A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) Followed by an Open-Label Safety Study of IPX066 in Advanced Parkinson's Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 24
- 主要终点
- Percentage of "OFF" Time During Waking Hours
研究概览
简要总结
This is a study to compare the efficacy of IPX066 and CLE in subjects with advanced Parkinson's disease.
详细描述
This is a randomized, double-blind, double-dummy, 2 treatment, 2-period crossover study followed by an open-label extension study period.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with idiopathic Parkinson's Disease (PD).
- •At least 30 years old at the time of PD diagnosis.
- •Currently being treated with carbidopa/levodopa/entacapone (CLE) and on a stable regimen of conventional LD for at least 4 weeks and:
- •Requiring a total daily levodopa (LD) dose of at least 400 mg
- •Having a minimum dosing frequency of four times per day.
- •Individual CD-LD or CLE doses that contain an LD dose which is a multiple of 50 mg.
- •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 of Screening or planning to take during participation in the clinical study: any controlled-release LD product, tolcapone, apomorphine, nonselective MAO inhibitors, or antipsychotics including neuroleptic agents for the purpose of treating psychosis or bipolar disorder.
- •Allergy or hypersensitivity to CD, LD, entacapone, riboflavin, Yellow Dye #5 (tartrazine), citrus fruit or grape juice.
- •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.
- •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 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-CLE-OLE
Dose conversion from CLE to IPX066, IPX066 (Part 1 Period 1), Open-label IPX066, CLE (Part 1 Period 2), OLE (Part 2)
干预措施: IPX066 (Drug)
IPX066-CLE-OLE
Dose conversion from CLE to IPX066, IPX066 (Part 1 Period 1), Open-label IPX066, CLE (Part 1 Period 2), OLE (Part 2)
干预措施: CLE (Drug)
CLE-IPX066-OLE
Dose conversion from CLE to IPX066, CLE (Part 1 Period 1), Open-label IPX066, IPX066 (Part 1 Period 2), OLE (Part 2)
干预措施: IPX066 (Drug)
CLE-IPX066-OLE
Dose conversion from CLE to IPX066, CLE (Part 1 Period 1), Open-label IPX066, IPX066 (Part 1 Period 2), OLE (Part 2)
干预措施: CLE (Drug)
结局指标
主要结局
Percentage of "OFF" Time During Waking Hours
时间窗: 3 days of data immediately prior to the end of each 2 week treatment period
Using a Parkinson's disease diary, subjects recorded a state of "asleep", "OFF", "ON without dyskinesia," "ON with non-troublesome dyskinesia," or "ON with troublesome dyskinesia" every 30 minutes over a 24-hour day for the last 3 days of each double-blind crossover treatment period. Mean percentage of "OFF" Time During Waking Hours was calculated. "Off" Time is Time when medication has worn off and is no longer providing benefit with regard to mobility, slowness, and stiffness.
次要结局
- UPDRS Part II Plus Part III(End of each double-blind treatment period.)
- Total "On" With No Troublesome Dyskinesia(3 days of data immediately prior to the end of each 2 week treatment period)
- Total "OFF" Time During Waking Hours(3 days of data immediately prior to the end of each 2 week treatment period)
- Subject Preference(End of Study (week 11))