N/A
Completed N=1,004
Post-Authorization Safety Study to Assess the Safety of Vimpat as add-on Therapy in Patients With Partial-onset Seizures
Epilepsies, Partial
Source: ClinicalTrials.gov NCT00771927 ↗
Enrolled (actual)
1,004
Serious AEs
14.1%
Results posted
Apr 2013
Primary outcomePrimary: 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 — 4; 3 Treatment-Emergent Adverse Events
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
4; 3 | — |
| SECONDARY The Incidence of Predefined Psychiatric 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 |
22; 31 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00771927). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.