At a glance
ClinicalIndex Comparison RecordN/ACompleted· 1,005 enrolled
Drug / intervention
Lacosamidedrug
Likely dose
Not stated in 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.
Post-Authorization Safety Study to Evaluate the Long-Term Safety and Tolerability of Vimpat® (Lacosamide) as Add-On Therapy in Epilepsy Patients With Partial-Onset Seizures Who Are Uncontrolled on Current Therapy
In Brief
An observational study evaluating Lacosamide for Epilepsies, Partial. Completed, enrolled 1,005 participants across 62 sites in 5 countries.
Detailed Summary
SP942 is a non-interventional post-authorization safety study (PASS) to evaluate the long-term safety and tolerability of Vimpat® (Lacosamide, LCM) as add-on treatment in patients with Epilepsy 16 years and older with partial-onset seizures who are uncontrolled on current therapy. Using reported adverse events, the incidence of certain cardiovascular and psychiatric events will be evaluated.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsies, Partial
CountriesFrance, Germany, Netherlands, Spain, United Kingdom
Collaborators--
Timeline
N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartOct 2008
First PostedOct 2008
Primary CompletionMar 2012
TodayJul 2026
First PostedOct 15, 2008
Enrollment StartOct 1, 2008
Primary CompletionMar 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 17.7 years ago
Interventions
Lacosamidedrug
Vimpat was used as per site routine practices, and in-line with the marketing authorization.