文摘
摘要目的:疗效和安全性Foslevodopa / Foscarbidopa和口服左旋多巴/卡比多巴高级帕金森症患者:设计阶段3,随机、双盲、Double-Dummy,积极控制12周的审判
背景:随着PD的发展,口服药物治疗可能成为症状控制的不足。Foslevodopa / foscarbidopa,正式名称为abbv - 951,是一个新的可溶性制定左旋多巴和卡比多巴高活性化合物正在开发先进的治疗PD交付作为去找找CSCI通过便携式外部泵。
设计/方法:这个阶段3,随机、双盲、double-dummy,与这些相应平行的组织,active-controlled,多中心研究包括病人(≥30年)的运动症状不再充分控制在他们当前的治疗和经验最低日均2.5 h(“关闭”每天时间(每天至少为2.0 h)。研究由筛选期,口服CD / LD稳定时间,其次是随机到12周的双盲治疗期。患者将接受24小时/天去找找CSCI foslevodopa / foscarbidopa +口服安慰剂或24小时/天去找找CSCI安慰剂加口服CD / LD的解决方案。评估包括改变从基线到第12周在“上”和“关闭”时期从PD日记、MDS-UPDRS分数,生活质量,睡眠症状,使用可穿戴设备测量PD症状。地方和系统安全性和耐受性将评估使用输液网站评价规模和不良事件监测。
结果:本研究将招收大约130名高级PD患者从估计有80网站在美国和澳大利亚(clinicaltrials.govID:NCT04380142)
结论:本研究将提供重要数据的安全性和有效性foslevodopa / foscarbidopa,一个潜在的新的先进的治疗选择,提供24小时/天通过去找找CSCI与先进的PD患者的口腔CD / LD。
披露:Facheris博士获得了个人作为一个雇员补偿AbbVie Inc . .Facheris博士收到AbbVie公司股票或所有权权益。Robieson博士已经收到AbbVie的个人作为一个雇员补偿。Robieson博士接到AbbVie股票或所有权权益。Nahome Fisseha已收到AbbVie的个人作为一个雇员补偿。Nahome Fisseha获得股票或AbbVie的所有者权益。Standaert博士已经收到个人薪酬在5000 - 9999美元的范围作为顾问Abbvie, Inc . Standaert博士已经收到个人补偿的范围为0 - 499美元作为对萨特的健康顾问。Standaert博士已经收到个人薪酬在500 - 4999美元的范围作为RTI的顾问咨询服务。Standaert博士已经收到个人补偿的范围0 - 499美元为Censa制药担任顾问。Standaert博士已经收到个人薪酬在500 - 4999美元的范围作为顾问Cerevance Inc . Standaert博士已经收到个人薪酬在5000 - 9999美元的范围为在科学咨询服务或为赛诺菲-安万特数据安全监测委员会。 Dr. Standaert has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Theravance, Inc. Dr. Standaert has received personal compensation in the range of $10,000-$49,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for International Parkinson and Movement Disorder Society. The institution of Dr. Standaert has received research support from Abbvie, Inc. The institution of Dr. Standaert has received research support from American Parkinson Disease Association. The institution of Dr. Standaert has received research support from Michael J. Fox Foundation for Parkinson Research. The institution of Dr. Standaert has received research support from Department of Defense. The institution of Dr. Standaert has received research support from National Institutes of Health. Dr. Standaert has received publishing royalties from a publication relating to health care.
