NCT00546351

Study Evaluating Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Distal Diabetic Neuropathy.

A Multi-center, Open-label, follow-on Trial to Assess the Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Distal Diabetic Neuropathy Including a Double-blind, Randomized Time Point Withdrawal Subtrial.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 621 (actual)
• Sponsor: UCB Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Painful Diabetic Neuropathy

Interventions

Type	Name	Description
DRUG	Lacosamide	50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years

Timeline

• Start date: 2004-05-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2007-10-18
• Last updated: 2023-09-21
• Results posted: 2012-04-19

Locations

101 sites across 15 countries: Austria, Belgium, Bulgaria, Czechia, Finland, France, Germany, Hungary, Italy, Poland, Romania, Russia, Serbia, Spain, United Kingdom