Levetiracetam or Pregabalin in Treating Seizures in Patients Undergoing Chemotherapy and/or Radiation Therapy For Primary Brain Tumors
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on October 04, 2010
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
Sponsored by: Centre Hospitalier Universitaire Vaudois
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.
Official title: Levetiracetam and Pregabalin for Monotherapy in Patients With Brain Tumors and Seizures. A Phase II Randomized Study.
Study design: Allocation: Randomized, 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
Need to add a second AED
Study drug discontinuation
Occurrence of consciousness-impairing seizures or status epilepticus
- 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.
- 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
- 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
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 and Contacts
Centre Hospitalier Universitaire Vaudois, Lausanne CH-1011, Switzerland; Recruiting
Andrea O. Rossetti, MD, Phone: 41-21-314-1220
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: February 2008
Last updated: November 10, 2009