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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Sleep-Related Eating Disorder

Intervention / Treatment
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* Drug: Topiramate or Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Topiramate<br>Study medication arm, 25-300mg of Topiramate | Drug: Topiramate or Placebo<br>* 25-300 mg tablets of topiramate and matching placebo, placed in blinded capsules<br>* Other names: Brand Name: Topamax;|
| Placebo Comparator: Placebo<br>Placebo arm of study, 25-300mg of sugar pill | Drug: Topiramate or Placebo<br>* 25-300 mg tablets of topiramate and matching placebo, placed in blinded capsules<br>* Other names: Brand Name: Topamax;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| frequency and severity of sleep-related eating episodes |  | every 2 weeks for 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tolerability of topiramate |  | every other week for 10 weeks | 
| body weight |  | every other week for 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep-Related Eating Disorder, Topiramate, Parasomnia