Diabetic Neuropathy Clinical Trial
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 Diabetic Neuropathy
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.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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