Vimpat® Added as Adjunctive Therapy to One Baseline Antiepileptic Drug

Completed

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

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 & 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): 55
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Aachen, Germany
119
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Aalen, Germany
194
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Aichach, Germany
191
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Altenburg, Germany
136
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Alzenau, Germany
78
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Aschaffenburg, Germany
35
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Bad Berka, Germany
90
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Baesweiler, Germany
107
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Berlin, Germany
10A
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Berlin, Germany
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55
🇩🇪Aachen, Germany