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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Levetiracetam and Pregabalin for Monotherapy in Patients With Brain Tumors and Seizures. A Phase II Randomized Study.

Conditions
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Brain and Central Nervous System Tumors, Seizure

Intervention / Treatment
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* Drug: levetiracetam
* Drug: pregabalin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Levetiracetam<br>Patients assigned to Levetiracetam are treated with the initial dose of 2 x 250mg per day up to one year | Drug: pregabalin<br>* 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.<br>|
| Active Comparator: Pregabalin<br>Patients assigned to Pregabalin are treated with the initial dose of 2 x 75mg per day up to one year | Drug: levetiracetam<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | baseline to visit at 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | baseline to visit at 12 months | 
| Anxiety |  | baseline to visit at 12 months | 
| Need to add a second AED |  | baseline to visit at 12 months | 
| Study drug discontinuation |  | baseline to visit at 12 months | 
| Occurrence of consciousness-impairing seizures or status epilepticus |  | baseline to visit at 12 months | 
| Mortality |  | baseline to visit at 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adult pineoblastoma, seizure, adult anaplastic astrocytoma, adult diffuse astrocytoma, adult pineal gland astrocytoma, adult glioblastoma, adult gliosarcoma, adult giant cell glioblastoma, adult brain stem glioma, adult ependymoblastoma, adult medulloblastoma, adult supratentorial primitive neuroectodermal tumor (PNET), adult ependymoma, adult anaplastic ependymoma, adult anaplastic meningioma, adult anaplastic oligodendroglioma, adult oligodendroglioma, adult pineocytoma, adult mixed glioma, adult papillary meningioma, recurrent adult brain tumor, adult grade II meningioma