An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects With Parkinson's Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 617
- 试验地点
- 81
- 主要终点
- Change From Baseline in the Sum of UPDRS Part II + UPDRS Part III
研究概览
简要总结
The purpose of this study is to determine the long term safety and clinical utility of IPX066 in subjects with Parkinson's Disease.
详细描述
IPX066 is intended for chronic treatment of motor symptoms for all stages of PD. This study is designed to enroll subjects who have successfully completed one of the following studies of IPX066:
- IPX066-B08-05 (A Placebo-Controlled Study to Evaluate the Safety and Efficacy of IPX066 in Subjects with Parkinson's Disease)
- IPX066-B08-11 (A Study to Compare Pharmacokinetics and Pharmacodynamics of IPX066 to Standard Carbidopa - Levodopa)
- IPX066-B09-02 (A Study to Evaluate the Safety and Efficacy of IPX066 in Advanced Parkinson's Disease)
All participants will be given IPX066 for 9 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Each subject must meet the following inclusion criteria in order to be enrolled in the study:
- •Successful completion of studies IPX066-B08-05, IPX066-B08-11, or IPX066-B09-
- •In the opinion of the Investigator, the Parkinson's disease diagnosis is still valid and the subject remains eligible for LD therapy.
排除标准
- •Each subject must be free of the following exclusion criteria in order to be enrolled in the study:
- •Received an investigational medication other than those from an IPX066 trial within 4 weeks prior to the planned start of treatment.
- •Anticipates functional neurosurgical treatment for PD (e.g., ablation or deep brain stimulation) during study participation.
- •Received within 4 weeks prior to Baseline Visit or planning to take during study participation: nonselective monoamine oxidase (MAO) inhibitors (with the exception of rasagiline).
- •In the opinion of the Investigator, should not participate in the study.
研究组 & 干预措施
Open Label IPX066
Subjects received IPX066 95 mg, IPX066 145 mg, IPX066 195 mg, or IPX066 245 mg for approximately 9 months. The dose and dosing frequency was determined by the investigator.
干预措施: IPX066 95 mg (Drug)
Open Label IPX066
Subjects received IPX066 95 mg, IPX066 145 mg, IPX066 195 mg, or IPX066 245 mg for approximately 9 months. The dose and dosing frequency was determined by the investigator.
干预措施: IPX066 145 mg (Drug)
Open Label IPX066
Subjects received IPX066 95 mg, IPX066 145 mg, IPX066 195 mg, or IPX066 245 mg for approximately 9 months. The dose and dosing frequency was determined by the investigator.
干预措施: IPX066 195 mg (Drug)
Open Label IPX066
Subjects received IPX066 95 mg, IPX066 145 mg, IPX066 195 mg, or IPX066 245 mg for approximately 9 months. The dose and dosing frequency was determined by the investigator.
干预措施: IPX066 245 mg (Drug)
结局指标
主要结局
Change From Baseline in the Sum of UPDRS Part II + UPDRS Part III
时间窗: 9 months
Analysis of the Change from Baseline in the sum of the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living) + UPDRS Part III (Motor Examination) at End of Study. Unified Parkinson's Disease Rating Scale (UPDRS) - Four Parts Higher score values represent a worse outcome. Subscales II and III were summed: Part I: Mentation, Behavior and Mood - 4 questions 1-4 Score range: 1-16 Part II: Activities of Daily Living - 13 questions 5-17 Score range: 0-52 Part III: Motor Examination - 19 questions 18-31 and 25 total assessments Score range: 0-100 Part IV: Complications of Therapy (In the past week) - 11 questions Score range: 0-25
次要结局
- Total UPDRS Parts I-IV(9 months)
- Patient Global Impression (PGI)(9 months)