Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00236886
Status:
COMPLETED
Last Update Posted:
2010-04-28
First Post:
2005-10-07
Brief Title:
Prospective Pilot Study on Metabolism and Weight Changes in Topiramate-Treated Epilepsy Patients
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
Prospective Pilot Study on Metabolism and Weight Changes in Subjects With Diagnosed Partial Onset Epilepsy With or Without Secondarily Generalized Seizures and Treated With Topiramate
Status:
COMPLETED
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess a possible predictor for weight loss seen in epilepsy patients treated with topiramate
Detailed Description:
Topiramate has been shown to be an effective anti-epileptic medication with a good safety profile In clinical trials some patients have experienced substantial weight loss This prospective single center open pilot study will investigate whether there is any metabolic predictor for the weight loss The patients will receive daily oral dose of topiramate in addition to anti-epileptic medications already prescribed by their physicians A battery of metabolic tests including Body Mass Index BMI lean body mass blood lipids and fasting glucose in tandem with other examinations will be taken before dispensing of topiramate after 3 months and at the final visit The study hypothesis is metabolic test results will provide a predictor of weight loss with topiramate Patients will receive between 25 to 400mg daily of topiramate by mouth in addition to current anti-epileptic medications for up to 1 year Dose will be adjusted up to 1000 mg daily by the investigators depending on the patients clinical response
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