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Purpose

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).

Condition

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Early Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Topiramate 		Study medication arm, 25-300mg of Topiramate
  • Drug: Topiramate or Placebo
    25-300 mg tablets of topiramate and matching placebo, placed in blinded capsules
    Other names:
    • Brand Name: Topamax
Placebo Comparator
Placebo 		Placebo arm of study, 25-300mg of sugar pill
  • Drug: Topiramate or Placebo
    25-300 mg tablets of topiramate and matching placebo, placed in blinded capsules
    Other names:
    • Brand Name: Topamax

More Details

Status
Completed
Sponsor
Massachusetts General Hospital

Study Contact

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.