A Phase 2 Efficacy, Safety and Pharmacokinetic Study of XP21279 BL2 and Sinemet® in Parkinson's Disease Subjects With Motor Fluctuations
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Change from Baseline in mean daily "off" time at end of double-blind maintenance treatment periods.
研究概览
简要总结
The purpose of the study is to assess the efficacy and safety of XP21279/Carbidopa in comparison to Sinemet as well as evaluate the pharmacokinetics (PK) of levodopa after administration of XP21279/Carbidopa and Sinemet and to explore exposure-response relationships in a subset of subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must have predictable motor fluctuations of the wearing off type, defined by meeting the following criteria based on the on/off diaries recorded over 3 days in the Screening Period:
- •Wearing-off in at least half (50%) of inter-dose intervals between the first and the last daily doses averaged over the 3 diary days, and
- •An average daily "off" time of 2 hours after the first "on" of the day through awake time up to midnight.
- •Subjects must be on one of the following stable QID or 5 times daily regimens for at least 4 weeks prior to Screening: Sinemet® or carbidopa-levodopa, with a total daily dose ranging from 400 mg to 1000 mg of levodopa
排除标准
- •History, signs, or symptoms suggesting the diagnosis of secondary or atypical Parkinsonism.
- •Subject has moderately or severely disabling dyskinesias for greater than 25% of the waking day
- •Subjects who have significant neurological symptoms not accounted for by Parkinson's disease
- •Subjects who are taking Sinemet® CR, Parcopa®, concomitant COMT inhibitors (i.e., entacapone or tolcapone), Stalevo®, or benserazide containing levodopa preparations Madopar® or Prolopa®.
研究组 & 干预措施
Treatment sequence 1
Subjects will receive XP21279 and carbidopa, Sinemet, placebo for XP21279 and carbidopa, placebo for Sinemet in a randomized sequence.
干预措施: XP21279 and carbidopa (experimental) (Drug)
Treatment sequence 1
Subjects will receive XP21279 and carbidopa, Sinemet, placebo for XP21279 and carbidopa, placebo for Sinemet in a randomized sequence.
干预措施: Sinemet (comparator) (Drug)
Treatment sequence 1
Subjects will receive XP21279 and carbidopa, Sinemet, placebo for XP21279 and carbidopa, placebo for Sinemet in a randomized sequence.
干预措施: Placebo for XP21279 and carbidopa (Drug)
Treatment sequence 1
Subjects will receive XP21279 and carbidopa, Sinemet, placebo for XP21279 and carbidopa, placebo for Sinemet in a randomized sequence.
干预措施: Placebo for Sinemet (Drug)
Treatment sequence 2
Subjects will receive XP21279 and carbidopa, Sinemet, placebo for XP21279 and carbidopa, placebo for Sinemet in a randomized sequence.
干预措施: XP21279 and carbidopa (experimental) (Drug)
Treatment sequence 2
Subjects will receive XP21279 and carbidopa, Sinemet, placebo for XP21279 and carbidopa, placebo for Sinemet in a randomized sequence.
干预措施: Sinemet (comparator) (Drug)
Treatment sequence 2
Subjects will receive XP21279 and carbidopa, Sinemet, placebo for XP21279 and carbidopa, placebo for Sinemet in a randomized sequence.
干预措施: Placebo for XP21279 and carbidopa (Drug)
Treatment sequence 2
Subjects will receive XP21279 and carbidopa, Sinemet, placebo for XP21279 and carbidopa, placebo for Sinemet in a randomized sequence.
干预措施: Placebo for Sinemet (Drug)
Treatment sequence 3
Subjects will receive XP21279 and carbidopa, Sinemet, placebo for XP21279 and carbidopa, placebo for Sinemet in a randomized sequence.
干预措施: XP21279 and carbidopa (experimental) (Drug)
Treatment sequence 3
Subjects will receive XP21279 and carbidopa, Sinemet, placebo for XP21279 and carbidopa, placebo for Sinemet in a randomized sequence.
干预措施: Sinemet (comparator) (Drug)
Treatment sequence 3
Subjects will receive XP21279 and carbidopa, Sinemet, placebo for XP21279 and carbidopa, placebo for Sinemet in a randomized sequence.
干预措施: Placebo for XP21279 and carbidopa (Drug)
Treatment sequence 3
Subjects will receive XP21279 and carbidopa, Sinemet, placebo for XP21279 and carbidopa, placebo for Sinemet in a randomized sequence.
干预措施: Placebo for Sinemet (Drug)
Treatment sequence 4
Subjects will receive XP21279 and carbidopa, Sinemet, placebo for XP21279 and carbidopa, placebo for Sinemet in a randomized sequence.
干预措施: XP21279 and carbidopa (experimental) (Drug)
Treatment sequence 4
Subjects will receive XP21279 and carbidopa, Sinemet, placebo for XP21279 and carbidopa, placebo for Sinemet in a randomized sequence.
干预措施: Sinemet (comparator) (Drug)
Treatment sequence 4
Subjects will receive XP21279 and carbidopa, Sinemet, placebo for XP21279 and carbidopa, placebo for Sinemet in a randomized sequence.
干预措施: Placebo for XP21279 and carbidopa (Drug)
Treatment sequence 4
Subjects will receive XP21279 and carbidopa, Sinemet, placebo for XP21279 and carbidopa, placebo for Sinemet in a randomized sequence.
干预措施: Placebo for Sinemet (Drug)
结局指标
主要结局
Change from Baseline in mean daily "off" time at end of double-blind maintenance treatment periods.
时间窗: 2 weeks
次要结局
- Proportion of responders ("much improved" or "very much improved") on Investigator-rated and patient-rated CGI-I at end of double-blind Maintenance Treatment periods(2 weeks)