Study Evaluating Changes in Total Drug Load and Seizure Frequency Using Vimpat® (Lacosamide) in Combination Therapy (VICTOS)
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.
Focal Epilepsy With and Without Secondary Generalization
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official 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|
- 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 ] [ Designated as safety issue: No ]Drug load is defined as the sum of the ratios of the actual doses divided by the defined daily dose for all concomitant AEDs.
|Study Start Date:||July 2012|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
LCM and concomitant sodium channel blocking AEDs
Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs) to include at least 1 sodium channel blocking AED.
LCM and concomitant non sodium channel blocking AEDs
Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs), none of which is a sodium channel blocking AED.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01673282
|Contact: UCB Clinical Trial Call Center||+ 1 887 822 ext 9493|
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|Study Director:||UCB Clinical Trial Call Center||UCB Pharma|