Comparison of Orally Dissolving Carbidopa/Levodopa (Parcopa) to Conventional Oral Carbidopa/Levodopa: A Single-Dose, Double-Blind, Double-Dummy, Placebo-Controlled, Crossover Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Measurement of Time in Minutes From When a Patient Was in a Clinical "Off" State, Took Their Medication and Went Into a Clinical "on" State
研究概览
简要总结
To find out if a single dose of Parcopa®, a form of levodopa that dissolves in your mouth, works faster than regular oral levodopa which is swallowed, in fluctuating PD patients.
详细描述
This is a study to compare orally dissolving levodopa (Parcopa) to the conventional immediate release oral levodopa. This is a single-dose, double-blind, placebo controlled crossover trial in participants with Parkinson disease.
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
- 31 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female between the age of 31 and 80 -Diagnosis of idiopathic Parkinson's disease for at least three years duration
- •Patients requiring levodopa for their PD
- •Good subjective response to levodopa
- •Fluctuating symptoms defined by wearing off phenomenon, any dyskinesia, and/or dose failures
- •A UPDRS -off- motor score of at least 25
- •Subjects willing to give informed consent
- •Subjects who are able and willing to comply with study procedures
- •If female of child-bearing potential, will use one of the approved birth control measures:
- •Hormonal contraceptives
- •Spermicidal and barrier
- •Intrauterine device
- •Partner sterility
排除标准
- •Subjects with evidence of significant dementia
- •Subjects with significant oral lesions
- •History of unstable cardiac disease including angina or congestive heart failure within 3 months prior to study entry
- •History of clinically significant renal disease including renal insufficiency of sufficient degree to require adjunctive treatment or dietary restrictions
- •History of clinically significant hepatic disease, including previously documented cirrhosis or hepatic insufficiency or jaundice within 3 months prior to study entry.
- •Subjects with poor response to levodopa
- •Women who are pregnant, breast-feeding, or planning to become pregnant during this study are excluded from participation due to unknown effects of the study drug on the fetus.
研究组 & 干预措施
Randomization Group b
Parcopa at equivalent dosage to subjects current stable dose
干预措施: Parcopa (Drug)
Randomization Group a
Carbidopa-levodopa (Sinemet)at subjects current stable dose
干预措施: carbidopa-levodopa (Sinemet) (Drug)
结局指标
主要结局
Measurement of Time in Minutes From When a Patient Was in a Clinical "Off" State, Took Their Medication and Went Into a Clinical "on" State
时间窗: first dose of day for each arm
Time to "on" state (benefit with regard to mobility, stiffness and slowness) with parcopa versus carbidopa/levodopa immediate release compound. This measurement is compared between Parcopa and carbidopa/levodopa wit the first morning dose of each intervention. Study duration was 2 days.
次要结局
未报告次要终点
研究者
Joseph Jankovic
Principal Investigator
Baylor College of Medicine