NCT00771927

Post-Authorization Safety Study to Assess the Safety of Vimpat as add-on Therapy in Patients With Partial-onset Seizures

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,005 (actual)
• Sponsor: UCB Pharma · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Epilepsies, Partial

Interventions

Type	Name	Description
DRUG	Lacosamide	Vimpat was used as per site routine practices, and in-line with the marketing authorization.

Timeline

• Start date: 2008-10-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2008-10-15
• Last updated: 2014-10-27
• Results posted: 2013-04-22

Locations

62 sites across 5 countries: France, Germany, Netherlands, Spain, United Kingdom