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

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Mass General Brigham

Status and phase

Completed
Early Phase 1

Conditions

Sleep-Related Eating Disorder

Treatments

Drug: Topiramate or Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT00606411
MGH-2008P000662

Details and patient eligibility

About

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).

Full 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.

Enrollment

34 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

34 participants in 2 patient groups, including a placebo group

Topiramate
Active Comparator group
Description:
Study medication arm, 25-300mg of Topiramate
Treatment:
Drug: Topiramate or Placebo
Placebo
Placebo Comparator group
Description:
Placebo arm of study, 25-300mg of sugar pill
Treatment:
Drug: Topiramate or Placebo

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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