Study of Lacosamide as an Adjunctive Drug Treatment for Epilepsy in Patients With Brain Tumors
Conditions
Brain Tumor Related Epilepsy (BTRE)
Conditions: official terms
Brain Neoplasms - Epilepsy
Conditions: Keywords
Epilepsy, Brain tumor, lacosamide (LCM), Anti-Epileptic Drugs (AEDs)
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Overall Status
Recruiting
Summary
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 16 Years
Gender: Both
Criteria: 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

Exclusion Criteria:

- N/A
Locations
491
Bonn, Germany
Status: Recruiting
493
Freiburg, Germany
Status: Recruiting
492
Regensburg, Germany
Status: Recruiting
494
Tübingen, Germany
Status: Recruiting
394
Milano, Italy
Status: Recruiting
391
Perugia, Italy
Status: Recruiting
392
Rom, Italy
Status: Recruiting
393
Torino, Italy
Status: Recruiting
311
Amsterdam, Netherlands
Status: Recruiting
312
Den Haag, Netherlands
Status: Recruiting
341
Badalona, Spain
Status: Recruiting
441
Edinburgh, United Kingdom
Status: Recruiting
442
London, United Kingdom
Status: Recruiting
Start Date
November 2014
Completion Date
May 2016
Sponsors
UCB BIOSCIENCES GmbH
Source
UCB Pharma
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page