Vimpat® Added as Adjunctive Therapy to One Baseline Antiepileptic Drug
VITOBA
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
1 other identifier
observational
576
1 country
113
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2010
Typical duration for all trials
113 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 1, 2010
CompletedFirst Posted
Study publicly available on registry
April 2, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedResults Posted
Study results publicly available
July 22, 2014
CompletedSeptember 3, 2014
August 1, 2014
3.3 years
April 1, 2010
June 24, 2014
August 22, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical Global Impression of Change (CGI-C) at Month 6
For the assessment of the Clinical Global Impression of Change (CGI-C), the investigator provided his/her assessment of the subject's clinical status compared to Baseline. He/she was asked to check the category that best describes the subject's condition over the past 6 months compared to Baseline: * Very much improved * Much improved * Minimally improved * No change * Minimally worse * Much worse * Very much worse
Month 6
Secondary Outcomes (5)
Change in Number (Frequency) of Partial-onset Seizures Without Secondary Generalization From Baseline to Month 3
From Baseline to Month 3
Change in Number (Frequency) of Partial-onset Seizures Without Secondary Generalization From Baseline to Month 6
From Baseline to Month 6
Change in Number (Frequency) of Seizures With Secondary Generalization From Baseline to Month 3
From Baseline to Month 3
Change in Number (Frequency) of Seizures With Secondary Generalization From Baseline to Month 6
From Baseline to Month 6
Incidence of Adverse Events During the Study
From Inclusion Visit (Day 0) up to Month 6
Study Arms (1)
Vimpat®
Routine treatment in accordance with the local marketing authorization for Vimpat® added to one Baseline antiepileptic drug.
Eligibility Criteria
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.
You may qualify if:
- 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 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®
You may not qualify if:
- In accordance with the Summary of Product Characteristics (SmPC)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharma GmbHlead
Study Sites (113)
55
Aachen, Germany
119
Aalen, Germany
194
Aichach, Germany
191
Altenburg, Germany
136
Alzenau in Unterfranken, Germany
78
Aschaffenburg, Germany
35
Bad Berka, Germany
90
Baesweiler, Germany
107
Berlin, Germany
10A
Berlin, Germany
141
Berlin, Germany
25
Berlin, Germany
49
Berlin, Germany
66
Berlin, Germany
75
Berlin, Germany
36
Bielefeld, Germany
5
Bonn, Germany
192
Böblingen, Germany
175
Brandenburg, Germany
105
Chemnitz, Germany
176
Cologne, Germany
180
Cologne, Germany
182
Coppenbrügge, Germany
161
Dortmund, Germany
128
Dresden, Germany
21
Dresden, Germany
39
Dresden, Germany
111
Düren, Germany
38
Düsseldorf, Germany
7
Eberswalde, Germany
102
Eisenach, Germany
174
Eisenach, Germany
56
Ellwangen, Germany
50
Erbach im Odenwald, Germany
179
Erfurt, Germany
186
Erfurt, Germany
6
Erlangen, Germany
12
Essen, Germany
27
Freiburg im Breisgau, Germany
137
Fulda, Germany
112
Gelsenkirchen, Germany
103
Gera, Germany
158
Göttingen, Germany
65
Göttingen, Germany
88
Göttingen, Germany
1
Greifswald, Germany
47
Grevenbroich, Germany
134
Halle, Germany
160
Hamburg, Germany
71
Hamburg, Germany
93
Hamm, Germany
147
Heilbronn, Germany
122
Herborn, Germany
15
Herdecke, Germany
130
Höchberg, Germany
40
Immenstadt im Allgäu, Germany
52
Jena, Germany
61
Jülich, Germany
44
Karlstadt am Main, Germany
133
Kastellaun, Germany
125
Kaufbeuren, Germany
16
Kiel, Germany
99
Kleve, Germany
37
Krefeld, Germany
46
Lappersdorf, Germany
113
Leipzig, Germany
4
Leipzig, Germany
68
Leipzig, Germany
81
Leipzig, Germany
138
Lohr a. Main, Germany
131
Ludwigsburg, Germany
148
Lüdenscheid, Germany
33
Mainz, Germany
154
Mannheim, Germany
151
Mühlhausen, Germany
101
München, Germany
167
München, Germany
2
München, Germany
43
Neuburg am Inn, Germany
62
Neukirchen-Vluyn, Germany
123
Neumarkt, Germany
69
Nuremberg, Germany
80
Oelde, Germany
98
Oldenburg, Germany
87
Oranienburg, Germany
57
Potsdam, Germany
3
Radeberg, Germany
159
Rathenow, Germany
45
Ravensburg, Germany
95
Rostock, Germany
85
Rüsselsheim am Main, Germany
20
Schleswig, Germany
157
Schlüchtern, Germany
166
Schorndorf, Germany
181
Schriesheim, Germany
150
Schwäb. Gmünd, Germany
168
Schwedt, Germany
140
Senftenberg, Germany
164
Siegen, Germany
144
Sondershausen, Germany
127
Stralsund, Germany
14
Stuttgart, Germany
170
Stuttgart, Germany
104
Traunstein, Germany
183
Troisdorf, Germany
17
Tübingen, Germany
13
Ulm, Germany
48
Ulm, Germany
54
Unterhaching, Germany
171
Wermsdorf, Germany
143
Westerstede, Germany
79
Wismar, Germany
169
Wolfratshausen, Germany
Related Publications (1)
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.
PMID: 26526971DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB Clinical Trial Call Center
- Organization
- UCB
Study Officials
- STUDY DIRECTOR
UCB Clinical Trial Call Center
+1 877 822 9493 (UCB)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 1, 2010
First Posted
April 2, 2010
Study Start
March 1, 2010
Primary Completion
July 1, 2013
Study Completion
July 1, 2013
Last Updated
September 3, 2014
Results First Posted
July 22, 2014
Record last verified: 2014-08