An Open-Label,Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects Who Completed Study IN 11 004
试验速览
- 阶段
- 3 期
- 入组人数
- 460
- 试验地点
- 84
- 主要终点
- Unified Parkinson's Disease Rating Scale (UPDRS)
研究概览
简要总结
The purpose of this study is to allow evaluation of long-term clinical effect and safety outcome of treatment with AP-CD/LD, as well as to allow patients to benefit from extended treatment duration with AP-CD/LD after they have successfully completed the Phase 3 core study IN 11 004 ('core study', a phase III, multicenter, randomized, double-blind, double-dummy, active-controlled Phase 3 study to assess the safety and efficacy of AP CD/LD versus IR CD/LD in fluctuating PD patients).
详细描述
This will be a multi-center, global, open-label study in adult suffering from fluctuating Parkinson's disease subjects who have successfully completed the core study IN 11 004.
After signing informed consent and meeting inclusion/exclusion criteria, eligible subjects will be enrolled into a 12-month open-label extension and receive the AP-CD/LD as needed.
Efficacy and safety will be assessed throughout the study period.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who successfully completed the core study IN 11 004 and, in the opinion of the Investigator, would benefit from long-term treatment with AP-CD/LD
- •Continue to carry the diagnosis of Parkinson's disease consistent with UK brain bank criteria
- •Has a good response to Levodopa in the opinion of the investigator
- •Subjects able and willing to give written (signed and dated) informed consent to participate in the study
排除标准
- •Participation in another clinical trial other than IN 11 004 and receipt of an investigational medication other than that administered in the context of IN 11 004 within 28 days prior to the planned start of treatment
- •Previous or planned neurosurgical or Duodopa treatment for Parkinson's Disease (e.g., procedures including ablation or deep brain stimulation)
- •Non-selective monoamine oxidase (MAO) inhibitors within 28 days prior to Baseline Visit or planned administration during study participation
- •If, in the opinion of the Investigator, subject should not participate in the study
- •Women who are pregnant or nursing. Women of childbearing potential who are not willing to use a medically acceptable method of contraception.
研究组 & 干预措施
AP CD/LD
Accordion Pill™ Carbidopa/Levodopa Capsule 50/400mg , b.i.d or t.i.d or Accordion Pill™ Carbidopa/Levodopa Capsule 50/500mg , b.i.d or t.i.d
干预措施: Accordion Pill™ Carbidopa/Levodopa (Drug)
结局指标
主要结局
Unified Parkinson's Disease Rating Scale (UPDRS)
时间窗: base line ( week 1) to end of study ( week 53)
Change from Baseline to End of Study (Week 53) in Parts I-IV
次要结局
- Safety (Adverse Events, Safety laboratory, Vital signs)(One Year)
- Change in Parkinson's disease Questionnaire - 39 items (PDQ39).(Base line to end of study ( week 53))