At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 51 enrolled
Drug / intervention
Levoketoconazoledrug
Likely dose
Levoketoconazole 1200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-label Extension Study of Levoketoconazole (2S,4R-ketoconazole) in the Treatment of Endogenous Cushing's Syndrome
In Brief
A Phase 3 clinical trial evaluating Levoketoconazole for Cushing Syndrome and Cushing Disease. Completed, enrolled 51 participants across 30 sites in 11 countries.
Detailed Summary
This is a long-term, open-label extension study of levoketoconazole in participants with endogenous Cushing's Syndrome.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCushing Syndrome, Cushing Disease
CountriesBulgaria, France, Greece, Hungary, Israel, Italy, Netherlands, Poland, Romania, Spain, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedAug 2018
Enrollment StartJan 2019
Primary CompletionDec 2022
TodayJul 2026
First PostedAug 8, 2018
Enrollment StartJan 7, 2019
Primary CompletionDec 31, 2022
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 7.9 years ago
Interventions
Levoketoconazoledrug
Levoketoconazole up to 1200 mg daily