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

UCB

Status: Completed

Conditions: Epilepsies, Partial

Treatments: Drug: Lacosamide

Study type: Observational

Funder types: Industry

Identifiers

NCT00771927

SP0942

Details and patient eligibility

About

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.

Enrollment: 1,005 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,005 participants in 2 patient groups

Lacosamide

Description:

Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with add-on Vimpat

Treatment:

Drug: Lacosamide

Other AED

Description:

Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with other approved AED as add-on therapy