NCT02040311

Topiramate: Long-Term Maintenance of Weight Loss Induced by Low-Calorie Diet in Obese Subjects

A Multicenter Randomized, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy and Safety of Topiramate in Weight Loss Maintenance in Obese Subjects Following Participation in an Intensive, Non-pharmacologic Weight Loss Program

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 701 (actual)
• Sponsor: University of Copenhagen · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine the efficacy and safety of topiramate (96 mg or 192 mg daily) as compared to placebo in maintaining weight loss in obese subjects who participated in an eight week intensive non-pharmacologic weight loss program. The primary efficacy endpoint will be the percent change in body weight from enrollment visit to week 60.

Detailed description

The study was a randomized, double-blind, placebo-controlled, parallel-group, multicenter trial. It was originally designed to last a total of 74 weeks: an 8 week non.pharmacologic low-calorie (800 to 1000 kcl/d) weight loss run-in phase, an 8 week titration phase, 52 week maintenance phase, and 6 week drug taper and follow up phase.

Conditions

• Obesity

Interventions

Type	Name	Description
DRUG	Topiramate 96 mg daily
DRUG	Topiramate 192 mg daily
DRUG	Placebo

Timeline

• Start date: 2000-08-01
• Primary completion: 2002-06-01
• Completion: 2002-06-01
• First posted: 2014-01-20
• Last updated: 2014-01-20

Locations

1 site across 1 country: Denmark