Efficacy and Safety of Topiramate in the Treatment of Sleep-Related Eating Disorder
April 18, 2024 updated by: John Winkelman, MD, PhD, Massachusetts General Hospital
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
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
34
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 61 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Topiramate
Study medication arm, 25-300mg of Topiramate
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25-300 mg tablets of topiramate and matching placebo, placed in blinded capsules
Other Names:
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Placebo Comparator: Placebo
Placebo arm of study, 25-300mg of sugar pill
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25-300 mg tablets of topiramate and matching placebo, placed in blinded capsules
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Frequency of Sleep-related Eating Episodes (Time Frame: Comparing Final Study Visit to Baseline)
Time Frame: every 2 weeks for 10 weeks
|
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.
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every 2 weeks for 10 weeks
|
|
The Clinician Global Impression (CGI) Scale
Time Frame: Day 1 (First Study Visit) to Day 63 (Final Study Visit) (assessed at last study visit)
|
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."
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Day 1 (First Study Visit) to Day 63 (Final Study Visit) (assessed at last study visit)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body Weight
Time Frame: every other week for 10 weeks
|
The change in body weight in the study participants was calculated comparing the participant's last study visit to their baseline weight.
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every other week for 10 weeks
|
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HbA1c (%)
Time Frame: Day 1 (First Study Visit) to Day 63 (Final Study Visit)
|
Change in HbA1c levels from randomization to the end of follow-up.
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Day 1 (First Study Visit) to Day 63 (Final Study Visit)
|
|
Average Total Sleep Time (Hours)
Time Frame: Day 1 (First Study Visit) to Day 63 (Final Study Visit)
|
Average sleep time over the course of the previous two weeks, comparing end results to baseline.
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Day 1 (First Study Visit) to Day 63 (Final Study Visit)
|
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Sleep Quality (Visual Analogue Scale or VAS)
Time Frame: Day 1 (First Study Visit) to Day 63 (Final Study Visit)
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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).
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Day 1 (First Study Visit) to Day 63 (Final Study Visit)
|
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The Patient Global Impression (PGI) Scale
Time Frame: Day 1 (First Study Visit) to Day 63 (Final Study Visit) (assessed at last study visit)
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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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: John W Winkelman, MD, PhD, Massachusetts General Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2008
Primary Completion (Actual)
November 29, 2018
Study Completion (Actual)
November 29, 2018
Study Registration Dates
First Submitted
January 22, 2008
First Submitted That Met QC Criteria
February 1, 2008
First Posted (Estimated)
February 4, 2008
Study Record Updates
Last Update Posted (Actual)
April 19, 2024
Last Update Submitted That Met QC Criteria
April 18, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MGH-2008P000662
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