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临床试验/NCT00650104
NCT00650104已完成3 期

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

GlaxoSmithKline1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2002年5月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

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)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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