Clinical trial NCT00606411: Efficacy and Safety of Topiramate in the Treatment of Sleep-Related Eating Disorder
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Sleep-Related Eating Disorder
Keywords: Sleep-Related Eating Disorder
Topiramate
Parasomnia
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2008-02-04
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Frequency of Sleep-related Eating Episodes (Time Frame: Comparing Final Study Visit to Baseline)
timeFrame: every 2 weeks for 10 weeks
measure: The Clinician Global Impression (CGI) Scale
timeFrame: Day 1 (First Study Visit) to Day 63 (Final Study Visit) (assessed at last study visit)
Secondary outcomes:
measure: Body Weight
timeFrame: every other week for 10 weeks
measure: HbA1c (%)
timeFrame: Day 1 (First Study Visit) to Day 63 (Final Study Visit)
measure: Average Total Sleep Time (Hours)
timeFrame: Day 1 (First Study Visit) to Day 63 (Final Study Visit)
measure: Sleep Quality (Visual Analogue Scale or VAS)
timeFrame: Day 1 (First Study Visit) to Day 63 (Final Study Visit)
measure: The Patient Global Impression (PGI) Scale
timeFrame: Day 1 (First Study Visit) to Day 63 (Final Study Visit) (assessed at last study visit)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: John W Winkelman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Winkelman JW, Wipper B, Purks J, Mei L, Schoerning L. Topiramate reduces nocturnal eating in sleep-related eating disorder. Sleep. 2020 Sep 14;43(9):zsaa060. doi: 10.1093/sleep/zsaa060.