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

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

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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