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

Phase 2
18 Years
Not Enrolling
Brain and Central Nervous System Tumors, Seizure

Thank you

Trial Information

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


- 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.

Inclusion Criteria


- 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


- 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


- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

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

Outcome Time Frame:

baseline to visit at 12 months

Safety Issue:


Principal Investigator

Andrea O. Rossetti, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Hospitalier Universitaire Vaudois


Switzerland: Swissmedic

Study ID:




Start Date:

February 2008

Completion Date:

May 2013

Related Keywords:

  • Brain and Central Nervous System Tumors
  • Seizure
  • 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 pineoblastoma
  • adult pineocytoma
  • adult mixed glioma
  • adult papillary meningioma
  • recurrent adult brain tumor
  • adult grade II meningioma
  • Brain Neoplasms
  • Nervous System Neoplasms
  • Seizures
  • Central Nervous System Neoplasms