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A Trial to Assess the Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Diabetic Neuropathy

Painful Diabetic Neuropathy Clinical Trial

Official title:
A Multicenter, Open-label Trial to Assess the Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Diabetic Neuropathy

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00220337
Study type Interventional
Source UCB Pharma
Contact
Status Completed
Phase Phase 3
Start date December 21, 2004
Completion date October 31, 2007
View Details
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