This trial studies how well lacosamide works in preventing seizures in participants with malignant glioma. Anti-seizure drugs, such as lacosamide, may decrease abnormal electrical activity in the brain that plays a role in developing seizures.
PRIMARY OBJECTIVES: I. To determine if prophylactic administration of Lacosamide reduces the risk of seizures in patients with high-grade glioma (HGG). SECONDARY OBJECTIVES: I. To determine the one-year risk of first seizure in this patient population. II. To evaluate patient reported symptoms. EXPLORATORY OBJECTIVES: I. To investigate clinical and electroencephalographic predictors of seizures in this patient population. II. To evaluate the occurrence of symptoms and correlate to seizure activity as well as tolerance to treatment using the MD Anderson Symptom Inventory-Brain Tumor Module (MDASI-BT) self-reporting tool. OUTLINE: Participants are randomized to 1 of 2 arms. ARM I (LACOSAMIDE): Participants receive lacosamide orally (PO) twice a day (BID) for up to 1 year. Treatment continues in the absence of disease progression or unacceptable toxicity. ARM II (PLACEBO): Participants receive a placebo PO BID for up to 1 year. Treatment continues in the absence of disease progression or unacceptable toxicity. After completion of study treatment, participants are followed up every 3 months for 5 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
37
Given PO
Given PO
M D Anderson Cancer Center
Houston, Texas, United States
Number of Participants With Seizures
Number of Participants that had seizure in a randomized, two-arm, parallel groups of post-operative participants with newly-diagnosed high-grade glioma (HGG)
Time frame: 12 months or first seizure
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