- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00650104
Long-term Extension Study Evaluating Extended Release Ropinirole XL (Formerly Referred to as Ropinirole CR) in Patients Who Already Completed Either Study 167 or 164
May 2, 2013 updated by: GlaxoSmithKline
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
76
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arizona
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Scottsdale, Arizona, United States, 85259
- GSK Investigational Site
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California
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Los Angeles, California, United States, 90033
- GSK Investigational Site
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Oxnard, California, United States, 93030
- GSK Investigational Site
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Florida
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Miami, Florida, United States, 33136
- GSK Investigational Site
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Tampa, Florida, United States, 33606
- GSK Investigational Site
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Georgia
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Augusta, Georgia, United States, 30912
- GSK Investigational Site
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Kansas
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Kansas City, Kansas, United States, 66160
- GSK Investigational Site
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New Jersey
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Edison, New Jersey, United States, 08818
- GSK Investigational Site
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Pennsylvania
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Upland, Pennsylvania, United States, 19013
- GSK Investigational Site
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Texas
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Houston, Texas, United States, 77030
- GSK Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Active
Open label medication - Ropinirole CR
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Active Ropinirole CR tablets of 2.0mg, 4.0mg, 8.0mg where subjects can tritrate to an stable optimum dose level of either 2.0mg, 4.0mg, 6.0mg, 8.0mg, 12mg, 16mg, 20mg, or 24mg per day.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Screening; Week 4; Months 3, 9, 15, 21, 27, 33, 39, 45, 51, 57, 63, 69, 75, and 78
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Number of Participants With the Indicated Number of Adverse Events (AEs)
Time Frame: Every study visit from baseline to market availability (Month 78)
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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.
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Every study visit from baseline to market availability (Month 78)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Unified Parkinson's Disease Rating Scale (UPDRS) Total Activities of Daily Living Score (Responder Population)
Time Frame: Screening; Months 3, 9, 15, 27, 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.
|
Screening; Months 3, 9, 15, 27, and 78
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Unified Parkinson's Disease Rating Scale (UPDRS) Total Activities of Daily Living Scores (Maintained Responder Population)
Time Frame: Screening; Months 3, 9, 15, 27, 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.
|
Screening; Months 3, 9, 15, 27, and 78
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Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination Score (ITT Population)
Time Frame: Screening and Month 78
|
Two of the six UPDRS sections (Part II, Activities of Daily Living (ADL); Part III, Motor Examination) were assessed in this study.
The Motor Exam has 17 items, some of which are assessed in both the left and right extremities.
Each item has a choice of 5 responses that are numerically scored 0-4 (0 as the least severe, 4 as the most severe).
The final score is a sum of the 17 items, with some sections requiring multiple grades assigned to each extremity, and has a value ranging from 0 (no motor impairment) to 108 (severe motor impairment).
|
Screening and Month 78
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Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination Score (Reponder Population)
Time Frame: Screening and Month 78
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Two of the six UPDRS sections (Part II, Activities of Daily Living (ADL); Part III, Motor Examination) were assessed in this study.
The Motor Exam has 17 items, some of which are assessed in both the left and right extremities.
Each item has a choice of 5 responses that are numerically scored 0-4 (0 as the least severe, 4 as the most severe).
The final score is a sum of the 17 items, with some sections requiring multiple grades assigned to each extremity, and has a value ranging from 0 (no motor impairment) to 108 (severe motor impairment).
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Screening and Month 78
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Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination Score (Maintained Responder Population)
Time Frame: Screening and Month 78
|
Two of the six UPDRS sections (Part II, Activities of Daily Living (ADL); Part III, Motor Examination) were assessed in this study.
The Motor Exam has 17 items, some of which are assessed in both the left and right extremities.
Each item has a choice of 5 responses that are numerically scored 0-4 (0 as the least severe, 4 as the most severe).
The final score is a sum of the 17 items, with some sections requiring multiple grades assigned to each extremity, and has a value ranging from 0 (no motor impairment) to 108 (severe motor impairment).
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Screening and Month 78
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Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (ITT Population)
Time Frame: Week 2, Month 12, Month 78
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The Clinical Global Impression (CGI) scale comprises the following three components (CGI-Severity, CGI-Improvement, Index); where only the CGI-S and CGI-I were assessed in this study.
CGI-I is a global improvement scale that scores the clinician's view of the participant's global functioning prior to and after initiating a study medication from 1 (very much improved) to 7 (very much worse).
2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse.
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Week 2, Month 12, Month 78
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Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Responder Population)
Time Frame: Week 2, Month 12, Month 78
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The Clinical Global Impression (CGI) scale comprises the following three components (CGI-Severity, CGI-Improvement, Index); where only the CGI-S and CGI-I were assessed in this study.
CGI-I is a global improvement scale that scores the clinician's view of the participant's global functioning prior to and after initiating a study medication from 1 (very much improved) to 7 (very much worse).
2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse.
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Week 2, Month 12, Month 78
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Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Maintained Responder Population)
Time Frame: Week 2, Month 12, Month 78
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The Clinical Global Impression (CGI) scale comprises the following three components (CGI-Severity, CGI-Improvement, Index); where only the CGI-S and CGI-I were assessed in this study.
CGI-I is a global improvement scale that scores the clinician's view of the participant's global functioning prior to and after initiating a study medication from 1 (very much improved) to 7 (very much worse).
2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse.
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Week 2, Month 12, Month 78
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2002
Primary Completion (Actual)
March 1, 2009
Study Completion (Actual)
March 1, 2009
Study Registration Dates
First Submitted
March 27, 2008
First Submitted That Met QC Criteria
March 31, 2008
First Posted (Estimate)
April 1, 2008
Study Record Updates
Last Update Posted (Estimate)
May 6, 2013
Last Update Submitted That Met QC Criteria
May 2, 2013
Last Verified
April 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Parkinson Disease
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Dopamine Agonists
- Dopamine Agents
- Antiparkinson Agents
- Anti-Dyskinesia Agents
- Ropinirole
Other Study ID Numbers
- 101468/196
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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