Status:
COMPLETED
Study of Lacosamide as an Adjunctive Drug Treatment for Epilepsy in Patients With Brain Tumors
Lead Sponsor:
UCB BIOSCIENCES GmbH
Collaborating Sponsors:
PRA Health Sciences
Conditions:
Brain Tumor Related Epilepsy (BTRE)
Eligibility:
All Genders
16+ years
Brief 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.
Eligibility Criteria
Inclusion
- 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
- N/A
Key Trial Info
Start Date :
November 27 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 4 2017
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT02276053
Start Date
November 27 2014
End Date
December 4 2017
Last Update
June 1 2020
Active Locations (24)
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1
337
Lille, France
2
334
Lyon, France
3
335
Paris, France
4
491
Bonn, Germany