Phentermine/Topiramate for Hypothalamic Obesity in Youth
This study is investigating Phentermine/Topiramate Extended Release Oral Capsule (Qsymia) for young people aged 6 to 28 with hypothalamic obesity (HO). HO is significant weight gain often seen after hypothalamic brain tumors, which can lead to serious health problems. Qsymia is approved for 'common' obesity, but hasn't been tested for HO. Researchers want to see if Qsymia is safe and effective for weight loss in this group, especially for those who experience extreme hunger (hyperphagia) or excessive daytime sleepiness. The study will compare Qsymia to a placebo (an inactive substance) to understand its effects.
- Study design
- This is a 28-week, double-blind, randomized, parallel-arm Phase 2 pilot trial. It plans to enroll 24 participants, who will be randomly assigned to receive either Qsymia or a placebo.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be monitored for treatment-emergent adverse events from the start of the study until the completion of week 28.
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Efficacy and Safety of Phentermine/Topiramate in Youth With Hypothalamic Obesity
At a glance
Conditions
Where it's being run
2 sites across 2 statesStudy leadership
- Christian L Roth, MD · PRINCIPAL_INVESTIGATOR · University of Washington, Dept. of Pediatrics
- Shana E McCormack, MD · PRINCIPAL_INVESTIGATOR · Children's Hospital of Philadelphia
Who to contact
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What this trial measures
- Treatment-emergent adverse eventsFrom baseline to completion of week 28
Incidence of treatment-emergent adverse events including any during withdrawal in study drug vs. placebo.