Roll-over study to assess long-term safety in patients with endogenous Cushing’s syndrome who have completed a prior Novartis-sponsored osilodrostat study

Phase 1

• Conditions: Cushing's syndrome; MedDRA version: 20.0Level: PTClassification code 10011652Term: Cushing's syndromeSystem Organ Class: 10014698 - Endocrine disorders; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2017-002840-34-NL
• Lead Sponsor: Recordati AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-31
• Last Update Posted: 22 March 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Currently participating in a Global Novartis-sponsored osilodrostat study
2. Currently benefiting from treatment with osilodrostat, as determined by the Investigator
3. Demonstrated compliance, as assessed by the Investigator, with the parent 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 roll-over study
Are the trial subjects under 18? yes
Number of subjects for this age range: 5
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 170
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

1. Permanently discontinued from osilodrostat study treatment in a parent Novartis-sponsor study
2. Receiving osilodrostat in combination with unapproved or experimental treatments for any type of endogenous CS
3. Pregnant or nursing women
4. Women of child-bearing potential, unless they are using highly effective methods of contraception during dosing and for 1 week after stopping medication

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified