NCT03621280

Open-label Treatment in Cushing's Syndrome

An Open-label Extension Study of Levoketoconazole (2S,4R-ketoconazole) in the Treatment of Endogenous Cushing's Syndrome

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Cortendo AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a long-term, open-label extension study of levoketoconazole in participants with endogenous Cushing's Syndrome.

Detailed description

This is a long-term, open-label extension (OLE) study of levoketoconazole in participants with endogenous Cushing's Syndrome (CS) who have completed one or both parent studies or otherwise potentially qualify for this study, as defined in the eligibility criteria.

Conditions

• Cushing Syndrome
• Cushing Disease

Interventions

Type	Name	Description
DRUG	Levoketoconazole	Levoketoconazole up to 1200 mg daily

Timeline

• Start date: 2019-01-07
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2018-08-08
• Last updated: 2025-06-19
• Results posted: 2025-06-19

Locations

30 sites across 11 countries: United States, Bulgaria, France, Greece, Hungary, Israel, Italy, Netherlands, Poland, Romania, Spain

Regulatory

• FDA-regulated drug study