At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 621 enrolled
Drug / intervention
Lacosamidedrug
Likely dose
Lacosamide 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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.
In Brief
A Phase 3 clinical trial evaluating Lacosamide for Painful Diabetic Neuropathy. Completed, enrolled 621 participants across 101 sites in 15 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPainful Diabetic Neuropathy
CountriesAustria, Belgium, Bulgaria, Czechia, Finland, France, Germany, Hungary, Italy, Poland, Romania, Russia, Serbia, Spain, United Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2004
First PostedOct 2007
Primary CompletionJan 2011
TodayJul 2026
First PostedOct 18, 2007
Enrollment StartMay 1, 2004
Primary CompletionJan 1, 2011
TodayJul 2, 2026
Enrollment to primary: 6.7 yearsPosted 18.7 years ago
Interventions
Lacosamidedrug
50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years