Study Evaluating Changes in Total Drug Load and Seizure Frequency Using Vimpat® (Lacosamide) in Combination Therapy (VICTOS)

UCB

Status: Completed

Conditions: Focal Epilepsy With and Without Secondary Generalization

Treatments: Drug: Lacosamide

Study type: Observational

Funder types: Industry

Identifiers

NCT01673282

SP1065

Details and patient eligibility

About

This observational study aims to investigate how VIMPAT® is used as adjunctive therapy in clinical practice and will also evaluate the subsequent change in the drug load of patients after addition of VIMPAT® to their treatment regimen.

Enrollment: 315 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• The patient has not received Vimpat® more than 7 days prior to start of Non-Interventional Study (NIS)
• The patient must have a diagnosis of epilepsy with partial-onset seizures with or without secondary generalization
• Based on the physician's clinical judgment, it is in the patient's best interest to be prescribed adjunctive Vimpat® (ie, the decision to prescribe Vimpat® is made by the physician)
• Patient must be at least 18 years of age
• The patient must have had at least one seizure within the last 3 months prior to enrolment

Trial design

315 participants in 2 patient groups

Vimpat + Na Channel Blocking AED

Description:

Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs) to include at least 1 sodium channel blocking AED.

Treatment:

Drug: Lacosamide

Vimpat + Non-Na Channel Blocking AED

Description:

Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs), none of which is a sodium channel blocking AED.

Treatment:

Drug: Lacosamide