Focal Epilepsy With and Without Secondary Generalization Clinical Trial
— VICTOSOfficial 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
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.
| Status | Completed |
| Enrollment | 315 |
| Est. completion date | July 2015 |
| Est. primary completion date | July 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Austria | 60 | Innsbruck | |
| Austria | 61 | Mauer bei Amstetten | |
| Austria | 63 | Ried | |
| Germany | 18 | Berlin | |
| Germany | 34 | Berlin | |
| Germany | 43 | Berlin | |
| Germany | 66 | Berlin | |
| Germany | 23 | Bonn | |
| Germany | 25 | Dortmund | |
| Germany | 35 | Duesseldorf | |
| Germany | 48 | Erbach | |
| Germany | 59 | Erlangen | |
| Germany | 30 | Essen | |
| Germany | 47 | Giessen | |
| Germany | 29 | Goettingen | |
| Germany | 37 | Goettingen | |
| Germany | 05 | Haag | |
| Germany | 12 | Halle | |
| Germany | 19 | Halle | |
| Germany | 39 | Heidenheim | |
| Germany | 54 | Ibbenbueren | |
| Germany | 27 | Jena | |
| Germany | 04 | Jülich | |
| Germany | 13 | Kehl-Kork | |
| Germany | 36 | Kiel | |
| Germany | 28 | Koeln | |
| Germany | 40 | Koeln | |
| Germany | 38 | Leipzig | |
| Germany | 52 | Magdeburg | |
| Germany | 67 | Mainz | |
| Germany | 49 | Mittweida | |
| Germany | 01 | München | |
| Germany | 08 | Oranienburg | |
| Germany | 17 | Osnabrück | |
| Germany | 14 | Radeberg | |
| Germany | 15 | Rüsselsheim | |
| Germany | 16 | Senftenberg | |
| Germany | 41 | Stuttgart | |
| Germany | 09 | Troisdorf | |
| Germany | 22 | Tübingen | |
| Germany | 20 | Ulm | |
| Germany | 07 | Westerstede |
| Lead Sponsor | Collaborator |
|---|---|
| UCB Pharma GmbH |
Austria, Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | From Baseline (Day 0) to 6 months | No |