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-ES
• Lead Sponsor: ovartis Farmacéutica, S.A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-11
• Last Update Posted: 7 January 2019

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? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 190
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate long-term safety data;Secondary Objective: To evaluate clinical benefit as assessed by the Investigator;Primary end point(s): Frequency and severity of AEs/SAEs;Timepoint(s) of evaluation of this end point: Throughout the trial

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Proportion of patients with clinical benefit as assessed by the Investigator at scheduled visits;Timepoint(s) of evaluation of this end point: At each scheduled visit