A Phase IV, Prospective, Open-Label, Parallel Study Evaluating the Effect of an Adjunctive Anti-Seizure Medication Using a Glutamatergic Modulator in Patients With Focal Epilepsy and High-Grade Glioma
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Decline in Neuropsychological Function
研究概览
简要总结
This phase IV trial studies the side effects and how well perampanel works in reducing seizure frequency in patients with high-grade glioma and focal epilepsy. Perampanel is a drug used to treat seizures. Giving perampanel together with other anti-seizure drugs may work better in reducing seizure frequency in patients with high-grade glioma and focal epilepsy compared to alternate anti-seizure drugs alone.
详细描述
PRIMARY OBJECTIVE:
I. Demonstrate the efficacy and safety of perampanel (PER) on seizure frequency in adult patients with biopsy-proven high-grade glioma and focal epilepsy compared with alternate anti-seizure drugs (ASDs).
SECONDARY OBJECTIVES:
I. To assess the change in neurocognitive function and brain magnetic resonance imaging (MRI) progression over the course of PER treatment with a daily dose of 4 mg (up to -8mg) in patients with biopsy-proven high-grade glioma and focal epilepsy compared with alternate ASDs.
II. To identify a biomarker-specific response to seizure-reduction in patients treated with PER in patients with a biopsy-proven high-grade glioma (i.e., IDH-mutant versus [vs] wildtype).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •The subject, or the subject's legally acceptable representative is willing to participate in a clinical trial, provides written informed consent, and subject provides written assent, as required by the Mayo Clinic Institutional Review Board (IRB) policy involving human subjects. In the event of subject lacking the capacity or losing the ability to consent, consent will be deferred to subject's legally acceptable representative
- •Subjects that meet the following diagnostic criteria:
- •Patients with established clinical diagnoses of biopsy-proven high-grade glioma (grade II or above) and epilepsy refractory to at least 1, drug with a seizure frequency of at least 1 seizure episode per month prior to baseline visit
- •Subjects with body weight of >= 40 kg and =< 125 kg at screening
- •Adults age 18 and older
排除标准
- •Subject has serious cardiac, respiratory, renal, gastrointestinal, hematologic, or other medical condition as determined by the investigator to potentially interfere with the study
- •Subjects with glioblastoma not following Stupp protocol for treatment of glioblastoma
- •History of status epilepticus in the 6 months prior to screening or a history of seizure clusters progressing to status epilepticus
- •Past medical history of drug and/or alcohol abuse
- •Pregnant or breast-feeding
- •Subjects treated with PER prior to baseline
- •Prior felony conviction disclosed by the patient or previously stated in medical record
- •History of violent behavior
- •Clinically significant laboratory abnormality at screening or baseline visits, as determined by the investigators
- •Use of an investigational drug or device within 20 days prior to treatment day 1
- •Repeated radiation therapy for tumor regrowth
- •Subjects that plan to undergo tumor resection on or after baseline visit
- •Uncontrolled psychiatric disorder at baseline
- •Subjects who report active suicidal attempts or suicidality including subjects with a history of suicide attempts or suicidality determined to be clinically significant by investigators at screening
研究组 & 干预措施
Arm A (perampanel)
Patients receive perampanel PO QD for 40 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: Questionnaire Administration (Other)
Arm A (perampanel)
Patients receive perampanel PO QD for 40 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: Perampanel (Drug)
Arm A (perampanel)
Patients receive perampanel PO QD for 40 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: Quality-of-Life Assessment (Other)
Arm B (ASD)
Patients receive ASD per standard of care for 40 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: Anticonvulsant Agent (Drug)
Arm B (ASD)
Patients receive ASD per standard of care for 40 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: Quality-of-Life Assessment (Other)
Arm B (ASD)
Patients receive ASD per standard of care for 40 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Decline in Neuropsychological Function
时间窗: At 6 months
Chi-square and Student T-test will be used to measure differences in assessment and change during the study period.
Number of Patients With a High-grade Glioma Who Achieve a > 50% Reduction in Focal Seizures With Perampanel (PER) 4 mg Daily After Failing 1 or More Anti-seizure Drugs (ASDs)
时间窗: At 3 months
Will compare seizure frequency before and 3 months after treatment with monotherapy and adjunctive PER and use descriptive statistics to demonstrate differences in responders. A P-value \< 0.05 will be used to reflect statistical significance.
Number of Patients With a High-grade Glioma Who Achieve a > 50% Reduction in Focal Seizures With PER 4 mg Daily After Failing 1 or More ASDs
时间窗: At 6 months
Will compare seizure frequency before and 6 months after treatment with monotherapy and adjunctive PER and use descriptive statistics to demonstrate differences in responders. A P-value \< 0.05 will be used to reflect statistical significance.
Number of Participants Alive at 3 Months With High-grade Glioma Treated With PER
时间窗: At 3 months
Chi-square and Student T-test will be used to measure differences in assessment and change during the study period.
次要结局
未报告次要终点
研究者
William Tatum, DO
Principal Investigator
Mayo Clinic