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Efficacy and Safety of Topiramate in the Treatment of Sleep-Related Eating Disorder
This study is currently recruiting participants.
Study NCT00606411   Information provided by Brigham and Women's Hospital
First Received: January 22, 2008   Last Updated: September 15, 2009   History of Changes

January 22, 2008
September 15, 2009
January 2008
April 2010   (final data collection date for primary outcome measure)
frequency and severity of sleep-related eating episodes [ Time Frame: every 2 weeks for 10 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00606411 on ClinicalTrials.gov Archive Site
  • tolerability of topiramate [ Time Frame: every other week for 10 weeks ] [ Designated as safety issue: Yes ]
  • body weight [ Time Frame: every other week for 10 weeks ] [ Designated as safety issue: No ]
Same as current
 
Efficacy and Safety of Topiramate in the Treatment of Sleep-Related Eating Disorder
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).

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.

Phase 0
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Sleep-Related Eating Disorder
Drug: Topiramate
  • Placebo Comparator: Placebo controlled arm, double-blind treatment with placebo, 25-300mg
  • Experimental: Flexible dose treatment with topiramate, 25-300mg
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
40
August 2010
April 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact: Kate Miley 617-783-1496 ext 115 jwwinkelman@partners.org
United States
 
NCT00606411
John W. Winkelman, M.D., Ph.D., Brigham and Women's Hospital
BWH-HRC-2007-P-002187
Brigham and Women's Hospital
 
Principal Investigator: John W Winkelman, MD, PhD Brigham and Women's Hospital
Brigham and Women's Hospital
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP