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A Pilot Study of the Efficacy of Levetiracetam in Patients With Seizures From Brain Metastases
RATIONALE: Anticonvulsant drugs, such as levetiracetam, may help control seizures caused by brain metastases. PURPOSE: This clinical trial is studying the side effects and how well levetiracetam works in treating patients with seizures caused by brain metastases.
OBJECTIVES: * Determine the optimal dose of levetiracetam required to control seizures from brain metastases in patients with solid tumors. * Determine the frequency of side effects and tolerability of this drug when used to control seizures in these patients. * Determine any improvement in antiepileptic drug-associated symptoms in these patients. OUTLINE: This is a pilot study. Patients are stratified according to baseline seizures (yes vs no) and/or baseline antiepileptic drugs (AEDs) (yes vs no). Patients are assigned to 1 of 3 treatment groups. * Group I (patients with no active baseline seizures): Patients receive oral levetiracetam twice daily beginning on day 1. * Group II (patients requiring IV AEDs for baseline seizure control): Patients receive oral levetiracetam (instead of their current anticonvulsant therapy) twice daily beginning on day 1, after their presenting condition has stabilized. * Group III (patients with active seizures controlled by other concurrent anticonvulsant monotherapy): Patients receive oral levetiracetam (instead of their current anticonvulsant therapy) twice daily beginning on day 1. Treatment with the other anticonvulsant drug is tapered beginning on day 3 as directed by the treating physician. In all groups, treatment continues for up to 6 months in the absence of uncontrolled seizures or unacceptable toxicities. During study therapy, patients maintain a seizure log that tracks frequency and type of seizures. Any patient who experiences a breakthrough seizure or multiple auras receives increasing doses of oral levetiracetam until the maximum dose is reached. Patients who continue to have seizures at the maximum dose level receive a second antiseizure medication at the discretion of the treating physician. Quality of life is assessed by the Fundamental Assessment of Cancer Treatment-Brain questionnaire at baseline and at 2 months. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Start Date
February 1, 2007
Primary Completion Date
July 1, 2007
Completion Date
July 1, 2007
Last Updated
May 18, 2012
levetiracetam
DRUG
quality-of-life assessment
PROCEDURE
Lead Sponsor
Northwestern University
Collaborators
NCT06700356
NCT05077904
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05667142