Efficacy and Safety of Topiramate in the Treatment of Sleep-Related Eating Disorder
Primary Purpose
Sleep-Related Eating Disorder
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Topiramate or Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Sleep-Related Eating Disorder focused on measuring Sleep-Related Eating Disorder, Topiramate, Parasomnia
Eligibility 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
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Topiramate
Placebo
Arm Description
Study medication arm, 25-300mg of Topiramate
Placebo arm of study, 25-300mg of sugar pill
Outcomes
Primary Outcome Measures
frequency and severity of sleep-related eating episodes
Secondary Outcome Measures
tolerability of topiramate
body weight
Full Information
NCT ID
NCT00606411
First Posted
January 22, 2008
Last Updated
August 12, 2019
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00606411
Brief Title
Efficacy and Safety of Topiramate in the Treatment of Sleep-Related Eating Disorder
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
January 2008 (Actual)
Primary Completion Date
November 29, 2018 (Actual)
Study Completion Date
November 29, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep-Related Eating Disorder
Keywords
Sleep-Related Eating Disorder, Topiramate, Parasomnia
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Topiramate
Arm Type
Active Comparator
Arm Description
Study medication arm, 25-300mg of Topiramate
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo arm of study, 25-300mg of sugar pill
Intervention Type
Drug
Intervention Name(s)
Topiramate or Placebo
Other Intervention Name(s)
Brand Name: Topamax
Intervention Description
25-300 mg tablets of topiramate and matching placebo, placed in blinded capsules
Primary Outcome Measure Information:
Title
frequency and severity of sleep-related eating episodes
Time Frame
every 2 weeks for 10 weeks
Secondary Outcome Measure Information:
Title
tolerability of topiramate
Time Frame
every other week for 10 weeks
Title
body weight
Time Frame
every other week for 10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John W Winkelman, MD, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
32227216
Citation
Winkelman JW, Wipper B, Purks J, Mei L, Schoerning L. Topiramate reduces nocturnal eating in sleep-related eating disorder. Sleep. 2020 Sep 14;43(9):zsaa060. doi: 10.1093/sleep/zsaa060.
Results Reference
derived
Learn more about this trial
Efficacy and Safety of Topiramate in the Treatment of Sleep-Related Eating Disorder
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