Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00210808
Status:
COMPLETED
Last Update Posted:
2011-06-10
First Post:
2005-09-13
Brief Title:
A Study of the Effectiveness and Safety of Topiramate in the Treatment of Moderate to Severe Binge-eating Disorder Associated With Obesity
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
Binge-Eating Disorder BED is characterized by recurrent binge eating without extreme behaviors to lose weight eg 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 subjects 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 andor 100 mg or placebo in increasing doses starting at 25 mgday 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 400mgday or MTD for addn 12 wks
Topiramate tablets 25 andor 100 mg or placebo in increasing doses starting at 25 mgday 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 400mgday or MTD for addn 12 wks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None