Brain and Central Nervous System Tumors Clinical Trial
Official title:
Levetiracetam and Pregabalin for Monotherapy in Patients With Brain Tumors and Seizures. A Phase II Randomized Study.
RATIONALE: Levetiracetam and pregabalin are drugs that treat seizures. It is not yet known
which drug is more effective in treating seizures caused by primary brain tumors.
PURPOSE: This randomized phase II trial is studying the side effects and how well
levetiracetam or pregabalin work in treating seizures in patients undergoing chemotherapy
and/or radiation therapy for primary brain tumors.
OBJECTIVES:
- To determine the safety and efficacy of antiepileptic drug monotherapy comprising
levetiracetam or pregabalin in treating seizures in patients undergoing chemotherapy
and/or radiotherapy for primary brain tumors.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive levetiracetam.
- Arm II: Patients receive pregabalin. Patients are followed at 2 weeks, 2 months, 6
months, and then at 1 year.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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