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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 John Winkelman, MD, PhD, Massachusetts General Hospital

Sponsor:

ClinicalTrials.gov Identifier:

NCT00606411

First Posted: February 4, 2008

Last Update Posted: March 23, 2016

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

Information provided by (Responsible Party):

John Winkelman, MD, PhD, Massachusetts General Hospital

Tracking Information

First Submitted Date ^ICMJE

January 22, 2008

First Posted Date ^ICMJE

February 4, 2008

Last Update Posted Date

March 23, 2016

Start Date ^ICMJE

January 2008

Estimated Primary Completion Date

December 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

frequency and severity of sleep-related eating episodes [ Time Frame: every 2 weeks for 10 weeks ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00606411 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

tolerability of topiramate [ Time Frame: every other week for 10 weeks ]
body weight [ Time Frame: every other week for 10 weeks ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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).

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.

Study Type ^ICMJE

Interventional

Study Phase

Early Phase 1

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Sleep-Related Eating Disorder

Intervention ^ICMJE

Drug: Topiramate or Placebo

25-300 mg tablets of topiramate and matching placebo, placed in blinded capsules

Other Name: Brand Name: Topamax

Study Arms

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Estimated Primary Completion Date

December 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years to 65 Years (Adult)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Leslie Mei

617-643-6026

lamei@partners.org

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00606411

Other Study ID Numbers ^ICMJE

MGH-2008P000662

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

John Winkelman, MD, PhD, Massachusetts General Hospital

Study Sponsor ^ICMJE

Massachusetts General Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

John W Winkelman, MD, PhD

Massachusetts General Hospital

PRS Account

Massachusetts General Hospital

Verification Date

March 2016

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

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