Efficacy and Safety of Phentermine/Topiramate in Youth With Hypothalamic Obesity

Hypothalamic obesity (HO) refers to the substantial weight gain that often complicates hypothalamic brain tumors. Children with this treatment-recalcitrant form of obesity have excess rates of metabolic sequelae compared to otherwise healthy children with similar obesity, and later experience excess mortality related to cardiometabolic disease. In this pilot trial, our objective is to gather key preliminary data about phentermine/topiramate (Ph/T) that is FDA-approved for "common" obesity but has never been tested in HO. The subset of individuals with HO who experience hyperphagia or excess da

Trial Details

NCT ID
NCT06299891
Phase
PHASE2
Sponsor
Seattle Children's Hospital
Status
RECRUITING
Cancer Type
Brain Cancer
Interventions
  • Phentermine / Topiramate Extended Release Oral Capsule [Qsymia]
  • Placebo
Locations (sample)
  • Philadelphia, Pennsylvania, United States|39.95238,-75.16362
  • Seattle, Washington, United States|47.60621,-122.33207

Key Eligibility Criteria

  • Males and Females; Ages 6-28 years (inclusive)
  • History of rapid weight gain related to tumor onset or treatment, as assessed by an experienced endocrinologist (for example, change in BMI z-score…
  • Obesity (BMI \> 95th%ile for age/sex using CDC 2000 reference for under 18; BMI \> 30 kg/m2 for 18+ years)
  • Recent evidence of hypothalamic injury by brain MRI with central review; \>6 months status-post definitive therapy (surgery, chemotherapy, or radia…

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Brain Cancer Trials on Trialify →