Roll-over study to assess long-term safety in patients with endogenous Cushing’s syndrome who have completed a prior Novartis-sponsored osilodrostat study
- Conditions
- Cushing's syndromeMedDRA version: 20.0Level: PTClassification code 10011652Term: Cushing's syndromeSystem Organ Class: 10014698 - Endocrine disordersTherapeutic area: Diseases [C] - Hormonal diseases [C19]
- Registration Number
- EUCTR2017-002840-34-BG
- Lead Sponsor
- Recordati AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 200
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
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<br>Frequency, severity and summaries of relevant safety assessments,<br>including : laboratory evaluations, vital signs (blood pressure and body<br>weight), ECG and pituitary MRI.;Timepoint(s) of evaluation of this end point: At each scheduled visit