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

Novartis32 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hypothalamic Obesity

Interventions

OctreotideDRUG

Eligibility

Sex: ALLMin age: 6 YearsMax age: 17 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Change from baseline in BMI

Secondary Outcomes

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

Data from ClinicalTrials.gov

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