Vimpat® Added as Adjunctive Therapy to One Baseline Antiepileptic Drug

UCB Pharma GmbH576 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

576

Conditions

Epilepsies, Partial

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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)

Locations (113)

Outcomes

Primary Outcomes

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

Time frame: Month 6

Secondary Outcomes

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.

Time frame: 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.

Data from ClinicalTrials.gov

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Aachen, Germany

119

Aalen, Germany

194

Aichach, Germany

191

Altenburg, Germany

136

Alzenau in Unterfranken, Germany

Aschaffenburg, Germany

Bad Berka, Germany

Baesweiler, Germany

107

Berlin, Germany

10A

Berlin, Germany

...and 103 more locations

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.

Time frame: 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.

Time frame: From Baseline to Month 6