A 12 Month, Dose-Level Blinded Study Investigating the Safety and Efficacy of CVT 301 (Levodopa Inhalation Powder) in Parkinson's Disease Patients With Motor Response Fluctuations (OFF Phenomena)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 325
- 试验地点
- 74
- 主要终点
- Pulmonary Safety of CVT-301 Change From Baseline for FEV1.
研究概览
简要总结
This study is a 12-month, dose-level blinded, multicenter study of 2 inhaled dose levels of CVT-301 for the treatment of up to 5 OFF episodes per day in PD patients experiencing motor fluctuations (OFF episodes). All patients will receive active treatment, but patients will be blinded to dose level. This will serve as an extension to the CVT-301-004 (NCT02240030) study for those patients who participated in that study and remain eligible for this study. In addition, patients who previously completed the CVT-301-003 (NCT01777555), CVT-301-009 (NCT02807675) and CVT-301-005 (NCT02352363) (observational arm completers), as well as CVT-301 naïve patients may be enrolled if they meet the CVT-301-004E eligibility criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 86 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 80 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 levodopa (LD) dose <1600 mg/day;
- •Able to perform a spirometry maneuver in the ON and OFF states
- •Normal cognition confirmed by Mini Mental State Examination (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. Patients who have had deep brain stimulation [DBS] will also be excluded unless the procedure was performed more than 6 months prior to study enrollment.
- •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 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 12 months duration
干预措施: CVT-301 (Drug)
CVT-301 High Dose
Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 12 months duration
干预措施: CVT-301 (Drug)
结局指标
主要结局
Pulmonary Safety of CVT-301 Change From Baseline for FEV1.
时间窗: Change from baseline at 52 weeks
To characterize the effects of CVT-301 on pulmonary safety, as assessed by spirometry FEV1 (forced expiratory volume in 1 second) by treatment group and Treatment Visit (TV). This study was a 12-month, dose-level blinded, multi-center study of 2 inhaled dose levels of CVT-301 for the treatment of up to 5 OFF periods per day in PD (Parkinson's Disease) patients experiencing motor fluctuations (OFF periods). Baseline is defined as the last non-missing assessment before the first dose of CVT-301 in CVT-301-004 study and as the last non-missing assessment before the first dose of CVT-301 in CVT-301-004E study for the rest of the patients.
Pulmonary Safety for CVT-301 Change From Baseline for FVC.
时间窗: Change from baseline at 52 weeks
To characterize the effects of CVT-301 on pulmonary safety, as assessed by spirometry FVC, (forced vital capacity) by treatment group and Treatment Visit (TV). This study was a 12-month, dose-level blinded, multi-center study of 2 inhaled dose levels of CVT-301 for the treatment of up to 5 OFF periods per day in PD patients experiencing motor fluctuations (OFF periods). Baseline is defined as the last non-missing assessment before the first dose of CVT-301 in CVT-301-004 study and as the last non-missing assessment before the first dose of CVT-301 in CVT-301-004E study for the rest of the patients.
Pulmonary Safety for CVT-301 Change From Baseline for (FEV1/FVC).
时间窗: Change from baseline at 52 weeks
To characterize the effects of CVT-301 on pulmonary safety, as assessed by spirometry FEV1/FVC (FEV1-forced expiratory volume in 1 second and (FVC) forced vital capacity ratio) by treatment group and Treatment Visit (TV). This study was a 12-month, dose-level blinded, multi-center study of 2 inhaled dose levels of CVT-301 for the treatment of up to 5 OFF periods per day in PD (Parkinson's Disease) patients experiencing motor fluctuations (OFF periods). Baseline is defined as the last non-missing assessment before the first dose of CVT-301 in CVT-301-004 study and as the last non-missing assessment before the first dose of CVT-301 in CVT-301-004E study for the rest of the patients.
次要结局
- Count of Patients Achieving Resolution of an OFF to an ON State Within 60 Minutes.(At Treatment Visit - TV6 (Week 52))
- Change From Baseline in OFF Time.(Change from baseline through 12 months duration of outpatient use)