This phase 3 trial is being conducted at approximately 80 sites in the United States (U.S.)
to investigate whether lacosamide (SPM 927) at different doses reduces pain in subjects with
diabetic neuropathy. Approximately 455 subjects will be randomized to placebo or to 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 greater than or equal to 4 on an 11-point Likert scale (0-10 scale) during
the 7 day period prior to the 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; and pain interference with
sleep (morning) and activity (evening). Use of rescue medication (acetaminophen) and
subjects' quality of life will be investigated. In addition, the safety and tolerability of
the different doses of lacosamide will be investigated.
- Diabetic neuropathy
- Subject has previously participated in this trial or subject has previously been
assigned to treatment in a trial of the drug under investigation in this trial.