Vimpat® Added as Adjunctive Therapy to One Baseline Antiepileptic Drug

NCT ID: NCT01098162

Last Updated: 2014-09-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

576 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-03-31

Study Completion Date

2013-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Epilepsies, Partial

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Vimpat®

Routine treatment in accordance with the local marketing authorization for Vimpat® added to one Baseline antiepileptic drug.

No interventions assigned to this group

Eligibility Criteria

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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)
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UCB Pharma GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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UCB Clinical Trial Call Center

Role: STUDY_DIRECTOR

+1 877 822 9493 (UCB)

Locations

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55

Aachen, , Germany

Site Status

119

Aalen, , Germany

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194

Aichach, , Germany

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191

Altenburg, , Germany

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136

Alzenau in Unterfranken, , Germany

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78

Aschaffenburg, , Germany

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35

Bad Berka, , Germany

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90

Baesweiler, , Germany

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107

Berlin, , Germany

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10A

Berlin, , Germany

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141

Berlin, , Germany

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25

Berlin, , Germany

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49

Berlin, , Germany

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66

Berlin, , Germany

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75

Berlin, , Germany

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36

Bielefeld, , Germany

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5

Bonn, , Germany

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192

Böblingen, , Germany

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175

Brandenburg, , Germany

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105

Chemnitz, , Germany

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176

Cologne, , Germany

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180

Cologne, , Germany

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182

Coppenbrügge, , Germany

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161

Dortmund, , Germany

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128

Dresden, , Germany

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21

Dresden, , Germany

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39

Dresden, , Germany

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111

Düren, , Germany

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38

Düsseldorf, , Germany

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7

Eberswalde, , Germany

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102

Eisenach, , Germany

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174

Eisenach, , Germany

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56

Ellwangen, , Germany

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50

Erbach im Odenwald, , Germany

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179

Erfurt, , Germany

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186

Erfurt, , Germany

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6

Erlangen, , Germany

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12

Essen, , Germany

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27

Freiburg im Breisgau, , Germany

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137

Fulda, , Germany

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112

Gelsenkirchen, , Germany

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103

Gera, , Germany

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158

Göttingen, , Germany

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65

Göttingen, , Germany

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88

Göttingen, , Germany

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1

Greifswald, , Germany

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47

Grevenbroich, , Germany

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134

Halle, , Germany

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160

Hamburg, , Germany

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71

Hamburg, , Germany

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93

Hamm, , Germany

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147

Heilbronn, , Germany

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122

Herborn, , Germany

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15

Herdecke, , Germany

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130

Höchberg, , Germany

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40

Immenstadt im Allgäu, , Germany

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52

Jena, , Germany

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61

Jülich, , Germany

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44

Karlstadt am Main, , Germany

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133

Kastellaun, , Germany

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125

Kaufbeuren, , Germany

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16

Kiel, , Germany

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99

Kleve, , Germany

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37

Krefeld, , Germany

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46

Lappersdorf, , Germany

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113

Leipzig, , Germany

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4

Leipzig, , Germany

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68

Leipzig, , Germany

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81

Leipzig, , Germany

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138

Lohr a. Main, , Germany

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131

Ludwigsburg, , Germany

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148

Lüdenscheid, , Germany

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33

Mainz, , Germany

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154

Mannheim, , Germany

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151

Mühlhausen, , Germany

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101

München, , Germany

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167

München, , Germany

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2

München, , Germany

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43

Neuburg am Inn, , Germany

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62

Neukirchen-Vluyn, , Germany

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123

Neumarkt, , Germany

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69

Nuremberg, , Germany

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80

Oelde, , Germany

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98

Oldenburg, , Germany

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87

Oranienburg, , Germany

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57

Potsdam, , Germany

Site Status

3

Radeberg, , Germany

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159

Rathenow, , Germany

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45

Ravensburg, , Germany

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95

Rostock, , Germany

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85

Rüsselsheim am Main, , Germany

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20

Schleswig, , Germany

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157

Schlüchtern, , Germany

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166

Schorndorf, , Germany

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181

Schriesheim, , Germany

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150

Schwäb. Gmünd, , Germany

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168

Schwedt, , Germany

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140

Senftenberg, , Germany

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164

Siegen, , Germany

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144

Sondershausen, , Germany

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127

Stralsund, , Germany

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14

Stuttgart, , Germany

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170

Stuttgart, , Germany

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104

Traunstein, , Germany

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183

Troisdorf, , Germany

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17

Tübingen, , Germany

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13

Ulm, , Germany

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48

Ulm, , Germany

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54

Unterhaching, , Germany

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171

Wermsdorf, , Germany

Site Status

143

Westerstede, , Germany

Site Status

79

Wismar, , Germany

Site Status

169

Wolfratshausen, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 26526971 (View on PubMed)

Related Links

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Other Identifiers

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SP0973

Identifier Type: -

Identifier Source: org_study_id

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