An Open Label Conversion Study of Carbidopa-Levodopa (CD-LD) Extended-Release Taken Alone or in Combination With CD-LD Immediate Release to IPX066 Followed by an Open-Label Extension Safety Study of IPX066 in Advanced PD
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 8
- 主要终点
- Clinical Global Impression (CGI)
研究概览
简要总结
The study had three distinct parts and is described as follows:
Part 1:
- To evaluate the dose conversion from CD-LD ER taken alone or in combination with CD-LD IR to IPX066 in subjects with advanced PD
- To evaluate the utility of the Objective Parkinson's Disease Measurement (OPDM), an exploratory computer-based system, in assessing dexterity and mobility in a subset of PD subjects.
Part 2:
• To evaluate the long-term safety and clinical utility of IPX066 under open-label conditions in eligible subjects who successfully completed Part 1 of the study.
Part 3:
• To further evaluate the long-term safety of IPX066 in eligible subjects who successfully completed Part 2.
详细描述
Part 1: This study was a multicenter, open-label study. Subjects were to be converted from their previous CD-LD treatment to IPX066 over a 6-week period. Up to 40 subjects were to be enrolled in the study. Enrollment was defined as subjects who received study drug in Part 1 - Visit 1. Subjects were to be entered into one of two cohorts.
Approximately 24 subjects were to enroll in Cohort 1 (non-OPDM subjects) and up to 16 subjects at selected sites were to enroll in Cohort 2 (OPDM subjects). For the subjects enrolled in Cohort 2, along with the OPDM measurements, PK blood samples were also to be collected.
Part 2: Following the successful completion of Part 1 of the study, eligible subjects could participate in Part 2, a 6-month open-label extension study.
Part 3: Following the successful completion of Part 2 of the study, eligible subjects could participate in Part 3, an additional 6-month open-label extension study.
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
- •Diagnosed with idiopathic PD without any known cause for Parkinsonism.
- •At least 30 years old at the time of PD diagnosis.
- •Currently being treated with:
- •an LD dosing frequency of at least four times a day
- •at least one dose of CD-LD ER daily
- •requiring a total daily LD dose of at least 400 mg
- •stable regimen for at least 4 weeks prior to Screening
- •Concomitant therapy with amantadine, anticholinergics, selective monoamine oxidase (MAO) type B inhibitors (e.g., selegiline, rasagiline) or dopamine agonists is 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 after completing the study.
排除标准
- •Pregnant or breastfeeding
- •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.
- •Planning to take during participation in the clinical study: any controlled-release LD product, additional CD or benserazide, entacapone or tolcapone, nonselective MAO inhibitors, or antipsychotics including neuroleptic agents for the purpose of treating psychosis or bipolar disorder.
- •Any evidence of suicidal behavior within 6 months of entering the study.
- •Allergic or hypersensitive to to CD, LD, entacapone, riboflavin, Yellow Dye #5 (tartrazine), citrus fruit or grape juice.
- •History of or currently active psychosis.
- •Active or history of peptic ulcers or surgical procedure of the stomach, the small intestine or the large intestine.
- •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 and/or nontraumatic rhabdomyolysis.
- •Abnormal kidney function
- •Severe hepatic impairment.
- •Received any investigational medications during the 4 weeks prior to Screening.
- •Previously enrolled in IPX066 studies.
研究组 & 干预措施
IPX066
Subjects were to receive individualized IPX066 doses orally in an open-label manner using four dosage strengths.
干预措施: IPX066 (Drug)
结局指标
主要结局
Clinical Global Impression (CGI)
时间窗: 6 months
Clinician-reported satisfaction outcome of IPX066 using Clinical Global Impression (PGI) 7-point scale. At Part 1 Week 6; Part 2 Month 3, and Month 6 or at Early Termination, the Investigator rated how much a subject's overall condition had changed since Part 1 Visit 1 (Baseline) using 7-point scale. 1=very much worse and 7=very much improved.
Patient Global Impression (PGI)
时间窗: 6 months
At Part 1 Week 6, Part 2 Month 3 and Month 6 or at Early Termination, the subjects rated the change in their condition with IPX066 treatment from their condition prior to Part 1 Visit 1(Baseline) using Patient Global Impression (PGI) 7-point scale. 1=very much worse and 7=very much improved.
Parkinson's Disease Questionnaire-8 (PDQ-8)
时间窗: 6 months
Change from Baseline in Parkinson's disease Questionnaire-8 (PDQ-8) at End of Study or early discontinuation. The PDQ-8 is a self-reported questionnaire consisting of 8 questions regarding the subject's disease symptoms, each item ranging from 0 to 4, and the responses consist of 0=Never, 1=Occasionally, 2=Sometimes, 3=Often, and 4=Always or cannot do at all, total score ranging from 0 (never have problems/issues) to 32 (always have problems or cannot do at all).
次要结局
未报告次要终点