Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00231673
Status:
COMPLETED
Last Update Posted:
2011-06-08
First Post:
2005-09-30
Brief Title:
A Study To Evaluate The Effect Of Topiramate On Clinical And Electrophysiological Parameters In Subjects With Diabetic Peripheral Polyneuropathy
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
A Double-Blind Placebo-Controlled Parallel Group Study to Evaluate the Effect of Topiramate on Electrophysiological Parameters in Subjects With Diabetic Peripheral Polyneuropathy
Status:
COMPLETED
Status Verified Date:
2011-04
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 the study is to evaluate the effect of topiramate on clinical and electrophysiological parameters in patients with diabetic peripheral polyneuropathy The study will also evaluate the safety of topiramate in this patient population
Detailed Description:
This is a multicenter double-blind placebo-controlled study to evaluate the effect of topiramate on clinical and electrophysiological parameters in patients with diabetic peripheral polyneuropathy Patients will undergo the Baseline Phase when they are tapered off other pain medications have diabetes controlled and eligibility reassessed Patients will then be randomized to receive either topiramate or placebo and enter the Double-Blind Phase which consists of Titration Period topiramate dose will be titrated from 25mgday to 200mgday over 42 days and Maintenance Period study medication will be continued for 12 weeks After the Double-Blind Phase study medication will be tapered off during the Taper Phase whose duration will vary depending on each patient The evaluations include electrophysiological assessment quantitative sensory assessment and clinical assessment such as subjective pain scales Safety evaluations vital signs clinical laboratory evaluations physical and neurological examination and evaluations of adverse events will be conducted during the trial During the first 42 days doses of topiramate gradually increase to achieve the target dose 200mg daily by mouth and then the dose is maintained for 12 weeks after which the dose is slowly reduced and stopped over 12 weeks
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