Clinical trial NCT01673282: Study Evaluating Changes in Total Drug Load and Seizure Frequency Using Vimpat® (Lacosamide) in Combination Therapy
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Focal Epilepsy With and Without Secondary Generalization
Keywords: Lacosamide
Vimpat
Focal Epilepsy
Drug Load
AED
SP1065
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2012-08-27
Enrollment: 315
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with focal epilepsy with or without secondary generalization.

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: 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)
timeFrame: From Baseline (Day 0) to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: 60
city: Mauer bei Amstetten
country: Austria
facility: 61
city: Ried
country: Austria
facility: 63
city: Berlin
country: Germany
facility: 18
city: Berlin
country: Germany
facility: 34
city: Berlin
country: Germany
facility: 43
city: Berlin
country: Germany
facility: 66
city: Bonn
country: Germany
facility: 23
city: Dortmund
country: Germany
facility: 25
city: Duesseldorf
country: Germany
facility: 35
city: Erbach
country: Germany
facility: 48
city: Erlangen
country: Germany
facility: 59
city: Essen
country: Germany
facility: 30
city: Giessen
country: Germany
facility: 47
city: Goettingen
country: Germany
facility: 29
city: Goettingen
country: Germany
facility: 37
city: Haag
country: Germany
facility: 05
city: Halle
country: Germany
facility: 12
city: Halle
country: Germany
facility: 19
city: Heidenheim
country: Germany
facility: 39
city: Ibbenbueren
country: Germany
facility: 54
city: Jena
country: Germany
facility: 27
city: Jülich
country: Germany
facility: 04
city: Kehl-Kork
country: Germany
facility: 13
city: Kiel
country: Germany
facility: 36
city: Koeln
country: Germany
facility: 28
city: Koeln
country: Germany
facility: 40
city: Leipzig
country: Germany
facility: 38
city: Magdeburg
country: Germany
facility: 52
city: Mainz
country: Germany
facility: 67
city: Mittweida
country: Germany
facility: 49
city: München
country: Germany
facility: 01
city: Oranienburg
country: Germany
facility: 08
city: Osnabrück
country: Germany
facility: 17
city: Radeberg
country: Germany
facility: 14
city: Rüsselsheim
country: Germany
facility: 15
city: Senftenberg
country: Germany
facility: 16
city: Stuttgart
country: Germany
facility: 41
city: Troisdorf
country: Germany
facility: 09
city: Tübingen
country: Germany
facility: 22
city: Ulm
country: Germany
facility: 20
city: Westerstede
country: Germany
facility: 07
Study officials:
affiliation: UCB Pharma
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References: