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

Phase 2

Completed

• Conditions: Brain and Central Nervous System Tumors; Seizure
• Interventions: Drug: pregabalin; Drug: levetiracetam

• Registration Number: NCT00629889
• Lead Sponsor: Dr Andrea Rossetti

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 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.

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-03-05
• Study First Submitted QC: 2008-03-05
• Study First Posted: 2008-03-06
• Primary Completion: 2012-05
• Status Verified: 2013-05
• Study Completion: 2013-05
• Last Update Submitted: 2013-05-21
• Last Update Posted: 2013-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Levetiracetam	pregabalin	Patients assigned to Levetiracetam are treated with the initial dose of 2 x 250mg per day up to one year
Pregabalin	levetiracetam	Patients assigned to Pregabalin are treated with the initial dose of 2 x 75mg per day up to one year

Primary Outcome Measures

Name	Time	Method
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	baseline to visit at 12 months

Secondary Outcome Measures

Name	Time	Method
Need to add a second AED	baseline to visit at 12 months
Adverse events	baseline to visit at 12 months
Anxiety	baseline to visit at 12 months
Study drug discontinuation	baseline to visit at 12 months
Occurrence of consciousness-impairing seizures or status epilepticus	baseline to visit at 12 months
Mortality	baseline to visit at 12 months

Trial Locations

Locations (2)

Centre Hospitalier Universitaire Vaudois; 🇨🇭 Lausanne, Switzerland

USZ; 🇨🇭 Zürich, Switzerland