Status:
UNKNOWN
Canadian Continuation of Roll-over Study in Patients With Endogenous Cushing's Syndrome
Lead Sponsor:
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborating Sponsors:
RECORDATI GROUP
Conditions:
Endogenous Cushing Syndrome
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to continue the evaluation of long-term safety of osilodrostat in 7 Canadian patients who have already received osilodrostat treatment in a previous Global Recordati-spons...
Detailed Description
There will be no screening period for this study. Eligible subjects can start their treatment with osilodrostat as soon as they are enrolled in the study. The first study visit will be scheduled at th...
Eligibility Criteria
Inclusion
- Patient is currently participating in a Global Recordati-sponsored roll-over study receiving osilodrostat for any type of endogenous CS and has fulfilled all their requirements in the parent study.
- The patient is currently benefiting from treatment with osilodrostat, as determined by the Investigator.
- Patient has demonstrated compliance, as assessed by the Investigator, with the parent roll-over study protocol requirements.
- Willingness and ability to comply with scheduled visits and treatment plans.
- Written informed consent obtained prior to enrolling into the study
Exclusion
- Patient has been permanently discontinued from osilodrostat study treatment in the parent roll-over Recordati-sponsored study.
- New patients not previously enrolled in parent roll-over Recordatisponsored study.
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory evaluation.
Key Trial Info
Start Date :
October 24 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 24 2025
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT06131580
Start Date
October 24 2023
End Date
November 24 2025
Last Update
November 14 2023
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Alberta Hospital - Alberta Diabetes Institute
Edmonton, Alberta, Canada, T6G 2E1
2
Nova Scotia Health
Halifax, Nova Scotia, Canada, B3H 1V7
3
CHUS Sherbrooke
Sherbrooke, Quebec, Canada, J1H 5N4