NCT02659475

Phentermine/Topiramate Extended Release in Binge Eating Disorder (BED)

Open-label Phentermine/Topiramate Extended Release (PHEN/TPM ER; Qsymia®) in Ten Subjects With Overweight or Obesity and DSM-V Binge Eating Disorder (BED)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Lindner Center of HOPE · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The goal of this project is to evaluate the effectiveness and tolerability of the novel weight management medication PHEN/TPM ER (Qsymia®)along with nutritional and lifestyle modification counseling in the treatment of binge eating disorder (BED) in overweight or obese individuals.

Detailed description

This is an exploratory open-label trial of PHEN/TPM ER (Qsymia®) in BED. It is hypothesized that PHEN/TPM ER (Qsymia®) will be an effective, safe, and well tolerated treatment for BED and propose to conduct a 1-site, 12-week, open-label, flexible dose study of PHEN/TPM ER (Qsymia®) in 10 outpatients, ages 18 through 65 years, with BED. It is also hypothesized that PHEN/TPM ER (Qsymia®) will reduce weight and binge eating behavior, and will be well tolerated. The primary objective is to show that PHEN/TPM ER (Qsymia®) along with nutritional and lifestyle modification counseling is effective in reducing weight in overweight or obese patients with BED. Secondary objectives are to show that PHEN/TPM ER (Qsymia®) is effective in reducing frequency of binge eating episodes and associated eating psychopathology and is safe and well tolerated in patients with BED.

Conditions

• Binge Eating Disorder

Interventions

Type	Name	Description
DRUG	PHEN/TPM ER (Qsymia®)	PHEN/TPM ER (Qsymia®)

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-07-01
• Completion: 2016-09-01
• First posted: 2016-01-20
• Last updated: 2016-09-20

Locations

1 site across 1 country: United States