A Follow-On Trial to Assess the Long Term Safety and Efficacy of SPM 927 in Painful Distal Diabetic Neuropathy

This phase 2/3 open-label trial is being conducted at approximately 100 sites in the US to
assess the safety and tolerability of long-term treatment with lacosamide (SPM 927) in
subjects with painful diabetic neuropathy. Approximately 525 subjects will be enrolled. To
qualify for this trial, subjects with symptoms of painful distal diabetic neuropathy ranging
in duration from 6 months to 5 years must have completed trials SP665, SP742, or SP768 and,
in the investigator's opinion, may benefit from long-term administration of lacosamide.
Subjects will be titrated to their optimal dose of lacosamide (up to 600mg/day). The safety
and tolerability of the different doses of lacosamide will be investigated throughout the
trial. In addition, to determine what effect lacosamide has on diabetic neuropathic pain,
subjects will use a diary to record their daily pain intensity and pain interference with
sleep and activity. Subjects' quality of life will also be investigated.

Inclusion Criteria:

- Subjects who completed Study SP665, SP742, or SP768 and, in the investigators opinion,
might benefit from long-term administration of SPM 927. Exception: subjects who
prematurely discontinued Study SP742 or SP768 due to lack of efficacy or due to
intolerability to trial medication may be eligible to participate in Study SP745,
after consultation with the medical monitor.

Exclusion Criteria:

- Subject has clinically relevant electrocardiogram (ECG) abnormalities, or QT-corrected
(QTc) interval >=500 milliseconds (ms), and/or a QTc interval increase of >=60ms from
the mean pre-dose QTc value at Visit 2 of Studies SP665, SP742 or SP768.

- Subject has aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >=3
times the upper limit of the normal range (ULN) with total bilirubin >=2 times ULN or
transaminases (AST and/or ALT) >=5 times ULN.

- Subject has a clinically relevant medical condition that, in the opinion of the
investigator, jeopardizes or compromises the subject's ability to participate in this
trial.