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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 August 2014 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: August 12, 2014
Last verified: August 2014
  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 or Placebo
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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:


Further study details as provided by Massachusetts General 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 Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Topiramate
Study medication arm, 25-300mg of Topiramate
Drug: Topiramate or Placebo
25-300 mg tablets of topiramate and matching placebo, placed in blinded capsules
Other Name: Brand Name: Topamax
Placebo Comparator: Placebo
Placebo arm of study, 25-300mg of sugar pill
Drug: Topiramate or Placebo
25-300 mg tablets of topiramate and matching placebo, placed in blinded capsules
Other Name: Brand Name: Topamax

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
  • Previous history of Topiramate or Topamax use for any condition
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Laura Schoerning 617-643-6026 lschoerning@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: John W Winkelman, MD, PhD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: John Winkelman, MD, PhD, Associate Professor of Psychiatry, Harvard Medical School, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00606411     History of Changes
Other Study ID Numbers: BWH-HRC-2007-P-002187
Study First Received: January 22, 2008
Last Updated: August 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Sleep-Related Eating Disorder
Topiramate
Parasomnia

Additional relevant MeSH terms:
Eating Disorders
Disease
Mental Disorders
Pathologic Processes
Topiramate
Anti-Obesity Agents
Anticonvulsants
Central Nervous System Agents
Neuroprotective Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014