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

This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), March 2008

Sponsored by: Centre Hospitalier Universitaire Vaudois
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00629889
  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.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Seizure
Drug: levetiracetam
Drug: pregabalin
Phase II

Genetics Home Reference related topics:   pyridoxal 5'-phosphate-dependent epilepsy   

MedlinePlus related topics:   Brain Cancer    Cancer    Seizures   

ChemIDplus related topics:   Levetiracetam    Pregabalin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Supportive Care, Randomized, Open Label
Official Title:   Levetiracetam and Pregabalin for Monotherapy in Patients With Brain Tumors and Seizures. A Phase II Randomized Study.

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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 [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Adverse events [ Designated as safety issue: Yes ]
  • Anxiety [ Designated as safety issue: No ]
  • Need to add a second AED [ Designated as safety issue: No ]
  • Study drug discontinuation [ Designated as safety issue: No ]
  • Occurrence of consciousness-impairing seizures or status epilepticus [ Designated as safety issue: No ]
  • Mortality [ Designated as safety issue: Yes ]

Estimated Enrollment:   60
Study Start Date:   February 2008
Estimated Primary Completion Date:   December 2010 (Final data collection date for primary outcome measure)

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.
  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00629889

Locations
Switzerland
Centre Hospitalier Universitaire Vaudois     Recruiting
      Lausanne, Switzerland, CH-1011
      Contact: Andrea O. Rossetti, MD     41-21-314-1220        

Sponsors and Collaborators
Centre Hospitalier Universitaire Vaudois

Investigators
Principal Investigator:     Andrea O. Rossetti, MD     Centre Hospitalier Universitaire Vaudois    
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000586523, CHUV-Neurology-CePO-LEV/PGB, EU-20807
First Received:   March 5, 2008
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00629889
Health Authority:   Unspecified

Keywords provided by National Cancer Institute (NCI):
seizure  
adult anaplastic astrocytoma  
adult diffuse astrocytoma  
adult pineal gland astrocytoma  
adult glioblastoma  
adult gliosarcoma  
adult giant cell glioblastoma  
adult brain stem glioma  
adult ependymoblastoma  
adult medulloblastoma  
adult supratentorial primitive neuroectodermal tumor (PNET)  
adult ependymoma
adult anaplastic ependymoma
adult anaplastic meningioma
adult anaplastic oligodendroglioma
adult oligodendroglioma
adult pineoblastoma
adult pineocytoma
mixed gliomas
adult papillary meningioma
recurrent adult brain tumor
adult grade II meningioma

Study placed in the following topic categories:
Glioblastoma
Neuroectodermal Tumors, Primitive
Astrocytoma
Seizures
Pregabalin
Central Nervous System Diseases
Central Nervous System Neoplasms
Brain Diseases
Recurrence
Ependymoma
Signs and Symptoms
Brain Neoplasms
Neuroectodermal Tumors
Epilepsy
Medulloblastoma
Neuroepithelioma
Neurologic Manifestations
Etiracetam
Oligodendroglioma
Meningioma
Glioma
Gliosarcoma
Pinealoma
Nervous System Neoplasms

Additional relevant MeSH terms:
Nootropic Agents
Neoplasms
Neoplasms by Site
Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Pharmacologic Actions
Anticonvulsants

ClinicalTrials.gov processed this record on September 05, 2008




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