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

Information source: Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Brain and Central Nervous System Tumors; Seizure

Intervention: levetiracetam (Drug); pregabalin (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Dr Andrea Rossetti

Official(s) and/or principal investigator(s):
Andrea O. Rossetti, MD, Principal Investigator, Affiliation: Centre Hospitalier Universitaire Vaudois


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.

Clinical Details

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

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

Primary outcome: 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

Secondary outcome:

Adverse events


Need to add a second AED

Study drug discontinuation

Occurrence of consciousness-impairing seizures or status epilepticus


Detailed description: 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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.



- 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

Locations and Contacts

Centre Hospitalier Universitaire Vaudois, Lausanne CH-1011, Switzerland

USZ, Zürich CH-8091, Switzerland

Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: February 2008
Last updated: May 21, 2013

Page last updated: August 23, 2015

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