Official Title: “A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Determine the Efficacy and Safety of Topiramate in the Treatment of Sleep-Related Eating Disorder”

The purpose of the study is to learn about the safety and effectiveness of oral (taken by mouth) topiramate in treating Sleep-Related Eating Disorder (SRED).

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: April 2009

This is a single center, 13-week, outpatient, randomized, double-blind, placebo-controlled, parallel group, pilot study of topiramate in subjects with Sleep-Related Eating Disorder (SRED). The primary objective of this study is to investigate the efficacy and safety of topiramate compared to placebo in the treatment of Sleep-Related Eating Disorder. SRED is a disorder that consists of out of control eating during the night with little or no awareness of the events. In this study we are comparing topiramate to placebo. A placebo is a pill that looks exactly like the study drug, but it does not have any active drug in it. Topamax (topiramate) is approved by the U.S. Food and Drug Administration (FDA) as a therapy for epilepsy, but topiramate has not been approved by the FDA for SRED.

Intervention(s) in this Clinical Trial

• Drug: Topiramate
  • 25-300 mg tablets of topiramate and matching placebo, placed in blinded capsules

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: 2
  • Placebo controlled arm, double-blind treatment with placebo, 25-300mg
• Experimental: 1
  • Flexible dose treatment with topiramate, 25-300mg

Primary Measures

• frequency and severity of sleep-related eating episodes
  • Time Frame: every 2 weeks for 10 weeks
    Safety Issue?: No

Secondary Measures

• tolerability of topiramate
  • Time Frame: every other week for 10 weeks
    Safety Issue?: Yes
• body weight
  • Time Frame: every other week for 10 weeks
    Safety Issue?: No

Inclusion Criteria:

• Adults 18-65
• Diagnosis of SRED
• Must be able to swallow capsules and follow instructions

Exclusion Criteria:

• Women who are pregnant or lactating
• Other sleep disorders
• Kidney or Liver disease
• Night shift workers
• History of non-response or adverse reactions to topiramate

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Brigham and Women's Hospital

Overall Clinical Trial Officials and Contacts

John W Winkelman, MD, PhD Principal Investigator Brigham and Women's Hospital  

Overall Contact: Jessica F Saunders 617-783-1496 SleepResearch@sleephealth.com

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00606411

Study ID Number: BWH-HRC-2007-P-002187

ClinicalTrials.gov Identifier: NCT00606411

Health Authority: United States: Institutional Review Board