A Trial to Assess the Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Diabetic Neuropathy
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.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Multicenter, Open-label Trial to Assess the Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Diabetic Neuropathy|
- To assess the tolerability and safety of long-term lacosamide administration in subjects with painful diabetic neuropathy. Assessment of adverse events, changes in laboratory parameters, ECGs, and physical examinations.
- To evaluate the efficacy of long-term use of lacosamide in this indication. Efficacy will be determined by pain score ratings assessed in a patient's diary and with ratings at the clinic visits.
|Study Start Date:||December 2004|
|Study Completion Date:||October 2007|
|Primary Completion Date:||October 2007 (Final data collection date for primary outcome measure)|
Open label active treatment
Lacosamide film-coated tablets; two times per day; up to 400 mg/day for 2.75 years
Other Name: SPM 927