Clinical trial NCT01098162: Vimpat® Added as Adjunctive Therapy to One Baseline Antiepileptic Drug
Official title: A Non-interventional Post-marketing Study, Evaluating Seizure Control and Tolerability of Vimpat® as Adjunctive Therapy to One Baseline Antiepileptic Drug in Epilepsy Patients With Partial-onset Seizures With or Without Secondary Generalization in Daily Clinical Practice in Germany
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsies, Partial
Keywords: Lacosamide
Vimpat®
Epilepsy
Partial-Onset Seizures
Adjunctive therapy
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2010-04-02
Enrollment: 576
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Partial-Onset Seizures not sufficiently controlled with one Baseline Antiepileptic Drug (AED), treated by Epilepsy centers, clinics or office-based neurologists with adjunctive Vimpat® in routine daily practice.

Brief summary: The purpose of this study is to systematically and prospectively collect data from patients with partial-onset seizures in routine clinical practice setting receiving adjunctive Vimpat®. The observed population will be only patients with one baseline antiepileptic drug. Seizure control and tolerability data will be evaluated.


Eligibility criteria: Inclusion Criteria:

* The patient's treatment must be in accordance with the local marketing authorization (MA) for Vimpat®
* The decision to prescribe Vimpat® has to be made by the physician before and independently of his/her decision to include the patient in the study
* The Vimpat® treatment should have been started not longer than 2 weeks before study inclusion of the patient
* The patient must have a diagnosis of Epilepsy with Partial-Onset Seizures
* Based on the physician's clinical judgment, the patient's seizure activity is not controlled sufficiently on a current monotherapy and it is in the patient's best interest to be prescribed adjunctive Vimpat®

Exclusion Criteria:

In accordance with the Summary of Product Characteristics (SmPC)

Primary outcomes:
measure: Clinical Global Impression of Change (CGI-C) at Month 6
timeFrame: Month 6
Secondary outcomes:
measure: Change in Number (Frequency) of Partial-onset Seizures Without Secondary Generalization From Baseline to Month 3
timeFrame: From Baseline to Month 3
measure: Change in Number (Frequency) of Partial-onset Seizures Without Secondary Generalization From Baseline to Month 6
timeFrame: From Baseline to Month 6
measure: Change in Number (Frequency) of Seizures With Secondary Generalization From Baseline to Month 3
timeFrame: From Baseline to Month 3
measure: Change in Number (Frequency) of Seizures With Secondary Generalization From Baseline to Month 6
timeFrame: From Baseline to Month 6
measure: Incidence of Adverse Events During the Study
timeFrame: From Inclusion Visit (Day 0) up to Month 6
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: 55
city: Aalen
country: Germany
facility: 119
city: Aichach
country: Germany
facility: 194
city: Altenburg
country: Germany
facility: 191
city: Alzenau
country: Germany
facility: 136
city: Aschaffenburg
country: Germany
facility: 78
city: Bad Berka
country: Germany
facility: 35
city: Baesweiler
country: Germany
facility: 90
city: Berlin
country: Germany
facility: 107
city: Berlin
country: Germany
facility: 10A
city: Berlin
country: Germany
facility: 141
city: Berlin
country: Germany
facility: 25
city: Berlin
country: Germany
facility: 49
city: Berlin
country: Germany
facility: 66
city: Berlin
country: Germany
facility: 75
city: Bielefeld
country: Germany
facility: 36
city: Bonn
country: Germany
facility: 5
city: Brandenburg
country: Germany
facility: 175
city: Böblingen
country: Germany
facility: 192
city: Chemnitz
country: Germany
facility: 105
city: Coppenbrügge
country: Germany
facility: 182
city: Dortmund
country: Germany
facility: 161
city: Dresden
country: Germany
facility: 128
city: Dresden
country: Germany
facility: 21
city: Dresden
country: Germany
facility: 39
city: Düren
country: Germany
facility: 111
city: Düsseldorf
country: Germany
facility: 38
city: Eberswalde
country: Germany
facility: 7
city: Eisenach
country: Germany
facility: 102
city: Eisenach
country: Germany
facility: 174
city: Ellwangen
country: Germany
facility: 56
city: Erbach
country: Germany
facility: 50
city: Erfurt
country: Germany
facility: 179
city: Erfurt
country: Germany
facility: 186
city: Erlangen
country: Germany
facility: 6
city: Essen
country: Germany
facility: 12
city: Freiburg
country: Germany
facility: 27
city: Fulda
country: Germany
facility: 137
city: Gelsenkirchen
country: Germany
facility: 112
city: Gera
country: Germany
facility: 103
city: Greifswald
country: Germany
facility: 1
city: Grevenbroich
country: Germany
facility: 47
city: Göttingen
country: Germany
facility: 158
city: Göttingen
country: Germany
facility: 65
city: Göttingen
country: Germany
facility: 88
city: Halle (Saale)
country: Germany
facility: 134
city: Hamburg
country: Germany
facility: 160
city: Hamburg
country: Germany
facility: 71
city: Hamm
country: Germany
facility: 93
city: Heilbronn
country: Germany
facility: 147
city: Herborn
country: Germany
facility: 122
city: Herdecke
country: Germany
facility: 15
city: Höchberg
country: Germany
facility: 130
city: Immenstadt
country: Germany
facility: 40
city: Jena
country: Germany
facility: 52
city: Jülich
country: Germany
facility: 61
city: Karlstadt
country: Germany
facility: 44
city: Kastellaun
country: Germany
facility: 133
city: Kaufbeuren
country: Germany
facility: 125
city: Kiel
country: Germany
facility: 16
city: Kleve
country: Germany
facility: 99
city: Krefeld
country: Germany
facility: 37
city: Köln
country: Germany
facility: 176
city: Köln
country: Germany
facility: 180
city: Lappersdorf
country: Germany
facility: 46
city: Leipzig
country: Germany
facility: 113
city: Leipzig
country: Germany
facility: 4
city: Leipzig
country: Germany
facility: 68
city: Leipzig
country: Germany
facility: 81
city: Lohr am Main
country: Germany
facility: 138
city: Ludwigsburg
country: Germany
facility: 131
city: Lüdenscheid
country: Germany
facility: 148
city: Mainz
country: Germany
facility: 33
city: Mannheim
country: Germany
facility: 154
city: Mühlhausen
country: Germany
facility: 151
city: München
country: Germany
facility: 101
city: München
country: Germany
facility: 167
city: München
country: Germany
facility: 2
city: Neuburg
country: Germany
facility: 43
city: Neukirchen-Vluyn
country: Germany
facility: 62
city: Neumarkt
country: Germany
facility: 123
city: Nürnberg
country: Germany
facility: 69
city: Oelde
country: Germany
facility: 80
city: Oldenburg
country: Germany
facility: 98
city: Oranienburg
country: Germany
facility: 87
city: Potsdam
country: Germany
facility: 57
city: Radeberg
country: Germany
facility: 3
city: Rathenow
country: Germany
facility: 159
city: Ravensburg
country: Germany
facility: 45
city: Rostock
country: Germany
facility: 95
city: Rüsselsheim
country: Germany
facility: 85
city: Schleswig
country: Germany
facility: 20
city: Schlüchtern
country: Germany
facility: 157
city: Schorndorf
country: Germany
facility: 166
city: Schriesheim
country: Germany
facility: 181
city: Schwedt
country: Germany
facility: 168
city: Schwäb. Gmünd
country: Germany
facility: 150
city: Senftenberg
country: Germany
facility: 140
city: Siegen
country: Germany
facility: 164
city: Sondershausen
country: Germany
facility: 144
city: Stralsund
country: Germany
facility: 127
city: Stuttgart
country: Germany
facility: 14
city: Stuttgart
country: Germany
facility: 170
city: Traunstein
country: Germany
facility: 104
city: Troisdorf
country: Germany
facility: 183
city: Tübingen
country: Germany
facility: 17
city: Ulm
country: Germany
facility: 13
city: Ulm
country: Germany
facility: 48
city: Unterhaching
country: Germany
facility: 54
city: Wermsdorf
country: Germany
facility: 171
city: Westerstede
country: Germany
facility: 143
city: Wismar
country: Germany
facility: 79
city: Wolfratshausen
country: Germany
facility: 169
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: Runge U, Arnold S, Brandt C, Reinhardt F, Kuhn F, Isensee K, Ramirez F, Dedeken P, Lauterbach T, Noack-Rink M, Mayer T. A noninterventional study evaluating the effectiveness and safety of lacosamide added to monotherapy in patients with epilepsy with partial-onset seizures in daily clinical practice: The VITOBA study. Epilepsia. 2015 Dec;56(12):1921-30. doi: 10.1111/epi.13224. Epub 2015 Nov 3.