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

• ClinicalTrials.gov Identifier: NCT00606411
• Recruitment Status: Completed
• First Posted: February 4, 2008
• Last Update Posted: August 14, 2019
• Sponsor: Massachusetts General Hospital
• Information provided by (Responsible Party): John Winkelman, MD, PhD, Massachusetts General Hospital

Tracking Information

• First Submitted Date: January 22, 2008
• First Posted Date: February 4, 2008
• Last Update Posted Date: August 14, 2019
• Actual Study Start Date: January 2008
• Actual Primary Completion Date: November 29, 2018 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: February 1, 2008): frequency and severity of sleep-related eating episodes [ Time Frame: every 2 weeks for 10 weeks ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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: Interventional
• Study Phase: Early Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
• Condition: Sleep-Related Eating Disorder

Intervention

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 *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 12, 2019): 29
• Original Estimated Enrollment (submitted: February 1, 2008): 40
• Actual Study Completion Date: November 29, 2018
• Actual Primary Completion Date: November 29, 2018 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00606411
• Other Study ID Numbers: MGH-2008P000662
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: 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: Massachusetts General Hospital
• Original Study Sponsor: Brigham and Women's Hospital
• Collaborators: Not Provided

Investigators

• Principal Investigator: John W Winkelman, MD, PhD; Massachusetts General Hospital

• PRS Account: Massachusetts General Hospital
• Verification Date: August 2019