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Efficacy and Safety of Topiramate in the Treatment of Sleep-Related Eating Disorder

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2016 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
John Winkelman, MD, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00606411
First received: January 22, 2008
Last updated: March 22, 2016
Last verified: March 2016
History of Changes

January 22, 2008
March 22, 2016
January 2008
December 2017   (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
Not Provided
Not Provided
 
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.
Interventional
Phase 0
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Sleep-Related Eating Disorder
Drug: Topiramate or Placebo
25-300 mg tablets of topiramate and matching placebo, placed in blinded capsules
Other Name: Brand Name: Topamax
  • Active Comparator: Topiramate
    Study medication arm, 25-300mg of Topiramate
    Intervention: Drug: Topiramate or Placebo
  • Placebo Comparator: Placebo
    Placebo arm of study, 25-300mg of sugar pill
    Intervention: Drug: Topiramate or Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
Not Provided
December 2017   (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
  • Previous history of Topiramate or Topamax use for any condition
Both
18 Years to 65 Years   (Adult)
No
Contact: Leslie Mei 617-643-6026 lamei@partners.org
United States
 
NCT00606411
MGH-2008P000662
No
Not Provided
Not Provided
John Winkelman, MD, PhD, Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Principal Investigator: John W Winkelman, MD, PhD Massachusetts General Hospital
Massachusetts General Hospital
March 2016

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