A Trial to Assess the Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Diabetic Neuropathy
Status:
Completed
Trial end date:
2007-10-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to determine if lacosamide (SPM 927) is safe if taken for a
longer period of time and whether it continues to work well to treat pain.
Subjects will receive lacosamide at a dose that will be individually determined to be the one
that provides most pain relief with the least side effects. The maximum dose will be
600mg/day. Subjects may participate in this trial until October 2007. This time may be
extended to allow them to participate until lacosamide is commercially available.
If a subject meet the requirements for the study at Visit 1 and after a two weeks phase
without trial medication, s/he enters a Titration Phase to determine the personal optimal
dose of lacosamide. When this dose is reached s/he will enter the Maintenance Phase and will
be asked to return for visits every 4 weeks for the first 24 weeks and every 12 weeks
thereafter.