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Clinical trial

Open-label Treatment in Cushing's Syndrome (OPTICS)

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Last updated:7th Jan 2019
Identifier: NCT03621280

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

Detailed Description:
This is a long-term, OLE study of levoketoconazole in subjects with endogenous CS who have completed one or both parent studies or otherwise potentially qualify for this study, as defined in the eligibility criteria.


Study Type: Interventional  (Clinical Trial)
Estimated Enrollment: 60 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Open-Label Extension Study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Extension Study of Levoketoconazole (2S,4R-ketoconazole) in the Treatment of Endogenous Cushing's Syndrome
Actual Study Start Date: January 7, 2019
Estimated Primary Completion Date: April 2021
Estimated Study Completion Date: June 2021

Arm:
- Experimental:
Levoketoconazole

Category Value
Date last updated at source 2019-03-19
Study type(s) Interventional
Expected enrolment 60
Study start date 2019-01-07
Estimated primary completion date 2021-04-01

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