A Study of Octreotide Depot vs Saline Control in Pediatric Hypothalamic Obesity Patients

A Study of Octreotide Depot vs Saline Control in Pediatric Hypothalamic Obesity Patients

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.

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 & 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.