A Phase 2/3 interventional study of topiramate in Obesity and Binge-Eating Disorder, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.. Completed. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2011-06-10.
Sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · Phase 2/3, Interventional, and Treatment
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.
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.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's enrollment of 407 is above the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →Johnson & Johnson Pharmaceutical Research & Development, L.L.C. is the lead sponsor of 458 studies on the registry; none are open to participants now.
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Exclusion Criteria:
The rate of change in the number of binge days per week from baseline at 16 weeks or final visit.
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This study is completed, as verified in Apr 2010. You cannot join it, but the record below documents what was studied.
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Johnson & Johnson Pharmaceutical Research & Development, L.L.C.