Ignite Creation Date:
2024-05-05 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00415376
Status:
WITHDRAWN
Last Update Posted:
2012-05-18
First Post:
2006-12-20
Brief Title:
Levetiracetam in Treating Patients With Seizures Caused by Brain Metastases
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
A Pilot Study of the Efficacy of Levetiracetam in Patients With Seizures From Brain Metastases
Status:
WITHDRAWN
Status Verified Date:
2012-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to accrue subjects
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
PURPOSE This clinical trial is studying the side effects and how well levetiracetam works in treating patients with seizures caused by brain metastases
Detailed Description:
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 andor 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
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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UCB-NU-05CC11 | None | None | None |
| NU-05CC11 | None | None | None |
| NU-1398-032 | None | None | None |