N/A
Completed N=573
Vimpat® Added as Adjunctive Therapy to One Baseline Antiepileptic Drug
Epilepsies, Partial
Source: ClinicalTrials.gov NCT01098162 ↗
Enrolled (actual)
573
Serious AEs
9.8%
Results posted
Jul 2014
Primary outcomePrimary: Clinical Global Impression of Change (CGI-C) at Month 6 — 160; 179; 66; 72 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Global Impression of Change (CGI-C) at Month 6 |
160; 179; 66; 72; 16; 9 | — |
| SECONDARY Change in Number (Frequency) of Partial-onset Seizures Without Secondary Generalization From Baseline to Month 3 |
-3.80 | — |
| SECONDARY Change in Number (Frequency) of Partial-onset Seizures Without Secondary Generalization From Baseline to Month 6 |
-4.24 | — |
| SECONDARY Change in Number (Frequency) of Seizures With Secondary Generalization From Baseline to Month 3 |
-0.39 | — |
| SECONDARY Change in Number (Frequency) of Seizures With Secondary Generalization From Baseline to Month 6 |
-0.39 | — |
| SECONDARY Incidence of Adverse Events During the Study |
277 | — |
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT01098162). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.