Extension Study to Evaluate the Safety of Long-Term Use of Relacorilant in Patients With Cushing Syndrome
- Registration Number
- NCT03604198
- Lead Sponsor
- Corcept Therapeutics
- Brief Summary
This is an open-label extension study to evaluate the long-term safety of relacorilant in patients with endogenous Cushing syndrome who successfully completed participation in a Corcept-sponsored study of relacorilant and may benefit from continuing 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 125
-
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
-
Major Exclusion Criteria:
- Premature discontinuation from a relacorilant parent study.
- Has uncontrolled, clinically significant hypothyroidism or hyperthyroidism
- Has poorly controlled hypertension
- Has Stage โฅ 4 renal failure
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description relacorilant (CORT125134) relacorilant -
- Primary Outcome Measures
Name Time Method Long-term safety of relacorilant 36 months Number of participants with treatment-emergent adverse events (TEAEs)as assessed by CTCAE v4.0
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (49)
Site 7
๐บ๐ธEl Paso, Texas, United States
Site 38
๐ช๐ธMรกlaga, Spain
Site 19
๐ช๐ธSevilla, Spain
Site 18
๐ช๐ธGirona, Spain
Site 17
๐ช๐ธMadrid, Spain
Site 43
๐บ๐ธCleveland, Ohio, United States
Site 11
๐บ๐ธDallas, Texas, United States
Site 50
๐บ๐ธMiami, Florida, United States
Site 10
๐บ๐ธAtlanta, Georgia, United States
Site 49
๐บ๐ธPhoenix, Arizona, United States
Site 35
๐บ๐ธStanford, California, United States
Site 39
๐บ๐ธTorrance, California, United States
Site 9
๐บ๐ธChicago, Illinois, United States
Site 1
๐บ๐ธIndianapolis, Indiana, United States
Site 5
๐บ๐ธMetairie, Louisiana, United States
Site 27
๐บ๐ธBaltimore, Maryland, United States
Site 13
๐บ๐ธFall River, Massachusetts, United States
Site 8
๐บ๐ธAnn Arbor, Michigan, United States
Site 36
๐บ๐ธRochester, Minnesota, United States
Site 34
๐บ๐ธJackson, Mississippi, United States
Site 3
๐บ๐ธSaint Louis, Missouri, United States
Site 55
๐บ๐ธReno, Nevada, United States
Site 6
๐บ๐ธAlbany, New York, United States
Site 24
๐บ๐ธNew York, New York, United States
Site 4
๐บ๐ธWilmington, North Carolina, United States
Site 41
๐บ๐ธOklahoma City, Oklahoma, United States
Site 2
๐บ๐ธPittsburgh, Pennsylvania, United States
Site 46
๐บ๐ธPittsburgh, Pennsylvania, United States
Site 32
๐บ๐ธFort Worth, Texas, United States
Site 12
๐บ๐ธHouston, Texas, United States
Site 14
๐ฆ๐นWien, Austria
Site 51
๐จ๐ฆNova Scotia, Canada
Site 16
๐ฉ๐ชMunich, Germany
Site 42
๐ฉ๐ชWuerzburg, Germany
Site 20
๐ฎ๐ฑRamat Gan, Israel
Site 29
๐ฎ๐ฑTel Aviv, Israel
Site 40
๐ฎ๐นAncona, Italy
Site 44
๐ฎ๐นMessina, Italy
Site 25
๐ฎ๐นMilano, Italy
Site 21
๐ฎ๐นNapoli, Italy
Site 48
๐ฎ๐นPadova, Italy
Site 52
๐ฎ๐นTorino, Italy
Site 33
๐ณ๐ฑRotterdam, Netherlands
Site 47
๐ต๐ฑKrakรณw, Poland
Site 45
๐ต๐ฑLublin, Poland
Site 28
๐ท๐ดBucharest, Romania
Site 37
๐ท๐ดBucuresti, Romania
Site 31
๐ท๐ดBucuresti, Romania
Site 53
๐ช๐ธAlicante, Spain