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

Sponsor:	Brigham and Women's Hospital
Information provided by:	Brigham and Women's Hospital
ClinicalTrials.gov Identifier:	NCT00606411

Purpose

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).

Condition	Intervention	Phase
Sleep-Related Eating Disorder	Drug: Topiramate	Phase 0

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

Resource links provided by NLM:

MedlinePlus related topics: Eating Disorders

Drug Information available for: Topiramate

U.S. FDA Resources

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:

frequency and severity of sleep-related eating episodes [ Time Frame: every 2 weeks for 10 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	40
Study Start Date:	January 2008
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
2: Placebo Comparator Placebo controlled arm, double-blind treatment with placebo, 25-300mg	Drug: Topiramate 25-300 mg tablets of topiramate and matching placebo, placed in blinded capsules
1: Experimental Flexible dose treatment with topiramate, 25-300mg	Drug: Topiramate 25-300 mg tablets of topiramate and matching placebo, placed in blinded capsules

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00606411

Contacts

Contact: Kate Miley

617-783-1496 ext 115

jwwinkelman@partners.org

Locations

United States, Massachusetts
Sleep Health Centers	Recruiting
Brighton, Massachusetts, United States, 02135

Sponsors and Collaborators

Brigham and Women's Hospital

Investigators

Principal Investigator:

John W Winkelman, MD, PhD

Brigham and Women's Hospital

More Information

No publications provided

Responsible Party:	Brigham and Women's Hospital ( John W. Winkelman, M.D., Ph.D. )
Study ID Numbers:	BWH-HRC-2007-P-002187
Study First Received:	January 22, 2008
Last Updated:	September 15, 2009
ClinicalTrials.gov Identifier:	NCT00606411 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:

Sleep-Related Eating Disorder
Topiramate
Parasomnia

Additional relevant MeSH terms:

Disease
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents
Pharmacologic Actions
Anti-Obesity Agents
Pathologic Processes

Mental Disorders
Therapeutic Uses
Topiramate
Central Nervous System Agents
Eating Disorders
Anticonvulsants

ClinicalTrials.gov processed this record on November 27, 2009