Vimpat® Added as Adjunctive Therapy to One Baseline Antiepileptic Drug

Study Overview
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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.

Official Title
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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

Conditions
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Epilepsies, Partial

Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Vimpat®<br>Routine treatment in accordance with the local marketing authorization for Vimpat® added to one Baseline antiepileptic drug. | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lacosamide, Vimpat®, Epilepsy, Partial-Onset Seizures, Adjunctive therapy