Cushing Syndrome
Conditions
Keywords
Cushing Syndrome, Cushing Disease, Cushing, Hypercortisolemia, Cushingoid, Type 2 Diabetes, Impaired Glucose Intolerance, Hypertension, Adrenal Corticotrophic Hormone (ACTH), Adrenocortical Carcinoma, Primary Pigmented Nodular Adrenal Disease (PPNAD), Moon Facies, Dorsocervical Fat Pad, Adrenal Adenoma, Adrenal Carcinoma, Adrenal Autonomy, Cortisol
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.
Interventions
CORT125134 is supplied as capsules for oral dosing.
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Long-term safety of relacorilant | 36 months | Number of participants with treatment-emergent adverse events (TEAEs)as assessed by CTCAE v4.0 |
Countries
Austria, Canada, Germany, Israel, Italy, Netherlands, Poland, Romania, Spain, United States
Contacts
Corcept Therapeutics