NCT02339064进行中（未招募）3 期
A Phase 3, Open-Label Study of the Safety, Efficacy and Tolerability of Apomorphine Administered by Continuous Subcutaneous Infusion in Advanced Parkinson's Disease Patients With Unsatisfactory Control on Available Therapy
MDD US Operations, LLC a subsidiary of Supernus Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 99 人开始时间: 2015年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Percent of daily "off" time during the waking day
研究概览
简要总结
This is a Phase 3, multicenter, open-label, safety and tolerability study of continuous apomorphine infusion in subjects with advanced Parkinson's Disease (PD) whose motor fluctuations remain unsatisfactory with levodopa (or levodopa/carbidopa) and at least one other class of drugs or mode of therapy for PD.
详细描述
This Phase 3, multicenter, open-label study will assess the long-term safety and tolerability of continuous subcutaneous infusion of apomorphine in advanced Parkinson's disease (PD) patients whose motor fluctuations remain unsatisfactory with levodopa (or levodopa/carbidopa) and at least one other class of drugs or mode of therapy for PD.
Further, this study will assess the clinical effectiveness of continuous apomorphine subcutaneous infusion in reducing "off" time in advanced PD patients and to assess the clinical effectiveness of continuous subcutaneous infusion of apomorphine in improving "on" time without resulting in an increase in troublesome dyskinesias.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Advanced idiopathic PD consistent with UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria
- •Overall motor control is unsatisfactory in the opinion of the Investigator and subject despite optimized treatment with available therapies, which must include a stable regimen of daily maintenance levodopa (or levodopa/carbidopa), and at least one of the following other classes of therapies:
- •Dopamine agonists (note: APOKYN intermittent injection is not to be considered here)
- •Monoamine oxidase B [MAO B] inhibitors
- •Catechol-O-methyltransferase (COMT) inhibitors
- •Deep brain stimulation (DBS)
- •Levodopa/carbidopa intestinal gel surgery (Duopa, Duodopa)
- •Other - amantadine at doses of up to 400 mg per day)
- •Experiences "off" periods averaging ≥3.0 hours per waking day
- •Other criteria will be discussed in detail with potential subjects by site Investigator
排除标准
- •Planned surgical intervention for the treatment of Parkinson's disease during participation in the study
- •History of hypersensitivity to apomorphine hydrochloride or any of the ingredients of APOKYN PFS, including sodium metabisulfite
- •Known, suspected, or planned pregnancy or lactation.
- •Recent history (within the previous 12 months) of alcohol or substance abuse
- •History of impulsive/compulsive behaviors primarily associated with the use of dopamine agonists
- •History of previously treated or current diagnosis of malignant melanoma
- •Exhibits certain signs and symptoms of cardiovascular disease
- •Other criteria will be discussed in detail with potential subjects by site Investigator
研究组 & 干预措施
Apomorphine infusion
Experimental
Continuous subcutaneous apomorphine infusion
干预措施: apomorphine infusion (Drug)
结局指标
主要结局
Percent of daily "off" time during the waking day
时间窗: Baseline Visit to Week 12
次要结局
- Percent daily "on" time without troublesome dyskinesias during waking day(Baseline Visit to Week 12)
- Percent of daily "off" time during the waking day(Baseline Visit to Treatment Weeks 2, 4, 8, 20, 28, 36, 44, and 52; and all Treatment Extension Period Visits)
- Parkinson's Disease Questionnaire(Baseline Visit to Treatment Weeks 2, 4, 8, 20, 28, 36, 44, and 52; and all Treatment Extension Period Visits)
- Percent of daily "on" time without dyskinesias(Baseline Visit to Treatment Weeks 2, 4, 8, 20, 28, 36, 44, and 52; and all Treatment Extension Period Visits)
- Patient Global Impression of Severity (PGI-S) and Change (PGI-C) Scale(Baseline Visit to Treatment Weeks 2, 4, 8, 20, 28, 36, 44, and 52; and all Treatment Extension Period Visits)
- Percent of daily "on" time without troublesome dyskinesias during the waking day(Baseline Visit to Treatment Weeks 2, 4, 8, 20, 28, 36, 44, and 52; and all Treatment Extension Period Visits)
- Unified Parkinson's Disease Rating Scale - Motor Score(Baseline Visit to Week 12)
- Clinical Global Impression of Severity (CGI-S) and Change (CGI-C) Scale(Baseline Visit to Treatment Weeks 2, 4, 8, 20, 28, 36, 44, and 52; and all Treatment Extension Period Visits)
- United Parkinson's Disease Rating Scale - Activities of Daily Living Score(Baseline Visit to Treatment Weeks 2, 4, 8, 20, 28, 36, 44, and 52; and all Treatment Extension Period Visits)
- Proportion of responders(Baseline Visit to Treatment Weeks 2, 4, 8, 20, 28, 36, 44, and 52; and all Treatment Extension Period Visits)
- Frequency and total dose of average daily intermittent injection APOKYN for subjects on APOKYN treatment at study entry(Baseline Visit to Treatment Weeks 2, 4, 8, 20, 28, 36, 44, and 52; and all Treatment Extension Period Visits)
研究者
研究点 (1)
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