Cannabidiol in patients with seizures associated with Lennox-Gastaut syndrome (GWPCARE4): a randomised, double-blind, placebo-controlled phase 3 trial
Cannabidiol in patients with seizures associated with Lennox-Gastaut syndrome (GWPCARE4): a randomised, double-blind, placebo-controlled phase 3 trial
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DOI：
10.1016/s0140-6736(18)30136-3
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发表时间：
2018-03-17
期刊：
影响因子：
168.9
通讯作者：
Sommerville, Kenneth
中科院分区：
文献类型：
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作者：
Thiele, Elizabeth A.;Marsh, Eric D.;Sommerville, Kenneth
背景Lennox-Gastaut综合征是一种罕见、严重的癫痫脑病，患者经常对可用的药物治疗产生抗药性。没有对照研究调查大麻二醇用于与Lennox-Gastaut综合征相关的癫痫患者。因此，我们评估了大麻二醇作为附加抗惊厥疗法在这一人群中的有效性和安全性。方法在美国、荷兰和波兰的24个临床地点进行的这项随机、双盲、安慰剂对照试验中，我们调查了大麻二醇作为附加疗法治疗难治性Lennox-Gastaut综合征患者的疗效。符合条件的患者(年龄2-55岁)患有Lennox-Gastaut综合征，包括慢(
Background Patients with Lennox-Gastaut syndrome, a rare, severe form of epileptic encephalopathy, are frequently treatment resistant to available medications. No controlled studies have investigated the use of cannabidiol for patients with seizures associated with Lennox-Gastaut syndrome. We therefore assessed the efficacy and safety of cannabidiol as an add-on anticonvulsant therapy in this population of patients.Methods In this randomised, double-blind, placebo-controlled trial done at 24 clinical sites in the USA, the Netherlands, and Poland, we investigated the efficacy of cannabidiol as add-on therapy for drop seizures in patients with treatment-resistant Lennox-Gastaut syndrome. Eligible patients (aged 2-55 years) had Lennox-Gastaut syndrome, including a history of slow (