Hypothalamic Obesity
Conditions
Keywords
Obesity
Brief summary
The extension protocol is designed to allow those patients randomized to placebo in the core portion of the protocol to receive a 6 month treatment of open label octreotide and allow those patients randomized to octreotide who appeared to benefit from treatment, to continue to receive octreotide.
Interventions
DRUGOctreotide
Sponsors
Novartis
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
\- Patient must provide written informed consent
Exclusion criteria
* Any patient that experienced unresolved safety complications at any time during the original protocol CSMS995B2403 * Patients with a history of gallstones or any patient developing gallstones during the course of the core protocol * Patients for whom there are safety or tolerability concerns for continuing Octreotide Depot * Any patient requiring additional treatment for their original cranial insult related to cranial trauma, or to tumor recurrence or its treatment Refer to the original protocol for details of inclusion &
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in BMI | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in weight, leptin, insulin AUC, C-peptide AUC, amylin AUC, glucose AUC, dietary intake, physical activity, waist-to-hip ratio, visceral and subcutaneous abdominal fat | — |
Outcome results
None listed