CompletedNot Applicable

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

France1,005 participantsStarted 2008-10

Plain-language 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.

Who can participate

Age range16 Years

SexALL

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Inclusion Criteria: * This study includes any subject 16 years or older who has an Epilepsy diagnosis with Partial-Onset Seizures; and whose Seizure activity is uncontrolled on current therapy * Patients who are prescribed Vimpat or any other add-on Antiepileptic Drug (AED) may be included in the study * The initiation of an add-on AED therapy can not be more than 2 days before the patient's start of the study Exclusion Criteria: * N/A

What they're measuring

The Incidence of Predefined Cardiovascular Treatment-Emergent Adverse Events (TEAEs) in Epilepsy Patients With Partial-onset Seizures While on Vimpat or Any Other add-on Antiepileptic Drug (AED) Treatment During the Study

Timeframe: From Baseline up to 12 months

Trial details

NCT IDNCT00771927

SponsorUCB Pharma

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2012-03

Results submitted2013-03-08

View on ClinicalTrials.gov More Epilepsies, Partial trials