Conditions: Painful Diabetic Neuropathy
Keywords: Lacosamide
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 621
Healthy volunteers: no

Brief summary:
SP746 (NCT00546351) is a multi-center, open-label, follow-on trial. The purpose of this trial is to assess safety and tolerability of long-term exposure of lacosamide (previously referred to as SPM 927) in subjects with painful distal diabetic neuropathy.

Detailed description:

Arms:
arm 1: 50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.

Interventions: intervention 1: Lacosamide
Intervention descriptions: intervention 1: 50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years

Protocol document: