101648/196: A Long-Term, Open-Label Continuation Study of Once Daily Administration of Ropinirole CR Tablets to Patients With Parkinson's Disease Who Completed the Previous Ropinirole CR Studies 167 or 164
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Unified Parkinson's Disease (PD) Rating Scale (UPDRS) Total Activities of Daily Living Scores (Intent-to-Treat Population)
研究概览
简要总结
The purpose of this study is to obtain information on the long-term safety, tolerability, and therapeutic benefit of extended release ropinirole XL, and to provide a mechanism for patients who participated in either Study 167 or Study 164 to continue receiving ropinirole XL if they chose to do so.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Males or non-pregnant/non-breast feeding females
- •At least 30 years of age
- •Diagnosis of idiopathic Parkinson''s disease (Hoehn & Yahr criteria)
- •Completed either Study 167 or Study 164
排除标准
- •Presence of uncontrolled psychiatric, hematological, renal, hepatic,endocrinological, neurological, cardiovascular disease or active malignancy
- •Dizziness or fainting due to orthostatic hypotension on standing
- •Significant sleep disorder
- •Drug abuse or alcoholism
研究组 & 干预措施
Active
Open label medication - Ropinirole CR
干预措施: Ropinirole XL (formerly CR) (Drug)
结局指标
主要结局
Unified Parkinson's Disease (PD) Rating Scale (UPDRS) Total Activities of Daily Living Scores (Intent-to-Treat Population)
时间窗: Screening; Week 4; Months 3, 9, 15, 21, 27, 33, 39, 45, 51, 57, 63, 69, 75, and 78
The UPDRS is a clinician-based scale used to assess the longitudinal course of PD. Two of the six sections were assessed (Part II, Activities of Daily Living (ADL); Part III, Motor Examination). Both consist of a number of items (ADL, 13 items; Motor Exam., 17 items), and each item has a choice of 5 responses that are numerically scored 0-4, with 0 as the least severe response and 4 as the most severe response. ADL final score is a sum of the 13 items and may have a value between 0 (no impairment of overall activities) and 52 (severe impairment of overall activities). LTT, long-term treatment.
Number of Participants With the Indicated Number of Adverse Events (AEs)
时间窗: Every study visit from baseline to market availability (Month 78)
AEs, defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, were collected to obtain data on the safety, tolerability, and benefit of ropinirole XL. Serious Adverse Events (SAEs), defined as AEs that are either fatal, life threatening, disabling/incapacitating, resulting in hospitalization or prolongation of a hospital stay, a congenital abnormality/birth defect, or any important medical occurrence that the investigator regards as serious based on medical judgment, were also collected. st. med., study medication.
次要结局
- Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Responder Population)(Week 2, Month 12, Month 78)
- Unified Parkinson's Disease Rating Scale (UPDRS) Total Activities of Daily Living Score (Responder Population)(Screening; Months 3, 9, 15, 27, and 78)
- Unified Parkinson's Disease Rating Scale (UPDRS) Total Activities of Daily Living Scores (Maintained Responder Population)(Screening; Months 3, 9, 15, 27, and 78)
- Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination Score (ITT Population)(Screening and Month 78)
- Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination Score (Reponder Population)(Screening and Month 78)
- Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination Score (Maintained Responder Population)(Screening and Month 78)
- Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (ITT Population)(Week 2, Month 12, Month 78)
- Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Maintained Responder Population)(Week 2, Month 12, Month 78)
