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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02659475
Study type	Interventional
Source	Lindner Center of HOPE
Contact
Status	Completed
Phase	Phase 2
Start date	September 2015
Completion date	September 2016

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See also
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