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

UCB Pharma GmbH315 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

315

Conditions

Focal Epilepsy With and Without Secondary Generalization

Interventions

LacosamideDRUG

Route of Administration: oral/subcutaneous Form and Dosage: Tablet (50 mg/100 mg/150 mg, 200 mg); Syrup (10 mg/ml); Solution for infusion (10 mg/ml).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (42)

Innsbruck, Austria

Outcomes

Primary Outcomes

The Percent Change in Ratio of Dose and Defined Daily Dose (DDD) for the Drug Load of Concomitant Anti-Epileptic Drugs (AEDs) From Baseline to the End of Observation Period (Day 0 to 6 Months)

Drug load is defined as the sum of the ratios of the actual doses divided by the defined daily dose for all concomitant AEDs.

Time frame: From Baseline (Day 0) to 6 months

Data from ClinicalTrials.gov

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