NCT00629889

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Dr Andrea Rossetti · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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

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.

Conditions

• Brain and Central Nervous System Tumors
• Seizure

Interventions

Type	Name	Description
DRUG	levetiracetam	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.
DRUG	pregabalin	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.

Timeline

• Start date: 2008-02-01
• Primary completion: 2012-05-01
• Completion: 2013-05-01
• First posted: 2008-03-06
• Last updated: 2013-05-22

Locations

2 sites across 1 country: Switzerland