Vimpat
Research type
Research Study
Full title
A NONINTERVENTIONAL STUDY OF VIMPAT® (LACOSAMIDE) AS ADJUNCTIVE ANTIEPILEPTIC DRUG THERPATY IN PATIENTS WITH BRAIN TUMOR-RELATED EPILEPSY (VIBES)
IRAS ID
161406
Contact name
Robin Grant
Contact email
Sponsor organisation
UCB BIOSCIENCES GmbH
Research summary
Patients with brain tumor related epilepsy (BTRE) present a complex therapeutic profile and require a unique and multidisciplinary approach. There are many factors to take into consideration, especially the management of epilepsy, which is often considered the most important risk factor for long-term disability. There are limited data available in patients with complex-to-treat diseases like BTRE, as well as limited established guidance. Lacosamide (LCM) has been shown to be efficacious and generally well tolerated in real life clinical practice, from first adjunct to later treatment lines. EP0045 is a multicenter, prospective noninterventional study conducted at specialized. The primary objective of this study is to evaluate in routine clinical practice the effectiveness of LCM added to a single antiepileptic drug (AED) in the treatment of patients with BTRE due to low-grade glioma. The secondary objective of this study is to evaluate the tolerability and quality of life (QoL) of patients with BTRE due to low-grade primary brain tumor who are treated with LCM added to a single AED. This observational study is entirely noninterventional. Patients will receive their usual medical care, which may include but is not limited to diagnostic or therapeutic procedures and medical treatment. The decision for initiating LCM therapy will be independent of study participation. No randomisation or use of placebos. The use of LCM, changes in treatment and overall management will be based on the physician normal practice.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
14/WM/1112
Date of REC Opinion
10 Sep 2014
REC opinion
Further Information Favourable Opinion