Long-Term Safety Study for Cushing's Syndrome

(ISS-CA-2023 Trial)

Recruiting at 2 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

André Lacroix, MD

Principal Investigator

Centre hospitalier de l'Université de Montréal (CHUM)

Eligibility Criteria

This trial is for Canadian patients with Cushing's Syndrome who have shown good adherence to a previous osilodrostat treatment study, are willing to follow the new study plan, and continue to benefit from osilodrostat as judged by their doctor. It excludes new patients, those discontinued from prior osilodrostat studies, or women who are pregnant or nursing.

Inclusion Criteria

You are already taking osilodrostat as part of another study sponsored by Global Recordati for a condition called endogenous CS and have completed all the requirements for that study.

I am willing and able to follow the study's schedule and treatment plan.

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

Exclusion Criteria

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

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

Treatment Details

Interventions

• Osilodrostat (Corticosteroid)

Trial Overview The trial aims to assess the long-term safety of continued use of osilodrostat in seven Canadian patients with endogenous Cushing's Syndrome. These individuals have previously participated in another related study and will keep receiving this medication under investigator supervision.

Participant Groups

Group I: Participant Group/Arm Experimental Treatment 1 Intervention

Other: osilodrostat open label, with patients receiving same dose as provided in the parent study

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials

389

Recruited

143,000+

Recordati Rare Diseases

Industry Sponsor

Trials

14

Recruited

540+