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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00606411
Recruitment Status : Completed
First Posted : February 4, 2008
Last Update Posted : August 14, 2019
Sponsor:
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 August 14, 2019
Actual Study Start Date  ICMJE January 2008
Actual Primary Completion Date November 29, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 1, 2008)
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
Current Secondary Outcome Measures  ICMJE
 (submitted: February 1, 2008)
  • 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 Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE 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  ICMJE
  • 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 * 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.

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: August 12, 2019)
29
Original Estimated Enrollment  ICMJE
 (submitted: February 1, 2008)
40
Actual Study Completion Date  ICMJE November 29, 2018
Actual Primary Completion Date November 29, 2018   (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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
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 No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party John Winkelman, MD, PhD, Massachusetts General Hospital
Original Responsible Party John W. Winkelman, M.D., Ph.D., Brigham and Women's Hospital
Current Study Sponsor  ICMJE Massachusetts General Hospital
Original Study Sponsor  ICMJE Brigham and Women's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: John W Winkelman, MD, PhD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date August 2019

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