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

Information source: Massachusetts General Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Sleep-Related Eating Disorder

Intervention: Topiramate or Placebo (Drug)

Phase: Phase 0

Status: Recruiting

Sponsored by: Massachusetts General Hospital

Official(s) and/or principal investigator(s):
John W Winkelman, MD, PhD, Principal Investigator, Affiliation: Massachusetts General Hospital

Overall contact:
Laura Schoerning, Phone: 617-643-6026, Email: lschoerning1@partners.org

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).

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: frequency and severity of sleep-related eating episodes

Secondary outcome:

tolerability of topiramate

body weight

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

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

Laura Schoerning, Phone: 617-643-6026, Email: lschoerning1@partners.org

Massachusetts General Hospital, Boston, Massachusetts 02114, United States; Recruiting
Additional Information

Starting date: January 2008
Last updated: April 15, 2015

Page last updated: August 23, 2015

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