Levetiracetam or Pregabalin in Treating Seizures in Patients Undergoing Chemotherapy and/or Radiation Therapy For Primary Brain Tumors

Dr Andrea Rossetti52 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Brain and Central Nervous System Tumors Seizure

Interventions

levetiracetamDRUG

After inclusion, patients receive Levetiracetam 2x250mg per day. The medication may be increased, in intervals of 500mg of Levetiracetam of at least 24h up to maximally: Levetiracetam 2x1500mg. Patients might be treated up to one year within the study. If well tolerated, treatment might continue after end of study.

pregabalinDRUG

After inclusion, patients receive Pregabalin 2x75mg per day. The medication may be increased, in intervals of 150mg of Pregabalin of at least 24h up to maximally: Pregabalin 2x300mg. Patients might be treated up to one year within the study. If well tolerated, treatment might continue after end of study.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

DISEASE CHARACTERISTICS: * Diagnosis of primary brain tumor * WHO grade II-IV disease * Undergoing chemotherapy and/or radiotherapy * No brain tumor without the potential need for chemotherapy (e.g., meningioma without anaplastic features) * Has had at least one seizure provoked by the brain tumor, justifying introduction of antiepileptic drug (AED) treatment * No status epilepticus PATIENT CHARACTERISTICS: * Modified Rankin score \< 4 at study enrollment * Life expectancy ≥ 4 weeks * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception * No known intolerance to the study drugs * No pre-existing psychosis and/or current suicidality PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No concurrent IV AEDs other than benzodiazepines * Other concurrent AEDs, except phenobarbital, allowed provided they are discontinued within 2 weeks after study enrollment

Locations (2)

Centre Hospitalier Universitaire Vaudois

Lausanne, Switzerland

USZ

Zurich, Switzerland

Outcomes

Primary Outcomes

Survival without occurrence of status epilepticus, 2 seizures with consciousness impairment, need to add a second antiepileptic drug (AED) (except transitory benzodiazepine), and need to discontinue study drug for lack of efficacy or adverse events