At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 370 enrolled
Drug / intervention
lacosamidedrug
Likely dose
lacosamide 50mgfrom 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.
An Open-label Extension Trial to Determine Tolerability and Efficacy of Long-term Oral SPM 927 as Adjunctive Therapy in Patients With Partial Seizures
In Brief
A Phase 2 clinical trial evaluating lacosamide for Partial Epilepsies. Completed, enrolled 370 participants across 59 sites in 8 countries.
Detailed Summary
The purpose of this trial is to determine whether lacosamide is safe and effective for long-term use in patients with partial-seizures from epilepsy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPartial Epilepsies
CountriesGermany, Hungary, Lithuania, Poland, Sweden, Switzerland, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2001
First PostedNov 2007
Primary CompletionFeb 2010
TodayJul 2026
First PostedNov 1, 2007
Enrollment StartAug 1, 2001
Primary CompletionFeb 1, 2010
TodayJul 2, 2026
Enrollment to primary: 8.5 yearsPosted 18.7 years ago
Interventions
lacosamidedrug
50mg and 100mg tablets up to 800 mg/day as twice a day (BID) dosing throughout the trial