Parkinson Disease
Conditions
Keywords
ropinirole IR, efficacy, safety, open-label, long term safety; REQUIP, ropinirole XL, ropinirole CR, Parkinson's disease
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.
Interventions
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.
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Unified Parkinson's Disease (PD) Rating Scale (UPDRS) Total Activities of Daily Living Scores (Intent-to-Treat Population) | 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) | 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
| Measure | Time frame | Description |
|---|---|---|
| Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination Score (ITT Population) | 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). |
| Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination Score (Reponder Population) | 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). |
| Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination Score (Maintained Responder Population) | 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). |
| Unified Parkinson's Disease Rating Scale (UPDRS) Total Activities of Daily Living Score (Responder Population) | 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. |
| Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Responder Population) | Week 2, Month 12, Month 78 | 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) | Week 2, Month 12, Month 78 | 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) (ITT Population) | Week 2, Month 12, Month 78 | 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. |
| Unified Parkinson's Disease Rating Scale (UPDRS) Total Activities of Daily Living Scores (Maintained Responder Population) | 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. |
Countries
United States
Participant flow
Pre-assignment details
Study 101468/196 (this study; NCT#00650104) was an open-label, ropinirole XL (2-24 mg/day), continuation study for participants with Parkinson's Disease who previously completed Studies 167 or 164. Treatment was originally designed to continue for 3 years, but it was extended until ropinirole XL became commercially available in each study country.
Participants by arm
| Arm | Count |
|---|---|
| Ropinirole XL Up-titration: some participants from Study 167 started at 2 milligrams (mg) ropinirole XL once daily. Then, depending on the response/tolerance of each participant, the dose was increased in 1 mg weekly increments to 4 mg, then 2 mg weekly increments up to 12 mg, and in either 2 mg or 4 mg weekly increments up to 24 mg to the clinical optimum dose. Other Study 167 participants were increased in 2 mg weekly increments up to 8 mg and then 4 mg weekly increments up to 24 mg. Study 164 particiapnts who were on an optimal dose of ropinirole XL could go straight into the long-term treatment period, and those who were receiving ropinirole IR could be switched to the corresponding XL dose. Long-term treatment: participants received study medication until market availability of ropinirole XL. After market availability, participants would undergo a 1-week down-titration period; after protocol amendment #4 approval, participants could switch directly to the market-available dose. | 83 |
| Total | 83 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 17 |
| Overall Study | Death | 2 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Non-compliance | 2 |
| Overall Study | Physician Decision | 7 |
| Overall Study | Sponsor Terminated Dosing | 1 |
| Overall Study | Withdrawal by Subject | 11 |
Baseline characteristics
| Characteristic | Ropinirole XL |
|---|---|
| Age Continuous | 65.1 years STANDARD_DEVIATION 9.85 |
| Race/Ethnicity, Customized Asian | 1 participants |
| Race/Ethnicity, Customized Black | 1 participants |
| Race/Ethnicity, Customized Caucasian | 74 participants |
| Race/Ethnicity, Customized Hispanic | 6 participants |
| Race/Ethnicity, Customized Other | 1 participants |
| Sex: Female, Male Female | 37 Participants |
| Sex: Female, Male Male | 46 Participants |
| Weight | 79.24 kilograms (kg) STANDARD_DEVIATION 16.8 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 83 / 83 |
| serious Total, serious adverse events | 34 / 83 |
Outcome results
Primary
Number of Participants With the Indicated Number of Adverse Events (AEs)
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.
Time frame: Every study visit from baseline to market availability (Month 78)
Population: All participants who received at least one dose of study medication. The treatment-emergent Study 196 AEs were defined as occurring during initial titration or long-term treatment or follow up.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ropinirole XL | Number of Participants With the Indicated Number of Adverse Events (AEs) | Participants (Par.) with at least one event | 81 participants |
| Ropinirole XL | Number of Participants With the Indicated Number of Adverse Events (AEs) | Par. with 0 events | 2 participants |
| Ropinirole XL | Number of Participants With the Indicated Number of Adverse Events (AEs) | Par. with 1 event | 1 participants |
| Ropinirole XL | Number of Participants With the Indicated Number of Adverse Events (AEs) | Par. with 2 events | 0 participants |
| Ropinirole XL | Number of Participants With the Indicated Number of Adverse Events (AEs) | Par. with ≥3 events | 80 participants |
| Ropinirole XL | Number of Participants With the Indicated Number of Adverse Events (AEs) | Par. with mild AEs (by maximum intensity) | 3 participants |
| Ropinirole XL | Number of Participants With the Indicated Number of Adverse Events (AEs) | Par. with moderate AEs (by maximum intensity) | 38 participants |
| Ropinirole XL | Number of Participants With the Indicated Number of Adverse Events (AEs) | Par. with severe AEs (by maximum intensity) | 40 participants |
| Ropinirole XL | Number of Participants With the Indicated Number of Adverse Events (AEs) | Par. with AEs not related to st. med. | 6 participants |
| Ropinirole XL | Number of Participants With the Indicated Number of Adverse Events (AEs) | Par. with AEs not likely related to st. med. | 6 participants |
| Ropinirole XL | Number of Participants With the Indicated Number of Adverse Events (AEs) | Par. with AEs suspected to be related to st. med. | 36 participants |
| Ropinirole XL | Number of Participants With the Indicated Number of Adverse Events (AEs) | Par. with AEs probably related to st. med. | 33 participants |
| Ropinirole XL | Number of Participants With the Indicated Number of Adverse Events (AEs) | Par. who withdrew study due to AEs | 20 participants |
| Ropinirole XL | Number of Participants With the Indicated Number of Adverse Events (AEs) | Par. reporting SAEs | 35 participants |
Primary
Unified Parkinson's Disease (PD) Rating Scale (UPDRS) Total Activities of Daily Living Scores (Intent-to-Treat Population)
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.
Time frame: Screening; Week 4; Months 3, 9, 15, 21, 27, 33, 39, 45, 51, 57, 63, 69, 75, and 78
Population: Intent-to-Treat (ITT) Population: all participants who received at least one dose of study medication and who had at least one treatment period evaluation for any parameter were included in the evaluation of the therapeutic benefit. Various n values are the result of participant attrition.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ropinirole XL | Unified Parkinson's Disease (PD) Rating Scale (UPDRS) Total Activities of Daily Living Scores (Intent-to-Treat Population) | Screening, n=83 | 9.4 points on a scale | Standard Deviation 5.14 |
| Ropinirole XL | Unified Parkinson's Disease (PD) Rating Scale (UPDRS) Total Activities of Daily Living Scores (Intent-to-Treat Population) | Up-titration (Week 4), n=64 | 8.9 points on a scale | Standard Deviation 4.6 |
| Ropinirole XL | Unified Parkinson's Disease (PD) Rating Scale (UPDRS) Total Activities of Daily Living Scores (Intent-to-Treat Population) | LTT, Month 3, n=76 | 8.2 points on a scale | Standard Deviation 5.34 |
| Ropinirole XL | Unified Parkinson's Disease (PD) Rating Scale (UPDRS) Total Activities of Daily Living Scores (Intent-to-Treat Population) | LTT, Month 9, n=72 | 8.1 points on a scale | Standard Deviation 5.03 |
| Ropinirole XL | Unified Parkinson's Disease (PD) Rating Scale (UPDRS) Total Activities of Daily Living Scores (Intent-to-Treat Population) | LTT, Month 15, n=67 | 9.0 points on a scale | Standard Deviation 5.83 |
| Ropinirole XL | Unified Parkinson's Disease (PD) Rating Scale (UPDRS) Total Activities of Daily Living Scores (Intent-to-Treat Population) | LTT, Month 21, n=63 | 8.6 points on a scale | Standard Deviation 5.01 |
| Ropinirole XL | Unified Parkinson's Disease (PD) Rating Scale (UPDRS) Total Activities of Daily Living Scores (Intent-to-Treat Population) | LTT, Month 27, n=58 | 9.3 points on a scale | Standard Deviation 5.59 |
| Ropinirole XL | Unified Parkinson's Disease (PD) Rating Scale (UPDRS) Total Activities of Daily Living Scores (Intent-to-Treat Population) | LTT, Month 33, n=53 | 10.3 points on a scale | Standard Deviation 6.14 |
| Ropinirole XL | Unified Parkinson's Disease (PD) Rating Scale (UPDRS) Total Activities of Daily Living Scores (Intent-to-Treat Population) | LTT, Month 39, n=19 | 10.5 points on a scale | Standard Deviation 6.74 |
| Ropinirole XL | Unified Parkinson's Disease (PD) Rating Scale (UPDRS) Total Activities of Daily Living Scores (Intent-to-Treat Population) | LTT, Month 45, n=18 | 9.3 points on a scale | Standard Deviation 4.47 |
| Ropinirole XL | Unified Parkinson's Disease (PD) Rating Scale (UPDRS) Total Activities of Daily Living Scores (Intent-to-Treat Population) | LTT, Month 51, n=19 | 10.1 points on a scale | Standard Deviation 6.07 |
| Ropinirole XL | Unified Parkinson's Disease (PD) Rating Scale (UPDRS) Total Activities of Daily Living Scores (Intent-to-Treat Population) | LTT, Month 57, n=20 | 10.4 points on a scale | Standard Deviation 5.8 |
| Ropinirole XL | Unified Parkinson's Disease (PD) Rating Scale (UPDRS) Total Activities of Daily Living Scores (Intent-to-Treat Population) | LTT, Month 63, n=19 | 11.9 points on a scale | Standard Deviation 7.23 |
| Ropinirole XL | Unified Parkinson's Disease (PD) Rating Scale (UPDRS) Total Activities of Daily Living Scores (Intent-to-Treat Population) | LTT, Month 69, n=20 | 10.8 points on a scale | Standard Deviation 6.7 |
| Ropinirole XL | Unified Parkinson's Disease (PD) Rating Scale (UPDRS) Total Activities of Daily Living Scores (Intent-to-Treat Population) | LTT, Month 75, n=16 | 12.6 points on a scale | Standard Deviation 6.66 |
| Ropinirole XL | Unified Parkinson's Disease (PD) Rating Scale (UPDRS) Total Activities of Daily Living Scores (Intent-to-Treat Population) | LTT, Month 78, n=13 | 11.5 points on a scale | Standard Deviation 6.64 |
Secondary
Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (ITT Population)
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.
Time frame: Week 2, Month 12, Month 78
Population: Intent-to-Treat (ITT) Population. Various n values are the result of participant attrition.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ropinirole XL | Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (ITT Population) | Week 2 - Very Much Improved, n=70 | 0 participants |
| Ropinirole XL | Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (ITT Population) | Week 2 - Much Improved, n=70 | 2 participants |
| Ropinirole XL | Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (ITT Population) | Week 2 - Minimally Improved, n=70 | 20 participants |
| Ropinirole XL | Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (ITT Population) | Week 2 - No Change, n=70 | 43 participants |
| Ropinirole XL | Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (ITT Population) | Week 2 - Minimally Worse, n=70 | 4 participants |
| Ropinirole XL | Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (ITT Population) | Week 2 - Much Worse, n=70 | 1 participants |
| Ropinirole XL | Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (ITT Population) | Week 2 - Very Much Worse, n=70 | 0 participants |
| Ropinirole XL | Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (ITT Population) | Month 12 - Very Much Improved, n=69 | 7 participants |
| Ropinirole XL | Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (ITT Population) | Month 12 - Much Improved, n=69 | 25 participants |
| Ropinirole XL | Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (ITT Population) | Month 12 - Minimally Improved, n=69 | 20 participants |
| Ropinirole XL | Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (ITT Population) | Month 12 - No Change, n=69 | 7 participants |
| Ropinirole XL | Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (ITT Population) | Month 12 - Minimally Worse, n=69 | 8 participants |
| Ropinirole XL | Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (ITT Population) | Month 12 - Much Worse, n=69 | 1 participants |
| Ropinirole XL | Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (ITT Population) | Month 12 - Very Much Worse, n=69 | 0 participants |
| Ropinirole XL | Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (ITT Population) | Month 78 -Very Much Improved, n=13 | 1 participants |
| Ropinirole XL | Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (ITT Population) | Month 78 - Much Improved, n=13 | 8 participants |
| Ropinirole XL | Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (ITT Population) | Month 78 - Minimally Improved, n=13 | 1 participants |
| Ropinirole XL | Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (ITT Population) | Month 78 - No Change, n=13 | 1 participants |
| Ropinirole XL | Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (ITT Population) | Month 78 - Minimally Worse, n=13 | 1 participants |
| Ropinirole XL | Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (ITT Population) | Month 78 - Much Worse, n=13 | 0 participants |
| Ropinirole XL | Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (ITT Population) | Month 78 - Very Much Worse, n=13 | 0 participants |
Secondary
Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Maintained Responder Population)
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.
Time frame: Week 2, Month 12, Month 78
Population: Maintained Responder Population. Various n values are the result of participant attrition.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ropinirole XL | Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Maintained Responder Population) | Week 2 - Very Much Improved, n=37 | 0 participants |
| Ropinirole XL | Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Maintained Responder Population) | Week 2 - Much Improved, n=37 | 2 participants |
| Ropinirole XL | Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Maintained Responder Population) | Week 2 - Minimally Improved, n=37 | 12 participants |
| Ropinirole XL | Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Maintained Responder Population) | Week 2 - No Change, n=37 | 20 participants |
| Ropinirole XL | Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Maintained Responder Population) | Week 2 - Minimally Worse, n=37 | 2 participants |
| Ropinirole XL | Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Maintained Responder Population) | Week 2 - Much Worse, n=37 | 1 participants |
| Ropinirole XL | Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Maintained Responder Population) | Week 2 - Very Much Worse, n=37 | 0 participants |
| Ropinirole XL | Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Maintained Responder Population) | Month 12 - Very Much Improved, n=46 | 6 participants |
| Ropinirole XL | Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Maintained Responder Population) | Month 12 - Much Improved, n=46 | 23 participants |
| Ropinirole XL | Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Maintained Responder Population) | Month 12 - Minimally Improved, n=46 | 7 participants |
| Ropinirole XL | Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Maintained Responder Population) | Month 12 - No Change, n=46 | 4 participants |
| Ropinirole XL | Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Maintained Responder Population) | Month 12 - Minimally Worse, n=46 | 4 participants |
| Ropinirole XL | Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Maintained Responder Population) | Month 12 - Much Worse, n=46 | 1 participants |
| Ropinirole XL | Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Maintained Responder Population) | Month 12 - Very Much Worse, n=46 | 0 participants |
| Ropinirole XL | Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Maintained Responder Population) | Month 78 - Very Much Improved, n=13 | 1 participants |
| Ropinirole XL | Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Maintained Responder Population) | Month 78 - Much Improved, n=13 | 8 participants |
| Ropinirole XL | Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Maintained Responder Population) | Month 78 - Minimally Improved, n=13 | 1 participants |
| Ropinirole XL | Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Maintained Responder Population) | Month 78 - No Change, n=13 | 1 participants |
| Ropinirole XL | Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Maintained Responder Population) | Month 78 - Minimally Worse, n=13 | 1 participants |
| Ropinirole XL | Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Maintained Responder Population) | Month 78 - Much Worse, n=13 | 0 participants |
| Ropinirole XL | Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Maintained Responder Population) | Month 78 - Very Much Worse, n=13 | 0 participants |
Secondary
Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Responder Population)
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.
Time frame: Week 2, Month 12, Month 78
Population: Responder Population. Various n values are the result of participant attrition.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ropinirole XL | Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Responder Population) | Week 2 - Very Much Improved, n=49 | 0 participants |
| Ropinirole XL | Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Responder Population) | Week 2 - Much Improved, n=49 | 2 participants |
| Ropinirole XL | Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Responder Population) | Week 2 - Minimally Improved, n=49 | 17 participants |
| Ropinirole XL | Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Responder Population) | Week 2 - No Change, n=49 | 27 participants |
| Ropinirole XL | Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Responder Population) | Week 2 - Minimally Worse, n=49 | 2 participants |
| Ropinirole XL | Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Responder Population) | Week 2 - Much Worse, n=49 | 1 participants |
| Ropinirole XL | Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Responder Population) | Week 2 - Very Much Worse, n=49 | 0 participants |
| Ropinirole XL | Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Responder Population) | Month 12 - Very Much Improved, n=56 | 7 participants |
| Ropinirole XL | Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Responder Population) | Month 12 - Much Improved, n=56 | 25 participants |
| Ropinirole XL | Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Responder Population) | Month 12 - Minimally Improved, n=56 | 12 participants |
| Ropinirole XL | Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Responder Population) | Month 12 - No Change, n=56 | 5 participants |
| Ropinirole XL | Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Responder Population) | Month 12 - Minimally Worse, n=56 | 5 participants |
| Ropinirole XL | Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Responder Population) | Month 12 - Much Worse, n=56 | 1 participants |
| Ropinirole XL | Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Responder Population) | Month 12 - Very Much Worse, n=56 | 0 participants |
| Ropinirole XL | Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Responder Population) | Month 78 - Very Much Improved, n=13 | 1 participants |
| Ropinirole XL | Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Responder Population) | Month 78 - Much Improved, n=13 | 8 participants |
| Ropinirole XL | Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Responder Population) | Month 78 - Minimally Improved, n=13 | 1 participants |
| Ropinirole XL | Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Responder Population) | Month 78 - No Change, n=13 | 1 participants |
| Ropinirole XL | Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Responder Population) | Month 78 - Minimally Worse, n=13 | 1 participants |
| Ropinirole XL | Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Responder Population) | Month 78 - Much Worse, n=13 | 0 participants |
| Ropinirole XL | Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Responder Population) | Month 78 - Very Much Worse, n=13 | 0 participants |
Secondary
Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination Score (ITT Population)
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).
Time frame: Screening and Month 78
Population: Intent-to-Treat (ITT) Population. Various n values are the result of participant attrition.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ropinirole XL | Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination Score (ITT Population) | Screening, n=83 | 22.0 points on a scale | Standard Deviation 10.14 |
| Ropinirole XL | Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination Score (ITT Population) | Month 78, n=13 | 20.7 points on a scale | Standard Deviation 7.09 |
Secondary
Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination Score (Maintained Responder Population)
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).
Time frame: Screening and Month 78
Population: Maintained Responder Population. Various n values are the result of participant attrition.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ropinirole XL | Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination Score (Maintained Responder Population) | Screening, n=47 | 22.2 points on a scale | Standard Deviation 10.11 |
| Ropinirole XL | Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination Score (Maintained Responder Population) | Month 78, n=13 | 20.7 points on a scale | Standard Deviation 7.09 |
Secondary
Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination Score (Reponder Population)
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).
Time frame: Screening and Month 78
Population: Responder Population. Various n values are the result of participant attrition.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ropinirole XL | Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination Score (Reponder Population) | Screening, n=60 | 21.7 points on a scale | Standard Deviation 9.71 |
| Ropinirole XL | Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination Score (Reponder Population) | Month 78, n=13 | 20.7 points on a scale | Standard Deviation 7.09 |
Secondary
Unified Parkinson's Disease Rating Scale (UPDRS) Total Activities of Daily Living Score (Responder Population)
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.
Time frame: Screening; Months 3, 9, 15, 27, and 78
Population: Responder: a subset of the ITT Population containing those participants who had a score of 1 (very much improved) or 2 (much improved) on the clinical global impression (CGI) scale during the study. CGI-I scores (1 to 7 \[very much worse\]) the participant's condition relative to baseline. Various n values are the result of participant attrition.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ropinirole XL | Unified Parkinson's Disease Rating Scale (UPDRS) Total Activities of Daily Living Score (Responder Population) | Screening, n=60 | 9.1 points on a scale | Standard Deviation 5.08 |
| Ropinirole XL | Unified Parkinson's Disease Rating Scale (UPDRS) Total Activities of Daily Living Score (Responder Population) | LTT, Month 3, n=59 | 8.0 points on a scale | Standard Deviation 5.18 |
| Ropinirole XL | Unified Parkinson's Disease Rating Scale (UPDRS) Total Activities of Daily Living Score (Responder Population) | LTT, Month 9, n=58 | 7.8 points on a scale | Standard Deviation 4.92 |
| Ropinirole XL | Unified Parkinson's Disease Rating Scale (UPDRS) Total Activities of Daily Living Score (Responder Population) | LTT, Month 15, n=55 | 8.7 points on a scale | Standard Deviation 5.76 |
| Ropinirole XL | Unified Parkinson's Disease Rating Scale (UPDRS) Total Activities of Daily Living Score (Responder Population) | LTT, Month 27, n=47 | 8.8 points on a scale | Standard Deviation 5.8 |
| Ropinirole XL | Unified Parkinson's Disease Rating Scale (UPDRS) Total Activities of Daily Living Score (Responder Population) | LTT, Month 78, n=13 | 11.5 points on a scale | Standard Deviation 6.64 |
Secondary
Unified Parkinson's Disease Rating Scale (UPDRS) Total Activities of Daily Living Scores (Maintained Responder Population)
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.
Time frame: Screening; Months 3, 9, 15, 27, and 78
Population: Maintained Responder : subset of the Responder Population, which was maintained or further decreased for a minimum of 4 weeks whilst the participant received a stable or decreasing dose of study medication. Various n values are the result of participant attrition.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ropinirole XL | Unified Parkinson's Disease Rating Scale (UPDRS) Total Activities of Daily Living Scores (Maintained Responder Population) | Screening, n=47 | 9.0 points on a scale | Standard Deviation 5.33 |
| Ropinirole XL | Unified Parkinson's Disease Rating Scale (UPDRS) Total Activities of Daily Living Scores (Maintained Responder Population) | LTT, Month 3, n=46 | 7.7 points on a scale | Standard Deviation 5.53 |
| Ropinirole XL | Unified Parkinson's Disease Rating Scale (UPDRS) Total Activities of Daily Living Scores (Maintained Responder Population) | LTT, Month 9, n= 46 | 7.7 points on a scale | Standard Deviation 5.09 |
| Ropinirole XL | Unified Parkinson's Disease Rating Scale (UPDRS) Total Activities of Daily Living Scores (Maintained Responder Population) | LTT, Month 15, n=44 | 8.6 points on a scale | Standard Deviation 5.97 |
| Ropinirole XL | Unified Parkinson's Disease Rating Scale (UPDRS) Total Activities of Daily Living Scores (Maintained Responder Population) | LTT, Month 27, n=37 | 8.4 points on a scale | Standard Deviation 5.68 |
| Ropinirole XL | Unified Parkinson's Disease Rating Scale (UPDRS) Total Activities of Daily Living Scores (Maintained Responder Population) | LTT, Month 78, n=13 | 11.5 points on a scale | Standard Deviation 6.64 |