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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2018-11-29

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).

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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.

Conditions

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Sleep-Related Eating Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Topiramate

Study medication arm, 25-300mg of Topiramate

Group Type ACTIVE_COMPARATOR

Topiramate or Placebo

Intervention Type DRUG

25-300 mg tablets of topiramate and matching placebo, placed in blinded capsules

Placebo

Placebo arm of study, 25-300mg of sugar pill

Group Type PLACEBO_COMPARATOR

Topiramate or Placebo

Intervention Type DRUG

25-300 mg tablets of topiramate and matching placebo, placed in blinded capsules

Interventions

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Topiramate or Placebo

25-300 mg tablets of topiramate and matching placebo, placed in blinded capsules

Intervention Type DRUG

Other Intervention Names

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Brand Name: Topamax

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No