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

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.

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Key information

Conditions

Focal Epilepsy With and Without Secondary Generalization Brain Diseases Central Nervous System Diseases Epilepsies, Partial Epilepsy Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

60, Innsbruck, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lacosamide

Drug

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).

Other names: Vimpat, LCM

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)

Time frame: From Baseline (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.

Sponsors and collaborators

Lead sponsor

UCB Pharma GmbH

Industry

Registry information

Official study title

A Non-interventional, Observational Study Evaluating Changes in Drug Load and Seizure Frequency Using Vimpat (Lacosamide) in Daily Clinical Practice in Combination Therapy With Sodium Channel Blocking Anti-epileptic Drugs (AEDs) or Non Sodium Channel Blocking AEDs

Acronym: VICTOS

Important dates

Study start: 2012
Primary completion: 2015
Study completion: 2015
First posted: Aug 27, 2012
Registry last updated: Nov 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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