NCT00415376撤回不适用
A Pilot Study of the Efficacy of Levetiracetam in Patients With Seizures From Brain Metastases
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Seizure control (lack of seizure activity)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 主要目的
- Supportive Care
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed solid tumor
- •Pathological confirmation of brain metastasis is not required provided the clinical and neuroradiographic picture is typical
- •Has had at least one prior seizure due to brain metastasis
- •PATIENT CHARACTERISTICS:
- •Life expectancy ≥ 12 weeks
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Absolute neutrophil count ≥ 1,500/mm³
- •Platelet count ≥ 100,000/mm³
- •Hemoglobin ≥ 10 g/dL
- •BUN < 5 times upper limit of normal (ULN)
- •Creatinine < 5 times ULN
- •Bilirubin < 1.5 times ULN
- •AST and ALT ≤ 3 times ULN
- •Alkaline phosphatase ≤ 2 times ULN
- •No allergy to levetiracetam
- •PRIOR CONCURRENT THERAPY:
- •Prior levetiracetam allowed provided it was initiated within the past 14 days
- •Other concurrent anticonvulsant monotherapy allowed provided therapy was initiated within the past 30 days
排除标准
- 未提供
结局指标
主要结局
Seizure control (lack of seizure activity)
次要结局
未报告次要终点
研究者
相似试验
已完成
2 期
Levetiracetam for Cramps, Spasticity and Neuroprotection in Motor Neuron DiseaseAmyotrophic Lateral SclerosisPrimary Lateral SclerosisProgressive Muscular AtrophyMotor Neuron DiseaseNCT00324454Duke University20
终止
1 期
Levetiracetam Treatment of Neonatal SeizuresNeonatal SeizuresNCT02550028Children's Hospital of Fudan University60
已完成
1 期
Efficacy of Intravenous Levetiracetam in Neonatal SeizuresNeonatal SeizuresNCT01720667Richard H. Haas280
尚未招募
3 期
Prophylactic antiseizure medication in post cardiac arrest childreCTRI/2024/05/067855All India Institute of Medical Sciences Raipur
终止
3 期
Clinical Trial : TROCC (Quick Oral Treatment of Cluster Epileptic Seizures)Drug ResistantEpilepsyNCT00376766University Hospital, Grenoble112