Clinical Trial: A Trial to Assess the Efficacy and Safety of SPM 927 in Subjects With Painful Distal Diabetic Neuropathy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial to Assess the Efficacy and Safety OF 200, 400, AND 600 mg/Day SPM 927 in Subjects With Painful Distal This phase 2b trial is being conducted at approximately 60 sites in the US to investigate whether lacosamide (SPM 927) at different doses reduces pain in subjects with diabetic neuropathy. Approximately 360 subjects will be randomized to placebo or one of three doses of lacosamide. To qualify for this trial, subjects with symptoms of painful distal diabetic neuropathy ranging in duration from 6 months to 5 years must have an average pain intensity of ≥4 on an 11-point Likert scale (0-10 scale) during the 7 day period prior to start of treatment.

To determine what effect lacosamide has on diabetic neuropathic pain, subjects will use a diary to record their daily pain intensity (morning and evening), pain interference with sleep (morning) and activity (evening). Use of rescue medication (acetaminophen) and subjects' quality of life will be investigated. In addition, safety and tolerability of the different doses of lacosamide will be investigated.

Detailed Summary:
Sponsor: UCB Pharma

Current Primary Outcome: To investigate the efficacy of 200, 400, and 600 mg/day of lacosamide compared with placebo in reducing pain in subjects with painful distal diabetic neuropathy.

Original Primary Outcome:

Current Secondary Outcome: To investigate the effect of lacosamide on subjects' perception of pain, sleep, activity, quality of life, as well as to investigate the pharmacokinetics and safety of lacosamide.

Original Secondary Outcome:

Information By: UCB Pharma

Dates:
Date Received: October 6, 2005
Date Started: April 2004
Date Completion:
Last Updated: September 19, 2014
Last Verified: February 2010