JPRN-jRCT2080223588已完成3 期
A Multicenter, Uncontrolled, Open-label Study and Extension Study for Verification of Efficacy and Safety for Perampanel Monotherapy in Untreated Patients With Partial Onset Seizures (Including Secondarily Generalized Seizures)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 89
研究概览
简要总结
Monotherapy treatment with perampanel at doses of 4 mg and 8 mg was effective in achieving seizure-free status for at least 26 weeks in untreated subjects with POS. Monotherapy treatment with perampanel at doses of 4 mg and 8 mg was safe and well tolerated. No new safety signals were identified for monotherapy treatment with perampanel.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 12age old 至 <= 74age old（—）
- 性别
- All
入选标准
- •(1)Be considered reliable and willing to be available for the study period and are able to record seizures and report adverse events (AEs) himself/herself or have a caregiver who can record seizures and report AEs for them
- •(2)Participants who are newly diagnosed or recurrent epilepsy
- •(3)Participants who have excluded the progressive central nervous system (CNS) abnormality occurring seizures by computed tomography (CT) or magnetic resonance imaging (MRI)
- •(4)Participants who have had a diagnosis of epilepsy with partial seizures with or without secondarily generalized seizures
排除标准
- •(1)Participants who present only simple partial seizures without motor signs
- •(2)Participants who have seizure clusters where individual seizures cannot be counted
- •(3)Participants who present or have a history of Lennox-Gastaut syndrome
- •(4)Participants who have a history of status epilepticus
- •(5)Participants who have a history of psychogenic non-epileptic seizures
研究者
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