A Trial to Assess the Efficacy and Safety of 400mg/Day Lacosamide in Subjects With Painful Diabetic Neuropathy
The purpose of this trial is to assess whether 400mg/day of lacosamide is effective in reducing pain caused by distal diabetic neuropathy. Two dose-escalation schemes for lacosamide will be used to further determine the efficacy of the "standard" scheme and to evaluate the efficacy and safety of a more rapid titration scheme. Subjects will be randomly assigned to one of three treatment groups. Subjects in two of the groups will receive lacosamide at a dose of 400mg/day, but different dose-escalation schemes will be used to reach this final dose. The third group of subjects will receive a placebo. Subjects will have a 2 in 3 (66 %) chance of getting lacosamide.
The maximum lacosamide dose in this trial will be 400mg/day. The maximum treatment duration will be 18 weeks, including a two-week Pre-Treatment Phase and a 12 weeks period on a stable dose of lacosamide or placebo.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Multicenter, Randomized, Double-blind, Placebo Controlled Trial to Assess the Efficacy and Safety of 400mg/Day Lacosamide in Subjects With Painful Diabetic Neuropathy Using Two Different Titration Schemes|
- To investigate the efficacy of LCM compared with placebo in reducing pain in subjects with painful distal diabetic neuropathy. Two titration schemes will be used; the first is a standard titration scheme such that the target dose of 400mg/day [ Time Frame: 8 days and 22 days ]
- To investigate the onset of action under treatment of LCM, the effect of LCM on subjects' perception of pain, sleep, activity, and quality of life, and to further investigate the safety of LCM
|Study Start Date:||June 2006|
|Study Completion Date:||June 2007|
|Primary Completion Date:||June 2007 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00350103
|SCHWARZ BIOSCIENCES GmbH|
|Study Director:||UCB Clinical Trial Call Center||UCB Pharma|