Study of Lacosamide as an Adjunctive Drug Treatment for Epilepsy in Patients With Brain Tumors (VIBES)

UCB

Status

Completed

Conditions

Brain Tumor Related Epilepsy (BTRE)

Study type

Observational

Funder types

Industry

Identifiers

NCT02276053

EP0045

Details and patient eligibility

About

This study is being conducted to find out whether lacosamide (a drug to treat epilepsy) is effective in routine clinical practice for patients with epilepsy caused by a brain tumor.

Enrollment

93 patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient has never been treated with lacosamide (LCM) prior to this non-interventional study (NIS) or treatment with LCM for the first time started no earlier than 7 days prior to enrollment in this NIS
The decision by the treating physician to prescribe LCM falls within current standard clinical practice, and the treatment decision is clearly separated from the decision to consider inclusion of the patient in the NIS
A Patient Data Consent form is signed and dated by the patient and/or by the parent(s) or legal representative
Patient is a male or female ≥ 16 years of age
Patient must have a diagnosis of brain tumor-related epilepsy (BTRE) secondary to low-grade glioma (World Health Organization Grade 1 to 2 at time of enrollment)
Patient has a retrospective Baseline seizure frequency of at least 1 partial-onset seizure in the 8 weeks prior to Visit 1 (enrollment/ Baseline visit)
Patient does not have a previous diagnosis of epilepsy before tumor onset
Patient does not have brain metastases
Patient has a Karnofsky performance status scale index ≥ 60 %
Patient is currently taking only 1-2 Baseline anti-epileptic drugs (AEDs) for epilepsy, other than LCM
Patient has received a maximum of 4 different lifetime AEDs ever before entering the NIS