Fycompa Titration Intervals and Effects on Retention Rate
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The Percentage of Subjects Completing 52 Weeks of Adjunctive Therapy During the Maintenance Phase [Retention Rate].
研究概览
简要总结
This study will aim to improve retention and tolerability by slowing the initial titration rate of perampanel from a standard up-titration rate of 2 week intervals to a slower up-titration rate consisting of 3 week intervals. Subjects will be randomized to either perampanel, standard titration interval rate (Group A) or perampanel, slower titration interval rate (Group B).
详细描述
A total of 60 subjects with a confirmed diagnosis of either partial onset or primary generalized epilepsy will be recruited into the trial. 30 subjects will initiate perampanel at a dose of 2 mg/day and titrate upwards every 2 weeks to a target dose of 6 mg/day. Subjects in this group will be designated Group A. The remaining 30 subjects will also begin perampanel at a dose of 2 mg/day but will titrate upwards every 3 weeks to a target dose of 6 mg/day and will be designated Group B.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must provide written informed consent signed by the subject or legal guardian prior to entering the study in accordance with ICH and GCP guidelines.
- •Subject has a confirmed diagnosis of medically refractory epilepsy with or without secondary generalization for at least 12 months prior to visit
- •Subjects currently being treated with 1 to 3 antiepileptic medications with or without VNS (does not count as an AED).
- •Subjects aged 18 to
- •Subject's requiring an additional epilepsy medication due to either uncontrolled seizures and/or lack of tolerability with current epilepsy medications.
- •Can be safely treated, in the opinion of the investigator, with Fycompa.
- •Able and agrees to follow the specified titration schedule.
- •Subjects or a legal guardian who is able to communicate effectively with study personnel and considered reliable, able, willing and cooperative with regard to complying with protocol-defined requirements, including completion of the study diary.
排除标准
- •Any history of non-epileptic or psychogenic seizures.
- •Women who are currently pregnant, lactating or have plans to become pregnant in the immediate future.
- •Subjects with active suicidal ideation or behavior as evidenced by positive answers on the Columbia Suicide Severity Rating Scale (C-SSRS) or subject's with a history of suicidal ideation or attempt within 12 months.
- •Subjects with a suicidal attempt in the 12 months prior to Visit 1
- •Any clinically significant medical or psychiatric illness, psychological or behavioral problems, which in the opinion of the investigator would interfere with the subject's ability to participate in the study.
- •Subjects with severe hepatic impairment or severe renal impairment or on hemodialysis.
- •Any use of concomitant medication as listed in the drug insert, including medications known to be inducers of cytochrome P450 (CYP3A).
研究组 & 干预措施
Fycompa 2 week titration intervals
Perampanel oral tablet: 2mg by mouth every 24 hours for two weeks, then up-titrated by 2 mg every two weeks to a target dose of 6 mg/day. Minimum total daily dose = 2 mg/day. Maximum daily dose is 12 mg/day. Total daily dose will be determined by the Investigator based on tolerability and seizure control.
干预措施: Perampanel Oral Tablet (Drug)
Fycompa 3 week titration intervals
Perampanel oral tablet: 2mg by mouth every 24 hours for three weeks, then up-titrated by 2 mg every three weeks to a target dose of 6 mg/day. Minimum total daily dose = 2 mg/day. Maximum daily dose is 12 mg/day. Total daily dose will be determined by the Investigator based on tolerability and seizure control.
干预措施: Perampanel Oral Tablet (Drug)
结局指标
主要结局
The Percentage of Subjects Completing 52 Weeks of Adjunctive Therapy During the Maintenance Phase [Retention Rate].
时间窗: Up to 52 weeks
Retention rate, which indirectly measures the therapeutic tolerance, will be measured at 52 weeks in each group.
次要结局
- Incidence of Treatment-Emergent Adverse Events (TEAEs) Reported by the Subject or Observed by the Investigator [Safety and Tolerability].(Up to 52 weeks)
- Seizures Frequency Per Week(Up to 52 weeks)
研究者
Stephanie Marsh
Clinical Research Coordinator
University of Arizona