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
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00650104
First received: March 27, 2008
Last updated: May 2, 2013
Last verified: April 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Parkinson Disease |
Drug: Ropinirole XL (formerly CR) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: No ]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 Outcome Measures:
- 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 ] [ Designated as safety issue: No ]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.
- 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 ] [ Designated as safety issue: No ]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.
- Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination Score (ITT Population) [ Time Frame: Screening and Month 78 ] [ Designated as safety issue: No ]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).
- Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination Score (Reponder Population) [ Time Frame: Screening and Month 78 ] [ Designated as safety issue: No ]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).
- Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination Score (Maintained Responder Population) [ Time Frame: Screening and Month 78 ] [ Designated as safety issue: No ]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).
- Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (ITT Population) [ Time Frame: Week 2, Month 12, Month 78 ] [ Designated as safety issue: No ]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.
- Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Responder Population) [ Time Frame: Week 2, Month 12, Month 78 ] [ Designated as safety issue: No ]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.
- Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Maintained Responder Population) [ Time Frame: Week 2, Month 12, Month 78 ] [ Designated as safety issue: No ]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.
| Enrollment: | 76 |
| Study Start Date: | May 2002 |
| Study Completion Date: | March 2009 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Active
Open label medication - Ropinirole CR
|
Drug: Ropinirole XL (formerly CR)
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.
Other Name: Ropinirole XL (formerly CR)
|
Eligibility| Ages Eligible for Study: | 30 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00650104
Locations
| United States, Arizona | |
| GSK Investigational Site | |
| Scottsdale, Arizona, United States, 85259 | |
| United States, California | |
| GSK Investigational Site | |
| Los Angeles, California, United States, 90033 | |
| GSK Investigational Site | |
| Oxnard, California, United States, 93030 | |
| United States, Florida | |
| GSK Investigational Site | |
| Miami, Florida, United States, 33136 | |
| GSK Investigational Site | |
| Tampa, Florida, United States, 33606 | |
| United States, Georgia | |
| GSK Investigational Site | |
| Augusta, Georgia, United States, 30912 | |
| United States, Kansas | |
| GSK Investigational Site | |
| Kansas City, Kansas, United States, 66160 | |
| United States, New Jersey | |
| GSK Investigational Site | |
| Edison, New Jersey, United States, 08818 | |
| United States, Pennsylvania | |
| GSK Investigational Site | |
| Upland, Pennsylvania, United States, 19013 | |
| United States, Texas | |
| GSK Investigational Site | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
No publications provided by GlaxoSmithKline
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00650104 History of Changes |
| Other Study ID Numbers: | 101468/196 |
| Study First Received: | March 27, 2008 |
| Results First Received: | February 24, 2010 |
| Last Updated: | May 2, 2013 |
| Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Norway: Norwegian Medicines Agency Netherlands: Medicines Evaluation Board (MEB) United States: Food and Drug Administration |
Keywords provided by GlaxoSmithKline:
|
ropinirole IR efficacy safety open-label |
long term safety; REQUIP ropinirole XL ropinirole CR Parkinson's disease |
Additional relevant MeSH terms:
|
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases Ropinirole Antiparkinson Agents |
Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Dopamine Agonists Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013