To evaluatie the long term safety of treatment with osilodrostat for patients with Cushing Syndrome. In addition to evaluating the proportion of patients with clinical benefit (as assessed by the investigator) and determening frequency, severity and…
ID
Source
Brief title
Condition
- Hypothalamus and pituitary gland disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To evaluate long term safety data through frequency and severity of AE/SAE
Secondary outcome
To evaluate clinical benefit as assessed by the investigator. As well as
frequency, severity and summary of relevant safety assessments sucha s
laboratorium evaluation, vital signs, ECG and MRI.
Background summary
Osilodrostat is also known under the codename LCI699. Osilodrostat is not yet
registered for use by the Dutch health authority. Physicians can not yet use
this drug to treat patients with Cushing syndrome. Research is needed to obtain
information on the safety and effectiveness of the use of osilodrostat in the
treatment of patients with Cushing syndrome.
Study objective
To evaluatie the long term safety of treatment with osilodrostat for patients
with Cushing Syndrome. In addition to evaluating the proportion of patients
with clinical benefit (as assessed by the investigator) and determening
frequency, severity and summary of relevant safety assessments.
Study design
This is a multi-center, open label phase IIb study to evaluate the long-term
safety of osilodrostat in subjects receiving osilodrostat in a Global
Novartis-sponsored study which has fulfilled its requirements for the primary
objective, and who are judged by their parent study Investigator
as benefiting from continued treatment with osilodrostat..There will be no
screening period for this study. Eligible subjects can start their treatment
with osilodrostat as soon as they are enrolled in the study. The first study
visit will be scheduled at the time of the last study visit for the parent
study.
Intervention
Use of osilodrostat, and clinic visits and study assessments associated with
that.
Study burden and risks
The risks are those associated with the use of osilodrostat, the possible
side-effects or adverse events of the drug. The burden consist of the quarterly
visits of the patient to the clinic to assess side-effects and continued
clinical benefit as well as the study assessments conducted during these
visits.
Lindenstrasse 8
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Lindenstrasse 8
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Listed location countries
Age
Inclusion criteria
1. Patient is currently participating in a Global Recordati-sponsored study
receiving
osilodrostat for any type of endogenous CS and has fulfilled all the
requirements in the parent study.
2. 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 study protocol requirements.
4. Patient is willing and able to comply with scheduled visits and treatment
plans.
5. Written informed consent/adolescent assent obtained prior to enrolling into
the
roll-over study.
Exclusion criteria
1. Patient has been permanently discontinued from osilodrostat study treatment
in a parent Novartis-sponsor study.
2. Patients who are receiving osilodrostat in combination with unapproved or
experimental treatments for any type of endogenous CS.
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR201700284034-NL |
| ClinicalTrials.gov | NCT03606408 |
| CCMO | NL69125.078.19 |