Canadian Continuation of Roll-over Study in Patients With Endogenous Cushing's Syndrome

• Status: Active, not recruiting
• Trial end date: 2025-11-24
• Target enrollment: 0
• Participant gender: All

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-sponsored roll-over study and who, based on investigators' judgement, will continue benefiting with its administration.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
• Collaborator: Recordati Rare Diseases

Criteria

Inclusion Criteria:

1. 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.

2. The patient is currently benefiting from treatment with osilodrostat, as determined by the Investigator.

3. Patient has demonstrated compliance, as assessed by the Investigator, with the parent roll-over study protocol requirements.

4. Willingness and ability to comply with scheduled visits and treatment plans.

5. Written informed consent obtained prior to enrolling into the study

Exclusion Criteria:

1. Patient has been permanently discontinued from osilodrostat study treatment in the parent roll-over Recordati-sponsored study.

2. New patients not previously enrolled in parent roll-over Recordatisponsored study.

3. 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.