A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Investigating the Efficacy and Safety of CVT 301 (Levodopa Inhalation Powder) in Parkinson's Disease Patients With Motor Response Fluctuations (OFF Phenomena) (SPAN-PD™)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 351
- 试验地点
- 74
- 主要终点
- Unified Parkinson's Disease Rating Scale (UPDRS) Part III
研究概览
简要总结
This randomized, multicenter, placebo-controlled, double-blind study will evaluate the efficacy and safety of inhaled CVT 301 compared with placebo in PD patients experiencing motor response fluctuations (OFF phenomena) as an outpatient (i.e., at home) and in the clinic.
Patients who successfully complete this study will be eligible to enroll into a 12 month treatment extension (CVT-301-004E) study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Idiopathic Parkinson's Disease (PD) diagnosed between the ages of 30 and 85 years;
- •Hoehn and Yahr Stage 1-3 in an "on" state;
- •Require levodopa-containing medication regimen at least 3 times during the waking day;
- •Experience motor fluctuations with a minimum of 2 hours of average daily "off" time per waking day (excluding early morning "off" time) and demonstrate levodopa responsiveness;
- •Are on stable PD medication regimen;
- •Total daily LD dose <1600 mg/day;
- •Able to perform a spirometry maneuver in the ON and OFF states;
- •Normal cognition confirmed by MMSE score ≥25
排除标准
- •Pregnant or lactating females;
- •Previous surgery for PD or plan to have stereotactic surgery during the study period;
- •History of psychotic symptoms requiring treatment, or suicide ideation or attempt within last year;
- •Known contraindication to the use of levodopa;
- •Any significant condition, severe concurrent disease, abnormality or finding that would make patients unsuitable or may compromise patient safety;
- •Any contraindication to performing routine spirometry.
研究组 & 干预措施
CVT-301 Low Dose
Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration
干预措施: CVT-301 Low Dose (Drug)
CVT-301 High Dose
Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration
干预措施: CVT-301 High Dose (Drug)
Placebo
Capsules of inhalation-grade lactose used up to 5 times/day for OFF episodes for 3 months duration.
干预措施: Placebo (Other)
结局指标
主要结局
Unified Parkinson's Disease Rating Scale (UPDRS) Part III
时间窗: 30 minutes post-dose at week 12
Primary Efficacy Analysis: Change from Predose in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score at 30 Minutes post-dose at Week 12 for CVT-301 High Dose versus Placebo (ITT Population). UPDRS Part III ranges from 0 minimum to 86 maximum, with lower scores indicating better movement. Units on a scale.
次要结局
- Proportion of Patients Achieving Resolution of an OFF to an ON State Within 60 Minutes.(at week 12)
- UPDRS Part III Motor Score at 20 Minutes(at week 12)
- Proportion of Subjects Who Improved PGIC With CVT-301 vs. Placebo at Week 12(week 12)
- UPDRS Part III at 10 Min.(week 12)
- PD Patient Diary(post week 12)