (DM) or glucose intolerance at Baseline in the parent study
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36 months
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Long-term benefit of relacorilant
Time Frame: 36 months
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Changes from Baseline as measured by systolic and diastolic blood pressure (BP) by ambulatory BP measurements (ABPM) in patients with uncontrolled hypertension (HTN) at Baseline in the parent study and in patients with controlled HTN taking at least one anti-HTN medication.
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36 months
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Long-term benefit of relacorilant
Time Frame: 36 months
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Changes from Baseline in weight as measured by Kg
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36 months
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Long-term benefit of relacorilant
Time Frame: 36 months
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Changes from Baseline in waist circumference measured in cm
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36 months
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Long-term benefit of relacorilant
Time Frame: 36 months
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Changes from Baselinein quality-of-life based on Cushing quality of life questionnaire 0 (worst) to 100 (best)
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36 months
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Long-term benefit of relacorilant
Time Frame: 36 months
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Changes from Baseline in hypthalamic-pituitary-adrenal (HPA) axis markers (Plasma ACTH and Fasting Cortisol) and Sex steroid hormone (testosterone and estradiol)
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36 months
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Andreas G Moraitis, MD, Corcept Therapeutics
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- Hypertension
- Type 2 Diabetes
- Cortisol
- Cushing Disease
- Adrenocortical Carcinoma
- Hypercortisolemia
- Cushingoid
- Impaired Glucose Intolerance
- Moon Facies
- Dorsocervical Fat Pad
- Adrenal Adenoma
- Adrenal Autonomy
- Cushing
- Cushing Syndrome
- Adrenal Corticotrophic Hormone (ACTH)
- Primary Pigmented Nodular Adrenal Disease (PPNAD)
- Adrenal Carcinoma
Additional Relevant MeSH Terms
Other Study ID Numbers
- CORT125134-452
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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