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Efficacy and Safety of Topiramate in the Treatment of Sleep-Related Eating Disorder
This study is currently recruiting participants.
Verified March 2016 by John Winkelman, MD, PhD, Massachusetts General Hospital
Sponsor:
Massachusetts General Hospital
Information provided by (Responsible Party):
John Winkelman, MD, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00606411
First received: January 22, 2008
Last updated: March 22, 2016
Last verified: March 2016
| Tracking Information | |||||
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| First Received Date ICMJE | January 22, 2008 | ||||
| Last Updated Date | March 22, 2016 | ||||
| Start Date ICMJE | January 2008 | ||||
| Estimated Primary Completion Date | December 2017 (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 | Complete list of historical versions of study NCT00606411 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | 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 | Early Phase 1 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (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 |
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| Publications * | Not Provided | ||||
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* 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 | Recruiting | ||||
| Estimated Enrollment ICMJE | 40 | ||||
| Completion Date | Not Provided | ||||
| Estimated Primary Completion Date | December 2017 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years to 65 Years (Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| 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 | Not Provided | ||||
| Responsible Party | John Winkelman, MD, PhD, Massachusetts General Hospital | ||||
| Study Sponsor ICMJE | Massachusetts General Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | Massachusetts General Hospital | ||||
| Verification Date | March 2016 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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