At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 426 enrolled
Drug / intervention
Lacosamide +1 moredrug
Likely dose
Lacosamide 50 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 Historical-controlled, Multicenter, Double-blind, Randomized Trial to Assess the Efficacy and Safety of Conversion to Lacosamide 400 mg/Day Monotherapy in Subjects With Partial-onset Seizures
In Brief
A Phase 3 clinical trial evaluating Lacosamide for Epilepsy. Completed, enrolled 426 participants across 158 sites in 13 countries.
Detailed Summary
The objective of this historical-controlled trial is to demonstrate the efficacy and safety of conversion to Lacosamide monotherapy in subjects with Partial-onset Seizures who are withdrawn from 1 to 2 marketed antiepileptic drugs.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy
CountriesAustralia, Austria, Canada, Denmark, France, Germany, Ireland, Italy, Poland, Puerto Rico, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2007
First PostedAug 2007
Primary CompletionDec 2012
TodayJul 2026
First PostedAug 27, 2007
Enrollment StartAug 1, 2007
Primary CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 18.8 years ago
Interventions
Lacosamidedrug
50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks.
Lacosamidedrug
50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks.