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

Sleep-Related Eating Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00606411
• Other study ID #: MGH-2008P000662
• Status: Completed
• Phase: Early Phase 1
• Start date: January 2008
• Est. completion date: November 29, 2018

Study information

• Verified date: April 2024
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: November 29, 2018
• Est. primary completion date: November 29, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Feeding and Eating Disorders
• Sleep-Related Eating Disorder

Intervention

Drug:
• Topiramate or Placebo
25-300 mg tablets of topiramate and matching placebo, placed in blinded capsules

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Frequency of Sleep-related Eating Episodes (Time Frame: Comparing Final Study Visit to Baseline)	Frequency of sleep-related eating episodes was measured as the number of nights a participant had an episode within the previous two weeks. The change was measured by comparing the last study visit (by the participant) from to the baseline results.	every 2 weeks for 10 weeks
Primary	The Clinician Global Impression (CGI) Scale	The Clinician Global Impression (CGI) Scale is used by healthcare professionals to assess the overall severity of illness and change in a patient's condition over time. The scale ranges from 1 to 7, 1 being Very much improved and 7 being Very much worse. A participant with a score of 1 or 2 on the Clinician Global Impression scale was considered a "responder."	Day 1 (First Study Visit) to Day 63 (Final Study Visit) (assessed at last study visit)
Secondary	Body Weight	The change in body weight in the study participants was calculated comparing the participant's last study visit to their baseline weight.	every other week for 10 weeks
Secondary	HbA1c (%)	Change in HbA1c levels from randomization to the end of follow-up.	Day 1 (First Study Visit) to Day 63 (Final Study Visit)
Secondary	Average Total Sleep Time (Hours)	Average sleep time over the course of the previous two weeks, comparing end results to baseline.	Day 1 (First Study Visit) to Day 63 (Final Study Visit)
Secondary	Sleep Quality (Visual Analogue Scale or VAS)	Measured on visual analogue scale (VAS). VAS ranges were as follows: Sleep Quality; 0 = "Poorly" to 100 = "Great," Wakefulness; 0 = "Asleep/Not Awake" to 100 = "Fully Awake," Control; 0 = "No Control Over Eating" to 100 = "Full Control Over Eating," Memory; 0 = "No Memory of Eating" to 100 = "Fully Remember Eating". The change was calculated from baseline to the final study visit (day 63).	Day 1 (First Study Visit) to Day 63 (Final Study Visit)
Secondary	The Patient Global Impression (PGI) Scale	A participant with a score of 1 or 2 on the Patient Global Impression scale was considered a "responder."	Day 1 (First Study Visit) to Day 63 (Final Study Visit) (assessed at last study visit)