Status:
COMPLETED
Levetiracetam or Pregabalin in Treating Seizures in Patients Undergoing Chemotherapy and/or Radiation Therapy For Primary Brain Tumors
Lead Sponsor:
Dr Andrea Rossetti
Conditions:
Brain and Central Nervous System Tumors
Seizure
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 p...
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 radiotherap...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00629889
Start Date
February 1 2008
End Date
May 1 2013
Last Update
May 22 2013
Active Locations (2)
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1
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, CH-1011
2
USZ
Zurich, Switzerland, CH-8091