A Study To Evaluate The Safety And Efficacy Of IPX066 In Advanced Parkinson's Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 471
- 试验地点
- 72
- 主要终点
- Percentage of "Off" Time During Waking Hours at End of Study
研究概览
简要总结
This is a study to evaluate the safety and efficacy of IPX066 in advanced Parkinson's disease.
详细描述
A randomized, double-blind, active-control, parallel-group 13-week comparison of IPX066 versus regular carbidopa-levodopa (CD-LD). Prior to randomization, subjects on a stable regular LD regimen will enter a 3-week dose-adjustment period for IR CD-LD, followed by a 6-week dose-conversion period to IPX066.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with idiopathic PD.
- •At least 30 years old at the time of PD diagnosis.
- •Currently being treated with IR LD (CD-LD or benserazide-LD) and on a stable regimen of IR LD for at least 4 weeks and:
- •Requiring a total daily IR LD dose of at least 400 mg
- •Having a minimum dosing frequency of four times per day.
- •Able to differentiate "on" state from "off" state.
- •Have predictable "off" periods.
- •Amantadine, anticholinergics, selective monoamine oxidase (MAO) type B inhibitors (e.g., selegiline, rasagiline) or dopamine agonists are allowed as long as the doses and regimens have been stable for at least 4 weeks prior to Screening and the therapy is intended to be constant throughout the course of the study.
- •Agrees to use a medically acceptable method of contraception throughout the study and for 1 month afterward.
排除标准
- •Diagnosed with atypical Parkinsonism or any known secondary Parkinsonian syndrome.
- •Nonresponsive to LD therapy.
- •Prior functional neurosurgical treatment for PD (e.g., ablation or deep brain stimulation) or if such procedures are anticipated during study participation.
- •Received within 4 weeks or planning to take during participation in the clinical study: any controlled-release LD product, additional CD (e.g., Lodosyn®) or benserazide (e.g. Serazide®), catechol-O-methyl transferase inhibitors (e.g., entacapone and tolcapone), nonselective MAO inhibitors, apomorphine, and antipsychotics including neuroleptic agents for the purpose of treating psychosis or bipolar disorder.
- •Allergic to Yellow Dye #5 (tartrazine).
- •History of or currently active psychosis.
- •Active or prior medical conditions such as peptic ulcers or prior surgical (e.g., bowel) procedures that would interfere with LD absorption.
- •Active or history of narrow-angle glaucoma.
- •A history of malignant melanoma or a suspicious undiagnosed skin lesion.
- •History of myocardial infarction with residual atrial, nodal, or ventricular arrhythmias, upper gastrointestinal hemorrhage, or neuroleptic malignant syndrome and/or nontraumatic rhabdomyolysis.
- •Received any investigational medications during the 4 weeks prior to Screening.
- •Unable to swallow large pills (e.g., large vitamin pills).
- •Pregnant or breastfeeding.
- •Subjects who are unable to complete a symptom diary.
研究组 & 干预措施
IPX066
Following IR CD-LD dose adjustment and conversion to IPX066, subjects were assigned to Investigational product IPX066.
干预措施: IPX066 (Drug)
IPX066
Following IR CD-LD dose adjustment and conversion to IPX066, subjects were assigned to Investigational product IPX066.
干预措施: IR CD-LD (Drug)
IR CD-LD
Following IR CD-LD dose adjustment and conversion to IPX066, subjects were assigned to Investigational product IR CD-LD (active comparator).
干预措施: IPX066 (Drug)
IR CD-LD
Following IR CD-LD dose adjustment and conversion to IPX066, subjects were assigned to Investigational product IR CD-LD (active comparator).
干预措施: IR CD-LD (Drug)
结局指标
主要结局
Percentage of "Off" Time During Waking Hours at End of Study
时间窗: 22 weeks
Percentage of "off" time during waking hours at end of study is measured by using the Parkinson's disease diary. "Off" time describes a period when the participant experiences increased Parkinsonian symptoms (e.g. immobility or inability to move with ease)."
次要结局
- "Off" Time(22 weeks)
- "On" Time Without Troublesome Dyskinesia(22 weeks)