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Completed

NCT Number: NCT00629889

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

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.

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Key information

Conditions

Brain and Central Nervous System Tumors Astrocytoma Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Ependymoma Glioblastoma Glioma Gliosarcoma Medulloblastoma Meningeal Neoplasms Meningioma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neoplasms, Vascular Tissue Nervous System Diseases Nervous System Neoplasms Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Neurologic Manifestations Oligodendroglioma Pathological Conditions, Signs and Symptoms Pinealoma Seizure Seizures Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Levetiracetam

Drug

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.

Pregabalin

Drug

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Adverse events

    Time frame: baseline to visit at 12 months

  2. Anxiety

    Time frame: baseline to visit at 12 months

  3. Need to add a second AED

    Time frame: baseline to visit at 12 months

  4. Study drug discontinuation

    Time frame: baseline to visit at 12 months

  5. Occurrence of consciousness-impairing seizures or status epilepticus

    Time frame: baseline to visit at 12 months

  6. Mortality

    Time frame: baseline to visit at 12 months

Sponsors and collaborators

Lead sponsor

Dr Andrea Rossetti

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2012
Study completion
2013
First posted
Mar 6, 2008
Registry last updated
May 22, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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