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

May 21, 2013 updated by: Dr Andrea Rossetti

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

52

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Lausanne, Switzerland, CH-1011
        • Centre Hospitalier Universitaire Vaudois
      • Zürich, Switzerland, CH-8091
        • USZ

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Levetiracetam
Patients assigned to Levetiracetam are treated with the initial dose of 2 x 250mg per day up to one year
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.
Active Comparator: Pregabalin
Patients assigned to Pregabalin are treated with the initial dose of 2 x 75mg per day up to one year
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: baseline to visit at 12 months
baseline to visit at 12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr Andrea Rossetti

Investigators

  • Principal Investigator: Andrea O. Rossetti, MD, Centre Hospitalier Universitaire Vaudois

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

March 5, 2008

First Submitted That Met QC Criteria

March 5, 2008

First Posted (Estimate)

March 6, 2008

Study Record Updates

Last Update Posted (Estimate)

May 22, 2013

Last Update Submitted That Met QC Criteria

May 21, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000586523
  • CHUV-Neurology-CePO-LEV-PGB
  • EU-20807

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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