Pediatric Hypothalamic Obesity

Novartis

Status and phase

Completed

Phase 4

Conditions

Obesity

Treatments

Drug: Sandostatin LAR

Study type

Interventional

Funder types

Industry

Identifiers

NCT00076362

CSMS995B2403

Details and patient eligibility

About

This trial is being conducted in pediatric patients with Hypothalamic Obesity. This generally occurs in people who have had an injury to or tumor in their hypothalamus (gland or organ that secretes hormones). The purpose of this trial is to see how an investigational treatment controls the hormone insulin by lowering the level of insulin in the body resulting in a weight loss in children who are at least 6 years of age but less than 18 years of age. Some children in this trial will receive placebo.

To qualify for this study, you and your child's doctor must feel that your child's weight is inadequately controlled within a year from the time of injury to the hypothalamus or tumor of the hypothalamus. This study will help to determine if an investigational treatment is of benefit in controlling a child's weight.

Enrollment

60 patients

Sex

All

Ages

6 to 18 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Male and female patients ages 6 to less than 18
Patients who have experienced any form of cranial insult related to cranial trauma, or to a tumor or it's treatment (i.e. surgery, radiation, and/or chemotherapy)
Patients who are at least one year out following therapy for their tumor
Patients who have severe cardiovascular dysfunction (for example cardiomyopathy, congestive heart failure (NYHA Class III or IV), unstable angina, sustained ventricular tachycardia, ventricular fibrillation) will be excluded
Patients with severe neurologic handicaps which preclude normal physical activity will be excluded.
Patients confined to bed and those patients who are wheelchair bound which prevents them from activities of daily living or normal physical activity, i.e. walking, will be excluded from the trial
Your child must be greater than 120% of their ideal body weight for their height or have a body mass index that is greater than or equal to 27.