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A Study of the Effectiveness and Safety of Topiramate in the Treatment of Moderate to Severe Binge-eating Disorder Associated With Obesity

This study has been completed.
Sponsor:
Collaborator:
Ortho-McNeil Neurologics, Inc.
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00210808
First received: September 13, 2005
Last updated: June 8, 2011
Last verified: April 2010
  Purpose

The purpose of this study is to evaluate the safety and effectiveness of topiramate compared to placebo in reducing the number of binge days in patients with moderate to severe binge-eating disorder associated with obesity.


Condition Intervention Phase
Obesity
Binge-Eating Disorder
Drug: topiramate
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Flexible-dose Study to Assess the Safety and Efficacy of Topiramate in the Treatment of Moderate to Severe Binge-eating Disorder Associated With Obesity

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • The rate of change in the number of binge days per week from baseline at 16 weeks or final visit.

Enrollment: 407
Study Start Date: September 2003
Study Completion Date: March 2005
Detailed Description:

Binge-Eating Disorder (BED) is characterized by recurrent binge eating without extreme behaviors to lose weight (e.g., self-induced vomiting, misuse of laxatives) resulting in marked distress, feelings of loss of control, and association with overweight or obesity. Treatment goals for binge-eating therapies include reducing the urge to binge, weight loss, and management of co-existing medical and psychological conditions. Currently, there are no approved medication treatments available for BED, however, studies have shown that treatment for BED (psychotherapy or the use of medications) may be effective at reducing the number of binges, while effects on weight have been variable. Topiramate has been approved for epilepsy in adults and children aged 2 years and above, and for the prevention of migraine in adults. This is a randomized, double-blind, flexible dose, parallel group study to determine if topiramate, a prescription medication approved by the Food & Drug Administration for the treatment of epilepsy and the prevention of migraine, administered at a dose of 400 mg per day or the subject's maximum tolerated dose, is safe and effective compared with placebo in patients with moderate to severe binge-eating disorder associated with obesity. Subjects will have an equal chance of receiving topiramate or placebo. The study hypothesis is that topiramate will be more effective than placebo in reducing the number of binge days per week in patients with moderate to severe binge-eating disorder associated with obesity and is generally well tolerated. Patients completing the 16-week double-blind phase of the trial are eligible to participate in the 12-week open-label phase of the study.

Topiramate tablets (25 and/or 100 mg) or placebo in increasing doses starting at 25 mg/day up to 400 mg/ day (or MTD) during first 8 wks, achieved dose maintained for additional 8 wks. If entering OL reduce DB medication while increasing dose of active topiramate to 400mg/day or MTD for addn 12 wks.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of binge-eating disorder
  • 3 or more binge days per week in the 2 weeks prior to baseline
  • Obese (body mass index >=30 and <=50 kilograms per square meter)
  • Uncomplicated/controlled Type II diabetes or hypertension are acceptable
  • In generally good health
  • If female capable of having children, using acceptable method of birth control

Exclusion Criteria:

  • No current or past history of schizophrenia, other psychotic disorder, or bipolar disorder
  • Significant depression that requires treatment with medication or therapy
  • At risk to self or others
  • No current or recent (within 3 months) diagnosis of abusing drugs or alcohol
  • Initiation of formal psychiatric therapy in past 6 months for binge-eating disorder or any other psychiatric disorder
  • Pregnant or breast-feeding
  • No clinically significant medical condition
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00210808

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Ortho-McNeil Neurologics, Inc.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00210808     History of Changes
Other Study ID Numbers: CR004657
Study First Received: September 13, 2005
Last Updated: June 8, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Binge-Eating Disorder
medication treatment
obesity
bingeing

Additional relevant MeSH terms:
Binge-Eating Disorder
Bulimia
Disease
Eating Disorders
Obesity
Body Weight
Hyperphagia
Mental Disorders
Nutrition Disorders
Overnutrition
Overweight
Pathologic Processes
Signs and Symptoms
Signs and Symptoms, Digestive
Topiramate
Anti-Obesity Agents
Anticonvulsants
Central Nervous System Agents
Neuroprotective Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014