NCT02807675已完成1 期
A Phase 1 Study of the Safety and Tolerability of a Single Dose Administration of CVT- 301 (Levodopa Inhalation Powder) When Administered for Early Morning OFF Symptoms in Patients With Parkinson's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 11
- 主要终点
- Number of patients with Adverse Events (AEs) including Serious AEs
研究概览
简要总结
This study is a double-blind, randomized, placebo-controlled, 2-way crossover study to evaluate the safety of CVT-301 levodopa (l-dopa) when co- administered with the first daily dose of oral levodopa/carbidopa for early morning OFF symptoms in patients with Parkinson's disease (PD).
详细描述
An "OFF state" is defined as the time when medication is no longer providing benefit with respect to mobility, slowness, and stiffness. OFF episodes may be heralded by non-motor symptoms (e.g., pain, anxiety) prior to the appearance of motor symptoms.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •have idiopathic PD (i.e., not induced by drugs or other diseases) as defined by fulfilling Steps 1 and 2 of the United Kingdom (UK) Brain Bank criteria, diagnosed after the age of 30 years
- •diagnosis of Parkinson's disease and motor fluctuations and early morning OFF symptoms
- •classified as Stage 1 to 3 on the modified Hoehn and Yahr scale for staging of PD severity (in an ON state)
- •subjects who are on a l-dopa-containing therapy, not including Rytary (or equivalent), must be stable on oral l-dopa-containing therapy for at least 2 weeks prior to the Screening Visit with a l-dopa/decarboxylase inhibitor (DDI)-containing regimen
- •subjects who are on a l-dopa-containing therapy, when including Rytary (or equivalent), should be on a stable dose for at least 6 weeks prior to the Screening Visit
- •the frequency of l-dopa administrations must be at least 3 times during the waking day and a total daily l-dopa dose of ≤ 1600 mg.
- •on a stable regimen of their standard PD medications
- •on a stable regimen of any blood pressure reducing medications (if applicable) for at least 30 days prior to screening
- •forced expiratory volume in one second (FEV1) ≥60% of predicted for race, age, sex, and height and FEV1/FVC (forced vital capacity) ratio ≥70%
- •no clinically significant abnormalities that would affect ability to complete study as determined by medical history, physical examination, electrocardiogram, clinical laboratory test results
- •negative drug and alcohol testing
- •negative pregnancy test for all women.
排除标准
- •participated in any prior study with CVT-301
- •dyskinesia of a severity that would significantly interfere with the subject's ability to participate or perform study procedures (as determined by the UPDRS Part 4)
- •any contraindication to performing routine spirometry or who are unable to perform a spirometry maneuver
- •have a current history of symptomatic orthostatic hypotension or are treated with medications to treat orthostatic hypotension (for example droxidopa, fludrocortisone), if they have severe dysautonomia
- •have chronic obstructive pulmonary disease (COPD), asthma, or another chronic respiratory disease within the last 5 years.
研究组 & 干预措施
CVT-301, levodopa inhalation powder (LIP)
Experimental
designed to deliver l-dopa to the lung using the CVT-301 inhaler.
干预措施: CVT-301, LIP (Drug)
Placebo
Placebo Comparator
Administered in the same way as the investigational product, except that it does not contain l-dopa.
干预措施: Placebo (Other)
结局指标
主要结局
Number of patients with Adverse Events (AEs) including Serious AEs
时间窗: up to 9 days
次要结局
- Examiner rated time to ON comparisons between treatments (CVT-301 and placebo)(day 1 and day 3)
研究者
研究点 (11)
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