Vimpat® Added as Adjunctive Therapy to One Baseline Antiepileptic Drug
- Conditions
- Epilepsies, Partial
- Registration Number
- NCT01098162
- Lead Sponsor
- UCB Pharma GmbH
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 576
- 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®
In accordance with the Summary of Product Characteristics (SmPC)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical Global Impression of Change (CGI-C) at Month 6 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
- Secondary Outcome Measures
Name Time Method Change in Number (Frequency) of Partial-onset Seizures Without Secondary Generalization From Baseline to Month 6 From Baseline to Month 6 Baseline values for the seizure frequency (SF) during the 12 weeks time period prior to inclusion ('historical baseline'), and the post-baseline values of seizure frequency reported after 6 months were normalized to a 28 days interval.
Change in number of partial-onset seizures was derived as follows:
Change in SF per 28 days = (SF at 6 months per 28 days) - (SF at Baseline per 28 days).
A negative value in change from Baseline means that the value has decreased from Baseline to Month 6.
Partial-onset seizures can be classified into one of the following three groups:
* Simple partial seizures
* Complex partial seizures
* Partial seizures evolving to secondarily generalized seizures.Change in Number (Frequency) of Seizures With Secondary Generalization From Baseline to Month 3 From Baseline to Month 3 Baseline values for the seizure frequency (SF) during the 12 weeks time period prior to inclusion ('historical baseline'), and the post-baseline values of seizure frequency reported after 3 months were normalized to a 28 days interval.
Change in number of partial-onset seizures with secondary generalization was derived as follows:
Change in SF per 28 days = (SF at 3 months per 28 days) - (SF at Baseline per 28 days).
A negative value in change from Baseline means that the value has decreased from Baseline to Month 3.
Partial-onset seizures with secondary generalization can be classified into one of the following three groups:
* Simple partial seizures evolving to generalized seizures
* Complex partial seizures evolving to generalized seizures
* Simple partial seizures evolving to Complex partial seizures evolving to generalized seizures.Incidence of Adverse Events During the Study From Inclusion Visit (Day 0) up to Month 6 The number of subjects affected by any Treatment Emergent Adverse Event (TEAE) during the course of the study from Day 0 up to Month 6 is presented below.
Change in Number (Frequency) of Partial-onset Seizures Without Secondary Generalization From Baseline to Month 3 From Baseline to Month 3 Baseline values for the seizure frequency (SF) during the 12 weeks time period prior to inclusion ('historical baseline'), and the post-baseline values of seizure frequency reported after 3 months were normalized to a 28 days interval.
Change in number of partial-onset seizures was derived as follows:
Change in SF per 28 days = (SF at 3 months per 28 days) - (SF at Baseline per 28 days).
A negative value in change from Baseline means that the value has decreased from Baseline to Month 3.
Partial-onset seizures can be classified into one of the following three groups:
* Simple partial seizures
* Complex partial seizures
* Partial seizures evolving to secondarily generalized seizures.Change in Number (Frequency) of Seizures With Secondary Generalization From Baseline to Month 6 From Baseline to Month 6 Baseline values for the seizure frequency (SF) during the 12 weeks time period prior to inclusion ('historical baseline'), and the post-baseline values of seizure frequency reported after 6 months were normalized to a 28 days interval.
Change in number of partial-onset seizures with secondary generalization was derived as follows:
Change in SF per 28 days = (SF at 6 months per 28 days) - (SF at Baseline per 28 days).
A negative value in change from Baseline means that the value has decreased from Baseline to Month 6.
Partial-onset seizures with secondary generalization can be classified into one of the following three groups:
* Simple partial seizures evolving to generalized seizures
* Complex partial seizures evolving to generalized seizures
* Simple partial seizures evolving to Complex partial seizures evolving to generalized seizures.
Trial Locations
- Locations (113)
13
🇩🇪Ulm, Germany
99
🇩🇪Kleve, Germany
36
🇩🇪Bielefeld, Germany
192
🇩🇪Böblingen, Germany
21
🇩🇪Dresden, Germany
175
🇩🇪Brandenburg, Germany
14
🇩🇪Stuttgart, Germany
75
🇩🇪Berlin, Germany
55
🇩🇪Aachen, Germany
7
🇩🇪Eberswalde, Germany
102
🇩🇪Eisenach, Germany
68
🇩🇪Leipzig, Germany
57
🇩🇪Potsdam, Germany
1
🇩🇪Greifswald, Germany
168
🇩🇪Schwedt, Germany
65
🇩🇪Göttingen, Germany
134
🇩🇪Halle (Saale), Germany
45
🇩🇪Ravensburg, Germany
81
🇩🇪Leipzig, Germany
148
🇩🇪Lüdenscheid, Germany
151
🇩🇪Mühlhausen, Germany
69
🇩🇪Nürnberg, Germany
3
🇩🇪Radeberg, Germany
49
🇩🇪Berlin, Germany
167
🇩🇪München, Germany
5
🇩🇪Bonn, Germany
161
🇩🇪Dortmund, Germany
194
🇩🇪Aichach, Germany
78
🇩🇪Aschaffenburg, Germany
20
🇩🇪Schleswig, Germany
16
🇩🇪Kiel, Germany
125
🇩🇪Kaufbeuren, Germany
176
🇩🇪Köln, Germany
4
🇩🇪Leipzig, Germany
138
🇩🇪Lohr am Main, Germany
131
🇩🇪Ludwigsburg, Germany
87
🇩🇪Oranienburg, Germany
113
🇩🇪Leipzig, Germany
154
🇩🇪Mannheim, Germany
123
🇩🇪Neumarkt, Germany
15
🇩🇪Herdecke, Germany
101
🇩🇪München, Germany
2
🇩🇪München, Germany
159
🇩🇪Rathenow, Germany
62
🇩🇪Neukirchen-Vluyn, Germany
33
🇩🇪Mainz, Germany
43
🇩🇪Neuburg, Germany
150
🇩🇪Schwäb. Gmünd, Germany
140
🇩🇪Senftenberg, Germany
54
🇩🇪Unterhaching, Germany
107
🇩🇪Berlin, Germany
10A
🇩🇪Berlin, Germany
66
🇩🇪Berlin, Germany
105
🇩🇪Chemnitz, Germany
182
🇩🇪Coppenbrügge, Germany
128
🇩🇪Dresden, Germany
111
🇩🇪Düren, Germany
38
🇩🇪Düsseldorf, Germany
174
🇩🇪Eisenach, Germany
56
🇩🇪Ellwangen, Germany
50
🇩🇪Erbach, Germany
179
🇩🇪Erfurt, Germany
186
🇩🇪Erfurt, Germany
6
🇩🇪Erlangen, Germany
12
🇩🇪Essen, Germany
137
🇩🇪Fulda, Germany
103
🇩🇪Gera, Germany
47
🇩🇪Grevenbroich, Germany
158
🇩🇪Göttingen, Germany
160
🇩🇪Hamburg, Germany
40
🇩🇪Immenstadt, Germany
93
🇩🇪Hamm, Germany
147
🇩🇪Heilbronn, Germany
122
🇩🇪Herborn, Germany
71
🇩🇪Hamburg, Germany
52
🇩🇪Jena, Germany
61
🇩🇪Jülich, Germany
44
🇩🇪Karlstadt, Germany
133
🇩🇪Kastellaun, Germany
37
🇩🇪Krefeld, Germany
180
🇩🇪Köln, Germany
46
🇩🇪Lappersdorf, Germany
80
🇩🇪Oelde, Germany
98
🇩🇪Oldenburg, Germany
95
🇩🇪Rostock, Germany
85
🇩🇪Rüsselsheim, Germany
157
🇩🇪Schlüchtern, Germany
166
🇩🇪Schorndorf, Germany
181
🇩🇪Schriesheim, Germany
17
🇩🇪Tübingen, Germany
164
🇩🇪Siegen, Germany
79
🇩🇪Wismar, Germany
144
🇩🇪Sondershausen, Germany
104
🇩🇪Traunstein, Germany
171
🇩🇪Wermsdorf, Germany
127
🇩🇪Stralsund, Germany
170
🇩🇪Stuttgart, Germany
48
🇩🇪Ulm, Germany
143
🇩🇪Westerstede, Germany
119
🇩🇪Aalen, Germany
191
🇩🇪Altenburg, Germany
136
🇩🇪Alzenau, Germany
35
🇩🇪Bad Berka, Germany
90
🇩🇪Baesweiler, Germany
141
🇩🇪Berlin, Germany
25
🇩🇪Berlin, Germany
39
🇩🇪Dresden, Germany
112
🇩🇪Gelsenkirchen, Germany
88
🇩🇪Göttingen, Germany
169
🇩🇪Wolfratshausen, Germany
183
🇩🇪Troisdorf, Germany
130
🇩🇪Höchberg, Germany
27
🇩🇪Freiburg, Germany