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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00629889
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Dr Andrea Rossetti
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Andrea O. Rossetti, MD
Principal Investigator Affiliation Centre Hospitalier Universitaire Vaudois
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Completed
Countries Switzerland
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Brain and Central Nervous System Tumors, Seizure
Additional Details

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.

Arms & Interventions

Arms

Active Comparator: Levetiracetam

Patients assigned to Levetiracetam are treated with the initial dose of 2 x 250mg per day up to one year

Active Comparator: Pregabalin

Patients assigned to Pregabalin are treated with the initial dose of 2 x 75mg per day up to one year

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland

Status

Address

Centre Hospitalier Universitaire Vaudois

Lausanne, , CH-1011

USZ, Zürich, Switzerland

Status

Address

USZ

Zürich, , CH-8091

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