Trial Outcomes & Findings for 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 (NCT NCT00650104)
NCT ID: NCT00650104
Last Updated: 2013-05-06
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
76 participants
Primary outcome timeframe
Screening; Week 4; Months 3, 9, 15, 21, 27, 33, 39, 45, 51, 57, 63, 69, 75, and 78
Results posted on
2013-05-06
Participant Flow
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.
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
|
83
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Overall Study
COMPLETED
|
42
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Overall Study
NOT COMPLETED
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41
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Reasons for withdrawal
| Measure |
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.
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|---|---|
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Overall Study
Adverse Event
|
17
|
|
Overall Study
Death
|
2
|
|
Overall Study
Withdrawal by Subject
|
11
|
|
Overall Study
Physician Decision
|
7
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Non-compliance
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2
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|
Overall Study
Sponsor Terminated Dosing
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1
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Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
Ropinirole XL
n=83 Participants
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.
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|---|---|
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Age Continuous
|
65.1 years
STANDARD_DEVIATION 9.85 • n=5 Participants
|
|
Sex: Female, Male
Female
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37 Participants
n=5 Participants
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|
Sex: Female, Male
Male
|
46 Participants
n=5 Participants
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|
Race/Ethnicity, Customized
Caucasian
|
74 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
6 participants
n=5 Participants
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|
Race/Ethnicity, Customized
Black
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1 participants
n=5 Participants
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|
Race/Ethnicity, Customized
Asian
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1 participants
n=5 Participants
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|
Race/Ethnicity, Customized
Other
|
1 participants
n=5 Participants
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|
Weight
|
79.24 kilograms (kg)
STANDARD_DEVIATION 16.8 • n=5 Participants
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PRIMARY outcome
Timeframe: Screening; Week 4; Months 3, 9, 15, 21, 27, 33, 39, 45, 51, 57, 63, 69, 75, and 78Population: 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.
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.
Outcome measures
| Measure |
Ropinirole XL
n=83 Participants
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.
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|---|---|
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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
|
|
Unified Parkinson's Disease (PD) Rating Scale (UPDRS) Total Activities of Daily Living Scores (Intent-to-Treat Population)
Up-titration (Week 4), n=64
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8.9 points on a scale
Standard Deviation 4.60
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|
Unified Parkinson's Disease (PD) Rating Scale (UPDRS) Total Activities of Daily Living Scores (Intent-to-Treat Population)
LTT, Month 3, n=76
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8.2 points on a scale
Standard Deviation 5.34
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|
Unified Parkinson's Disease (PD) Rating Scale (UPDRS) Total Activities of Daily Living Scores (Intent-to-Treat Population)
LTT, Month 9, n=72
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8.1 points on a scale
Standard Deviation 5.03
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|
Unified Parkinson's Disease (PD) Rating Scale (UPDRS) Total Activities of Daily Living Scores (Intent-to-Treat Population)
LTT, Month 15, n=67
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9.0 points on a scale
Standard Deviation 5.83
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|
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
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|
Unified Parkinson's Disease (PD) Rating Scale (UPDRS) Total Activities of Daily Living Scores (Intent-to-Treat Population)
LTT, Month 27, n=58
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9.3 points on a scale
Standard Deviation 5.59
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Unified Parkinson's Disease (PD) Rating Scale (UPDRS) Total Activities of Daily Living Scores (Intent-to-Treat Population)
LTT, Month 33, n=53
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10.3 points on a scale
Standard Deviation 6.14
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Unified Parkinson's Disease (PD) Rating Scale (UPDRS) Total Activities of Daily Living Scores (Intent-to-Treat Population)
LTT, Month 39, n=19
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10.5 points on a scale
Standard Deviation 6.74
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Unified Parkinson's Disease (PD) Rating Scale (UPDRS) Total Activities of Daily Living Scores (Intent-to-Treat Population)
LTT, Month 45, n=18
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9.3 points on a scale
Standard Deviation 4.47
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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
|
|
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 5.80
|
|
Unified Parkinson's Disease (PD) Rating Scale (UPDRS) Total Activities of Daily Living Scores (Intent-to-Treat Population)
LTT, Month 63, n=19
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11.9 points on a scale
Standard Deviation 7.23
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|
Unified Parkinson's Disease (PD) Rating Scale (UPDRS) Total Activities of Daily Living Scores (Intent-to-Treat Population)
LTT, Month 69, n=20
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10.8 points on a scale
Standard Deviation 6.70
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|
Unified Parkinson's Disease (PD) Rating Scale (UPDRS) Total Activities of Daily Living Scores (Intent-to-Treat Population)
LTT, Month 75, n=16
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12.6 points on a scale
Standard Deviation 6.66
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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
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PRIMARY outcome
Timeframe: 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".
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.
Outcome measures
| Measure |
Ropinirole XL
n=83 Participants
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.
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|---|---|
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Number of Participants With the Indicated Number of Adverse Events (AEs)
Par. with AEs not related to st. med.
|
6 participants
|
|
Number of Participants With the Indicated Number of Adverse Events (AEs)
Participants (Par.) with at least one event
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81 participants
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|
Number of Participants With the Indicated Number of Adverse Events (AEs)
Par. with 0 events
|
2 participants
|
|
Number of Participants With the Indicated Number of Adverse Events (AEs)
Par. with 1 event
|
1 participants
|
|
Number of Participants With the Indicated Number of Adverse Events (AEs)
Par. with 2 events
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0 participants
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|
Number of Participants With the Indicated Number of Adverse Events (AEs)
Par. with ≥3 events
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80 participants
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|
Number of Participants With the Indicated Number of Adverse Events (AEs)
Par. with mild AEs (by maximum intensity)
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3 participants
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|
Number of Participants With the Indicated Number of Adverse Events (AEs)
Par. with moderate AEs (by maximum intensity)
|
38 participants
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|
Number of Participants With the Indicated Number of Adverse Events (AEs)
Par. with severe AEs (by maximum intensity)
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40 participants
|
|
Number of Participants With the Indicated Number of Adverse Events (AEs)
Par. with AEs not likely related to st. med.
|
6 participants
|
|
Number of Participants With the Indicated Number of Adverse Events (AEs)
Par. with AEs suspected to be related to st. med.
|
36 participants
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|
Number of Participants With the Indicated Number of Adverse Events (AEs)
Par. with AEs probably related to st. med.
|
33 participants
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|
Number of Participants With the Indicated Number of Adverse Events (AEs)
Par. who withdrew study due to AEs
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20 participants
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Number of Participants With the Indicated Number of Adverse Events (AEs)
Par. reporting SAEs
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35 participants
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SECONDARY outcome
Timeframe: Screening; Months 3, 9, 15, 27, and 78Population: 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.
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.
Outcome measures
| Measure |
Ropinirole XL
n=60 Participants
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.
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|---|---|
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Unified Parkinson's Disease Rating Scale (UPDRS) Total Activities of Daily Living Score (Responder Population)
Screening, n=60
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9.1 points on a scale
Standard Deviation 5.08
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Unified Parkinson's Disease Rating Scale (UPDRS) Total Activities of Daily Living Score (Responder Population)
LTT, Month 3, n=59
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8.0 points on a scale
Standard Deviation 5.18
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Unified Parkinson's Disease Rating Scale (UPDRS) Total Activities of Daily Living Score (Responder Population)
LTT, Month 9, n=58
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7.8 points on a scale
Standard Deviation 4.92
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Unified Parkinson's Disease Rating Scale (UPDRS) Total Activities of Daily Living Score (Responder Population)
LTT, Month 15, n=55
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8.7 points on a scale
Standard Deviation 5.76
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Unified Parkinson's Disease Rating Scale (UPDRS) Total Activities of Daily Living Score (Responder Population)
LTT, Month 27, n=47
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8.8 points on a scale
Standard Deviation 5.80
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Unified Parkinson's Disease Rating Scale (UPDRS) Total Activities of Daily Living Score (Responder Population)
LTT, Month 78, n=13
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11.5 points on a scale
Standard Deviation 6.64
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SECONDARY outcome
Timeframe: Screening; Months 3, 9, 15, 27, and 78Population: 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.
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.
Outcome measures
| Measure |
Ropinirole XL
n=47 Participants
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.
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|---|---|
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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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
SECONDARY outcome
Timeframe: Screening and Month 78Population: Intent-to-Treat (ITT) Population. Various "n" values are the result of participant attrition.
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).
Outcome measures
| Measure |
Ropinirole XL
n=83 Participants
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.
|
|---|---|
|
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
|
|
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 outcome
Timeframe: Screening and Month 78Population: Responder Population. Various "n" values are the result of participant attrition.
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).
Outcome measures
| Measure |
Ropinirole XL
n=60 Participants
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.
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|---|---|
|
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
|
|
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 outcome
Timeframe: Screening and Month 78Population: Maintained Responder Population. Various "n" values are the result of participant attrition.
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).
Outcome measures
| Measure |
Ropinirole XL
n=47 Participants
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.
|
|---|---|
|
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
|
|
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 outcome
Timeframe: Week 2, Month 12, Month 78Population: Intent-to-Treat (ITT) Population. Various "n" values are the result of participant attrition.
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.
Outcome measures
| Measure |
Ropinirole XL
n=70 Participants
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.
|
|---|---|
|
Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (ITT Population)
Week 2 - Very Much Improved, n=70
|
0 participants
|
|
Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (ITT Population)
Week 2 - Much Improved, n=70
|
2 participants
|
|
Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (ITT Population)
Week 2 - Minimally Improved, n=70
|
20 participants
|
|
Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (ITT Population)
Week 2 - No Change, n=70
|
43 participants
|
|
Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (ITT Population)
Week 2 - Minimally Worse, n=70
|
4 participants
|
|
Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (ITT Population)
Week 2 - Much Worse, n=70
|
1 participants
|
|
Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (ITT Population)
Week 2 - Very Much Worse, n=70
|
0 participants
|
|
Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (ITT Population)
Month 12 - Very Much Improved, n=69
|
7 participants
|
|
Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (ITT Population)
Month 12 - Much Improved, n=69
|
25 participants
|
|
Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (ITT Population)
Month 12 - Minimally Improved, n=69
|
20 participants
|
|
Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (ITT Population)
Month 12 - No Change, n=69
|
7 participants
|
|
Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (ITT Population)
Month 12 - Minimally Worse, n=69
|
8 participants
|
|
Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (ITT Population)
Month 12 - Much Worse, n=69
|
1 participants
|
|
Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (ITT Population)
Month 12 - Very Much Worse, n=69
|
0 participants
|
|
Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (ITT Population)
Month 78 -Very Much Improved, n=13
|
1 participants
|
|
Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (ITT Population)
Month 78 - Much Improved, n=13
|
8 participants
|
|
Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (ITT Population)
Month 78 - Minimally Improved, n=13
|
1 participants
|
|
Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (ITT Population)
Month 78 - No Change, n=13
|
1 participants
|
|
Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (ITT Population)
Month 78 - Minimally Worse, n=13
|
1 participants
|
|
Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (ITT Population)
Month 78 - Much Worse, n=13
|
0 participants
|
|
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 outcome
Timeframe: Week 2, Month 12, Month 78Population: Responder Population. Various "n" values are the result of participant attrition.
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.
Outcome measures
| Measure |
Ropinirole XL
n=56 Participants
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.
|
|---|---|
|
Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Responder Population)
Week 2 - Very Much Improved, n=49
|
0 participants
|
|
Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Responder Population)
Week 2 - Much Improved, n=49
|
2 participants
|
|
Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Responder Population)
Week 2 - Minimally Improved, n=49
|
17 participants
|
|
Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Responder Population)
Week 2 - No Change, n=49
|
27 participants
|
|
Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Responder Population)
Week 2 - Minimally Worse, n=49
|
2 participants
|
|
Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Responder Population)
Week 2 - Much Worse, n=49
|
1 participants
|
|
Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Responder Population)
Week 2 - Very Much Worse, n=49
|
0 participants
|
|
Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Responder Population)
Month 12 - Very Much Improved, n=56
|
7 participants
|
|
Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Responder Population)
Month 12 - Much Improved, n=56
|
25 participants
|
|
Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Responder Population)
Month 12 - Minimally Improved, n=56
|
12 participants
|
|
Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Responder Population)
Month 12 - No Change, n=56
|
5 participants
|
|
Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Responder Population)
Month 12 - Minimally Worse, n=56
|
5 participants
|
|
Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Responder Population)
Month 12 - Much Worse, n=56
|
1 participants
|
|
Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Responder Population)
Month 12 - Very Much Worse, n=56
|
0 participants
|
|
Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Responder Population)
Month 78 - Very Much Improved, n=13
|
1 participants
|
|
Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Responder Population)
Month 78 - Much Improved, n=13
|
8 participants
|
|
Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Responder Population)
Month 78 - Minimally Improved, n=13
|
1 participants
|
|
Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Responder Population)
Month 78 - No Change, n=13
|
1 participants
|
|
Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Responder Population)
Month 78 - Minimally Worse, n=13
|
1 participants
|
|
Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Responder Population)
Month 78 - Much Worse, n=13
|
0 participants
|
|
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 outcome
Timeframe: Week 2, Month 12, Month 78Population: Maintained Responder Population. Various "n" values are the result of participant attrition.
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.
Outcome measures
| Measure |
Ropinirole XL
n=46 Participants
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.
|
|---|---|
|
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
|
|
Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Maintained Responder Population)
Week 2 - Much Improved, n=37
|
2 participants
|
|
Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Maintained Responder Population)
Week 2 - Minimally Improved, n=37
|
12 participants
|
|
Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Maintained Responder Population)
Week 2 - No Change, n=37
|
20 participants
|
|
Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Maintained Responder Population)
Week 2 - Minimally Worse, n=37
|
2 participants
|
|
Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Maintained Responder Population)
Week 2 - Much Worse, n=37
|
1 participants
|
|
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
|
|
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
|
|
Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Maintained Responder Population)
Month 12 - Much Improved, n=46
|
23 participants
|
|
Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Maintained Responder Population)
Month 12 - Minimally Improved, n=46
|
7 participants
|
|
Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Maintained Responder Population)
Month 12 - No Change, n=46
|
4 participants
|
|
Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Maintained Responder Population)
Month 12 - Minimally Worse, n=46
|
4 participants
|
|
Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Maintained Responder Population)
Month 12 - Much Worse, n=46
|
1 participants
|
|
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
|
|
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
|
|
Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Maintained Responder Population)
Month 78 - Much Improved, n=13
|
8 participants
|
|
Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Maintained Responder Population)
Month 78 - Minimally Improved, n=13
|
1 participants
|
|
Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Maintained Responder Population)
Month 78 - No Change, n=13
|
1 participants
|
|
Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Maintained Responder Population)
Month 78 - Minimally Worse, n=13
|
1 participants
|
|
Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Maintained Responder Population)
Month 78 - Much Worse, n=13
|
0 participants
|
|
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
|
Adverse Events
Ropinirole XL
Serious events: 34 serious events
Other events: 83 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ropinirole XL
n=83 participants at risk
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.
|
|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
6.0%
5/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
General disorders
Chest pain
|
4.8%
4/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
4.8%
4/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
General disorders
Non-cardiac chest pain
|
2.4%
2/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Cardiac disorders
Angina pectoris
|
2.4%
2/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Cardiac disorders
Coronary heart disease
|
2.4%
2/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Injury, poisoning and procedural complications
Overdose
|
2.4%
2/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protusion
|
2.4%
2/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Musculoskeletal and connective tissue disorders
Muscle strain
|
2.4%
2/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
2.4%
2/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Musculoskeletal and connective tissue disorders
Femoral neck fracture
|
2.4%
2/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Renal and urinary disorders
Renal failure
|
2.4%
2/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Gastrointestinal disorders
Ileus
|
1.2%
1/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Nervous system disorders
Cerebrovascular accident
|
1.2%
1/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
1.2%
1/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
1.2%
1/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Psychiatric disorders
Delirium
|
1.2%
1/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
1.2%
1/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
1.2%
1/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Infections and infestations
Appendiceal abcess
|
1.2%
1/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Nervous system disorders
Encephalopathy
|
1.2%
1/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Infections and infestations
Postoperative wound infection
|
1.2%
1/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Infections and infestations
Influenza
|
1.2%
1/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
1.2%
1/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
1.2%
1/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Gastrointestinal disorders
Gastritis
|
1.2%
1/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Infections and infestations
Bronchitis
|
1.2%
1/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Cardiac disorders
Atrial flutter
|
1.2%
1/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Cardiac disorders
Sick sinus syndrome
|
1.2%
1/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Reproductive system and breast disorders
Pelvic pain
|
1.2%
1/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Gastrointestinal disorders
Proctalgia
|
1.2%
1/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial irritiation
|
1.2%
1/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Infections and infestations
Tracheobronchitis
|
1.2%
1/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Hepatobiliary disorders
Biliary colic
|
1.2%
1/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.2%
1/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
1.2%
1/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Musculoskeletal and connective tissue disorders
Spondylisthesis
|
1.2%
1/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Gastrointestinal disorders
Postoerative ileus
|
1.2%
1/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Gastrointestinal disorders
Inguinal hernia
|
1.2%
1/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
1.2%
1/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Psychiatric disorders
Delusion
|
1.2%
1/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Psychiatric disorders
Paranoia
|
1.2%
1/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
1.2%
1/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Musculoskeletal and connective tissue disorders
Invertebral disc degeneration
|
1.2%
1/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Nervous system disorders
Multiple sclerosis
|
1.2%
1/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Infections and infestations
Urinary tract infection
|
1.2%
1/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Psychiatric disorders
Obsessive-complusive disorder
|
1.2%
1/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Psychiatric disorders
Mania
|
1.2%
1/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Cardiac disorders
Coronary artery stenosis
|
1.2%
1/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
1.2%
1/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
General disorders
Oedema peripheral
|
1.2%
1/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Nervous system disorders
Syncope
|
1.2%
1/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Infections and infestations
Urosepsis
|
1.2%
1/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Injury, poisoning and procedural complications
Accident
|
1.2%
1/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Blood and lymphatic system disorders
Aortic aneurysm rupture
|
1.2%
1/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
General disorders
Malaise
|
1.2%
1/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Nervous system disorders
Metabolic encephalopathy
|
1.2%
1/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
Other adverse events
| Measure |
Ropinirole XL
n=83 participants at risk
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.
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
42.2%
35/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Nervous system disorders
Dizziness
|
41.0%
34/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
General disorders
Oedema peripheral
|
38.6%
32/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.7%
28/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Nervous system disorders
Headache
|
31.3%
26/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Infections and infestations
Nasopharyngitis
|
28.9%
24/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
27.7%
23/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Nervous system disorders
Somnolence
|
27.7%
23/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Psychiatric disorders
Insomnia
|
26.5%
22/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Gastrointestinal disorders
Constipation
|
25.3%
21/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.3%
21/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
General disorders
Fatigue
|
24.1%
20/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Gastrointestinal disorders
Diarrhoea
|
24.1%
20/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
22.9%
19/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Psychiatric disorders
Depression
|
21.7%
18/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Infections and infestations
Upper respiratory tract infection
|
18.1%
15/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Gastrointestinal disorders
Vomiting
|
18.1%
15/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Psychiatric disorders
Hallucination
|
16.9%
14/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Injury, poisoning and procedural complications
Fall
|
15.7%
13/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
15.7%
13/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
15.7%
13/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Infections and infestations
Bronchitis
|
14.5%
12/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Nervous system disorders
Hypoaesthesia
|
14.5%
12/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Nervous system disorders
Tremor
|
14.5%
12/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Gastrointestinal disorders
Abdominal pain
|
14.5%
12/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Gastrointestinal disorders
Dyspepsia
|
14.5%
12/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Psychiatric disorders
Anxiety
|
14.5%
12/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Psychiatric disorders
Confusional state
|
13.3%
11/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Infections and infestations
Urinary tract infection
|
13.3%
11/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
12.0%
10/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Eye disorders
Vision blurred
|
12.0%
10/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Gastrointestinal disorders
Gastrointestinal reflux disease
|
12.0%
10/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Infections and infestations
Tooth infection
|
10.8%
9/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
General disorders
Asthenia
|
10.8%
9/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Blood and lymphatic system disorders
Hypertension
|
10.8%
9/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Nervous system disorders
Balance disorder
|
7.2%
6/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Nervous system disorders
Cognitive disorder
|
6.0%
5/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Nervous system disorders
Paraesthesia
|
6.0%
5/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Nervous system disorders
Parkinson's disease
|
6.0%
5/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Nervous system disorders
Sinus headache
|
6.0%
5/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Gastrointestinal disorders
Dry mouth
|
8.4%
7/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Gastrointestinal disorders
Abdominal distension
|
6.0%
5/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.0%
5/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
9.6%
8/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
9.6%
8/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
8.4%
7/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
8.4%
7/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
6.0%
5/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.0%
5/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Gastrointestinal disorders
Flatulence
|
6.0%
5/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Infections and infestations
Influenza
|
8.4%
7/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Infections and infestations
Herpes zoster
|
6.0%
5/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
General disorders
Chest pain
|
8.4%
7/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
General disorders
Pain
|
7.2%
6/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Psychiatric disorders
Nightmare
|
7.2%
6/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.0%
5/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
6.0%
5/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.4%
7/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
6.0%
5/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Eye disorders
Cataract
|
6.0%
5/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Investigations
Weight decreased
|
6.0%
5/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Blood and lymphatic system disorders
Orthostatic hypotension
|
8.4%
7/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Cardiac disorders
Angina pectoris
|
6.0%
5/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
6.0%
5/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
|
Blood and lymphatic system disorders
Anaemia
|
6.0%
5/83 • On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER