Efficacy and Safety of Topiramate in the Treatment of Sleep-Related Eating Disorder
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ClinicalTrials.gov Identifier: NCT00606411 |
Recruitment Status :
Completed
First Posted : February 4, 2008
Last Update Posted : August 14, 2019
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Sponsor:
Massachusetts General Hospital
Information provided by (Responsible Party):
John Winkelman, MD, PhD, Massachusetts General Hospital
Tracking Information | ||||
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First Submitted Date ICMJE | January 22, 2008 | |||
First Posted Date ICMJE | February 4, 2008 | |||
Last Update Posted Date | August 14, 2019 | |||
Actual Study Start Date ICMJE | January 2008 | |||
Actual Primary Completion Date | November 29, 2018 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
frequency and severity of sleep-related eating episodes [ Time Frame: every 2 weeks for 10 weeks ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Efficacy and Safety of Topiramate in the Treatment of Sleep-Related Eating Disorder | |||
Official Title ICMJE | 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 | |||
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. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Early Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Sleep-Related Eating Disorder | |||
Intervention ICMJE | Drug: Topiramate or Placebo
25-300 mg tablets of topiramate and matching placebo, placed in blinded capsules
Other Name: Brand Name: Topamax
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Study Arms ICMJE |
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Publications * | 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. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
29 | |||
Original Estimated Enrollment ICMJE |
40 | |||
Actual Study Completion Date ICMJE | November 29, 2018 | |||
Actual Primary Completion Date | November 29, 2018 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00606411 | |||
Other Study ID Numbers ICMJE | MGH-2008P000662 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | John Winkelman, MD, PhD, Massachusetts General Hospital | |||
Original Responsible Party | John W. Winkelman, M.D., Ph.D., Brigham and Women's Hospital | |||
Current Study Sponsor ICMJE | Massachusetts General Hospital | |||
Original Study Sponsor ICMJE | Brigham and Women's Hospital | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Massachusetts General Hospital | |||
Verification Date | August 2019 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |