A Study of Octreotide Depot vs Saline Control in Pediatric Hypothalamic Obesity Patients
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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.
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Ages Eligible for Study:
6 Years to 17 Years (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
- Patient must provide written informed consent
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 & exclusion criteria. Any patient granted a waiver to participate in the core protocol will be allowed to continue to participate in the extension protocol.
Other protocol-defined inclusion / exclusion criteria may apply.