NCT00220337

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 371 (actual)
• Sponsor: UCB Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Painful Diabetic Neuropathy

Interventions

Type	Name	Description
DRUG	Lacosamide	Lacosamide film-coated tablets; two times per day; up to 400 mg/day for 2.75 years

Timeline

• Start date: 2004-12-21
• Primary completion: 2007-10-31
• Completion: 2007-10-31
• First posted: 2005-09-22
• Last updated: 2023-07-24
• Results posted: 2023-07-24

Locations

1 site across 1 country: Germany