Study of Lacosamide as an Adjunctive Drug Treatment for Epilepsy in Patients With Brain Tumors (NCT02276053) | Clinical Trial Compass
CompletedNot Applicable
Study of Lacosamide as an Adjunctive Drug Treatment for Epilepsy in Patients With Brain Tumors
France, Germany93 participantsStarted 2014-11-27
Plain-language 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.
Who can participate
Age range16 Years
SexALL
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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
What they're measuring
1
Percentage of Patients With Response at the End of the 6-month Observation Period
Timeframe: Visit 1 (Baseline) to Visit 3 (Month 6 or end of Observation Period)
2
Patient Global Impression of Change (PGIC) Rating at Visit 3
Timeframe: Visit 3 (Month 6 or end of Observation Period)