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

Tracking Information
First Submitted Date ICMJE	January 22, 2008
First Posted Date ICMJE	February 4, 2008
Last Update Posted Date	March 21, 2018
Study Start Date ICMJE	January 2008
Estimated Primary Completion Date	June 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	Complete list of historical versions of study NCT00606411 on ClinicalTrials.gov Archive Site
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 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; (submitted: February 1, 2008)	40
Original Estimated Enrollment ICMJE	Same as current
Study Completion Date	Not Provided
Estimated Primary Completion Date	June 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	Sexes Eligible for Study: All
Ages	18 Years to 65 Years (Adult)
Accepts Healthy Volunteers	No
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	No
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 2018
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP