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

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.

Study Overview

• Status: Completed
• Conditions: Epilepsies, Partial

• Study Type: Observational
• Enrollment (Actual): 576

Contacts and Locations

Study Locations

• Germany
  • Aachen, Germany
    • 55
  • Aalen, Germany
    • 119
  • Aichach, Germany
    • 194
  • Altenburg, Germany
    • 191
  • Alzenau, Germany
    • 136
  • Aschaffenburg, Germany
    • 78
  • Bad Berka, Germany
    • 35
  • Baesweiler, Germany
    • 90
  • Berlin, Germany
    • 66
  • Berlin, Germany
    • 25
  • Berlin, Germany
    • 107
  • Berlin, Germany
    • 10A
  • Berlin, Germany
    • 141
  • Berlin, Germany
    • 49
  • Berlin, Germany
    • 75
  • Bielefeld, Germany
    • 36
  • Bonn, Germany
    • 5
  • Brandenburg, Germany
    • 175
  • Böblingen, Germany
    • 192
  • Chemnitz, Germany
    • 105
  • Coppenbrügge, Germany
    • 182
  • Dortmund, Germany
    • 161
  • Dresden, Germany
    • 128
  • Dresden, Germany
    • 21
  • Dresden, Germany
    • 39
  • Düren, Germany
    • 111
  • Düsseldorf, Germany
    • 38
  • Eberswalde, Germany
    • 7
  • Eisenach, Germany
    • 102
  • Eisenach, Germany
    • 174
  • Ellwangen, Germany
    • 56
  • Erbach, Germany
    • 50
  • Erfurt, Germany
    • 179
  • Erfurt, Germany
    • 186
  • Erlangen, Germany
    • 6
  • Essen, Germany
    • 12
  • Freiburg, Germany
    • 27
  • Fulda, Germany
    • 137
  • Gelsenkirchen, Germany
    • 112
  • Gera, Germany
    • 103
  • Greifswald, Germany
    • 1
  • Grevenbroich, Germany
    • 47
  • Göttingen, Germany
    • 158
  • Göttingen, Germany
    • 65
  • Göttingen, Germany
    • 88
  • Halle (Saale), Germany
    • 134
  • Hamburg, Germany
    • 71
  • Hamburg, Germany
    • 160
  • Hamm, Germany
    • 93
  • Heilbronn, Germany
    • 147
  • Herborn, Germany
    • 122
  • Herdecke, Germany
    • 15
  • Höchberg, Germany
    • 130
  • Immenstadt, Germany
    • 40
  • Jena, Germany
    • 52
  • Jülich, Germany
    • 61
  • Karlstadt, Germany
    • 44
  • Kastellaun, Germany
    • 133
  • Kaufbeuren, Germany
    • 125
  • Kiel, Germany
    • 16
  • Kleve, Germany
    • 99
  • Krefeld, Germany
    • 37
  • Köln, Germany
    • 176
  • Köln, Germany
    • 180
  • Lappersdorf, Germany
    • 46
  • Leipzig, Germany
    • 113
  • Leipzig, Germany
    • 4
  • Leipzig, Germany
    • 68
  • Leipzig, Germany
    • 81
  • Lohr am Main, Germany
    • 138
  • Ludwigsburg, Germany
    • 131
  • Lüdenscheid, Germany
    • 148
  • Mainz, Germany
    • 33
  • Mannheim, Germany
    • 154
  • Mühlhausen, Germany
    • 151
  • München, Germany
    • 101
  • München, Germany
    • 167
  • München, Germany
    • 2
  • Neuburg, Germany
    • 43
  • Neukirchen-Vluyn, Germany
    • 62
  • Neumarkt, Germany
    • 123
  • Nürnberg, Germany
    • 69
  • Oelde, Germany
    • 80
  • Oldenburg, Germany
    • 98
  • Oranienburg, Germany
    • 87
  • Potsdam, Germany
    • 57
  • Radeberg, Germany
    • 3
  • Rathenow, Germany
    • 159
  • Ravensburg, Germany
    • 45
  • Rostock, Germany
    • 95
  • Rüsselsheim, Germany
    • 85
  • Schleswig, Germany
    • 20
  • Schlüchtern, Germany
    • 157
  • Schorndorf, Germany
    • 166
  • Schriesheim, Germany
    • 181
  • Schwedt, Germany
    • 168
  • Schwäb. Gmünd, Germany
    • 150
  • Senftenberg, Germany
    • 140
  • Siegen, Germany
    • 164
  • Sondershausen, Germany
    • 144
  • Stralsund, Germany
    • 127
  • Stuttgart, Germany
    • 14
  • Stuttgart, Germany
    • 170
  • Traunstein, Germany
    • 104
  • Troisdorf, Germany
    • 183
  • Tübingen, Germany
    • 17
  • Ulm, Germany
    • 13
  • Ulm, Germany
    • 48
  • Unterhaching, Germany
    • 54
  • Wermsdorf, Germany
    • 171
  • Westerstede, Germany
    • 143
  • Wismar, Germany
    • 79
  • Wolfratshausen, Germany
    • 169

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Number (Frequency) of Partial-onset Seizures Without Secondary Generalization 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.	From Baseline to Month 3
Change in Number (Frequency) of Partial-onset Seizures Without Secondary Generalization 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.	From Baseline to Month 6
Change in Number (Frequency) of Seizures With Secondary Generalization 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.	From Baseline to Month 3
Change in Number (Frequency) of Seizures With Secondary Generalization 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.	From Baseline to Month 6
Incidence of Adverse Events During the Study	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.	From Inclusion Visit (Day 0) up to Month 6

Collaborators and Investigators

• Sponsor: UCB Pharma GmbH

Publications and helpful links

General Publications

• 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.

Helpful Links

• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: April 1, 2010
• First Submitted That Met QC Criteria: April 1, 2010
• First Posted (Estimate): April 2, 2010

Study Record Updates

• Last Update Posted (Estimate): September 3, 2014
• Last Update Submitted That Met QC Criteria: August 22, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: Epilepsy; Partial-Onset Seizures; Adjunctive therapy; Lacosamide; Vimpat®
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy; Epilepsies, Partial
• Other Study ID Numbers: SP0973