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Clinical Trials/NCT00650104
NCT00650104
Completed
Phase 3

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 site in 1 country76 target enrollmentMay 2002

Overview

Phase
Phase 3
Intervention
Ropinirole XL (formerly CR)
Conditions
Parkinson Disease
Sponsor
GlaxoSmithKline
Enrollment
76
Locations
1
Primary Endpoint
Unified Parkinson's Disease (PD) Rating Scale (UPDRS) Total Activities of Daily Living Scores (Intent-to-Treat Population)
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
May 2002
End Date
March 2009
Last Updated
12 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Arms & Interventions

Active

Open label medication - Ropinirole CR

Intervention: Ropinirole XL (formerly CR)

Outcomes

Primary Outcomes

Unified Parkinson's Disease (PD) Rating Scale (UPDRS) Total Activities of Daily Living Scores (Intent-to-Treat Population)

Time Frame: 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)

Time Frame: 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.

Secondary Outcomes

  • 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)

Study Sites (1)

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