Trial Outcomes & Findings for A Fixed Dose Study of Ropinirole Prolonged Release as Adjunctive Treatment in Patients With Advanced Parkinson's Disease (NCT NCT01494532)
NCT ID: NCT01494532
Last Updated: 2018-06-20
Results Overview
"Off" time is defined as the state in which the participants(par) symptoms include lack of mobility(bradykinesia) with or without additional features such as tremor or rigidity. Par were asked to record awake time "off ", awake time "on", troublesome dyskinesias(TD) during awake time "on", or time asleep for 30 minute intervals in 24 hr diary cards for 2 days preceding visits. Total number of awake hrs spent "off" per 24-hr period was the average of the 2 diary cards of the sum of awake hours spent "off" in each 24-hr diary card. BL is the last non-missing assessment measured on or before the first dose, change from BL was calculated by subtracting the BL values from the MP Week 4 values. Mixed Model Repeated Measures (MMRM) model used BL total awake time 'Off', treatment, visit and treatment by visit
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
352 participants
Primary outcome timeframe
Baseline and Week 4 of the Maintenance Period (Study Week 17)
Results posted on
2018-06-20
Participant Flow
Eligible participants(par) were diagnosed with advanced stage idiopathic Parkinson's Disease (PD), demonstrated lack of control with Levo(L)-dopa therapy, and on a stable dose of L-dopa for a minimum of 4 weeks prior to screening. Par were randomized into one of six treatment arms to receive placebo or ropinirole prolonged release(PR) tablets.
After screening, par underwent a 13 Week up-titration period until reaching their target dose then continued on their target dose during a 4 Week Maintenance Period up to Week 17. All par underwent a 1 Week down-titration period and then a follow-up visit 2 Weeks after receiving the last dose of study medication.
Participant milestones
| Measure |
Treatment Group A: Placebo
Participants (par.) were administered a matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group B: 4 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group C: 8 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group D: 12 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group E: 16 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group F: 24 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
75
|
25
|
76
|
75
|
76
|
25
|
|
Overall Study
COMPLETED
|
65
|
21
|
59
|
60
|
64
|
25
|
|
Overall Study
NOT COMPLETED
|
10
|
4
|
17
|
15
|
12
|
0
|
Reasons for withdrawal
| Measure |
Treatment Group A: Placebo
Participants (par.) were administered a matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group B: 4 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group C: 8 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group D: 12 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group E: 16 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group F: 24 mg/Day
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
4
|
1
|
8
|
6
|
5
|
0
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
0
|
0
|
2
|
0
|
|
Overall Study
Protocol deviation
|
2
|
1
|
3
|
2
|
3
|
0
|
|
Overall Study
Protocol-defined stopping criteria
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
2
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
1
|
2
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
4
|
3
|
2
|
0
|
Baseline Characteristics
A Fixed Dose Study of Ropinirole Prolonged Release as Adjunctive Treatment in Patients With Advanced Parkinson's Disease
Baseline characteristics by cohort
| Measure |
Treatment Group A: Placebo
n=75 Participants
Participants (par.) were administered a matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group B: 4 mg/Day
n=25 Participants
Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group C: 8 mg/Day
n=76 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group D: 12 mg/Day
n=75 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group E: 16 mg/Day
n=76 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group F: 24 mg/Day
n=25 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Total
n=352 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
63.7 Years
STANDARD_DEVIATION 9.98 • n=5 Participants
|
66.5 Years
STANDARD_DEVIATION 7.45 • n=7 Participants
|
65.6 Years
STANDARD_DEVIATION 9.19 • n=5 Participants
|
65.2 Years
STANDARD_DEVIATION 9.62 • n=4 Participants
|
63.7 Years
STANDARD_DEVIATION 9.13 • n=21 Participants
|
66.9 Years
STANDARD_DEVIATION 7.94 • n=10 Participants
|
64.8 Years
STANDARD_DEVIATION 9.26 • n=115 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
38 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
168 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
38 Participants
n=21 Participants
|
15 Participants
n=10 Participants
|
184 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Asian - East Asian Heritage
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
20 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Asian - Japanese Heritage
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Asian - South East Asian Heritage
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
White - White/Caucasian/European Heritage
|
70 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
68 Participants
n=4 Participants
|
69 Participants
n=21 Participants
|
24 Participants
n=10 Participants
|
325 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 4 of the Maintenance Period (Study Week 17)Population: The Intent to Treat(ITT) Population included all randomized par who received at least one dose of study medication, had a BL efficacy assessment for the outcome, and at least one respective Post-BL efficacy assessment. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.
"Off" time is defined as the state in which the participants(par) symptoms include lack of mobility(bradykinesia) with or without additional features such as tremor or rigidity. Par were asked to record awake time "off ", awake time "on", troublesome dyskinesias(TD) during awake time "on", or time asleep for 30 minute intervals in 24 hr diary cards for 2 days preceding visits. Total number of awake hrs spent "off" per 24-hr period was the average of the 2 diary cards of the sum of awake hours spent "off" in each 24-hr diary card. BL is the last non-missing assessment measured on or before the first dose, change from BL was calculated by subtracting the BL values from the MP Week 4 values. Mixed Model Repeated Measures (MMRM) model used BL total awake time 'Off', treatment, visit and treatment by visit
Outcome measures
| Measure |
Treatment Group A: Placebo
n=65 Participants
Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group B: 4 mg/Day
n=21 Participants
Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group C: 8 mg/Day
n=60 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group D: 12 mg/Day
n=61 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group E: 16 mg/Day
n=65 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group F: 24 mg/Day
n=25 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
|---|---|---|---|---|---|---|
|
Change From Baseline (BL) in Total Awake Time Spent "Off" at Week 4 of Maintenance Period
|
-1.91 Hours
Interval -2.46 to -1.35
|
-2.04 Hours
Interval -3.02 to -1.06
|
-2.92 Hours
Interval -3.5 to -2.34
|
-2.34 Hours
Interval -2.91 to -1.76
|
-2.80 Hours
Interval -3.36 to -2.24
|
-2.37 Hours
Interval -3.26 to -1.47
|
SECONDARY outcome
Timeframe: Week 4 of the Maintenance Period (Study Week 17)Population: ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.
The responder rate was defined as the percentage of par with greater than or equal to (\>=) 20 percent (%) reduction in their individual BL "off" time at Week 4 of the Maintenance Period. The "off" time is defined as the state in which the participants' symptoms include lack of mobility (bradykinesia) with or without additional features such as tremor or rigidity. BL is defined as the last non-missing assessment measured on or before the first dose date. Responder Rate (Least Squares \[LS\] means on inverse linked scale), odds ratio with 95% CI and p-value comparing against placebo were estimated by Generalized Estimating Equations (GEE) model. Baseline total awake time 'Off', treatment, visit and treatment\*visit are included in the model.
Outcome measures
| Measure |
Treatment Group A: Placebo
n=65 Participants
Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group B: 4 mg/Day
n=21 Participants
Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group C: 8 mg/Day
n=60 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group D: 12 mg/Day
n=61 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group E: 16 mg/Day
n=65 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group F: 24 mg/Day
n=25 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
|---|---|---|---|---|---|---|
|
Responder Rate Defined as the Percentage of Participants With a 20% Reduction in Baseline (BL) "Off" Time at Week-4 of Maintenance Period
|
65.4 percentage of participants
Interval 52.4 to 76.4
|
68.0 percentage of participants
Interval 46.6 to 83.8
|
75.4 percentage of participants
Interval 63.0 to 84.6
|
64.3 percentage of participants
Interval 50.8 to 75.8
|
77.9 percentage of participants
Interval 66.0 to 86.5
|
72.0 percentage of participants
Interval 51.1 to 86.4
|
SECONDARY outcome
Timeframe: Baseline and Week 4 of the Maintenance Period (Study Week 17)Population: ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.
The "off" time is defined as the state in which the participants' symptoms include lack of mobility (bradykinesia) with or without additional features such as tremor or rigidity. BL is defined as the last non-missing assessment measured on or before the first dose date. The percent change from BL was calculated by subtracting the BL values from the Maintenance Period Week 4 values. Percentage of participants meeting the criterion (LS mean on inverse linked scale), odds ratio with 95% CI and p-value comparing against placebo were estimated by Generalized Estimating Equations (GEE) model. Baseline 'off-time', treatment, visit and treatment\*visit are included in the model.
Outcome measures
| Measure |
Treatment Group A: Placebo
n=65 Participants
Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group B: 4 mg/Day
n=21 Participants
Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group C: 8 mg/Day
n=60 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group D: 12 mg/Day
n=61 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group E: 16 mg/Day
n=65 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group F: 24 mg/Day
n=25 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With a >=1 Hour Reduction in Baseline "Off" Time at Week 4 of the Maintenance Period
|
72.1 percentage of participants
Interval 59.5 to 82.0
|
70.1 percentage of participants
Interval 48.6 to 85.4
|
80.6 percentage of participants
Interval 68.7 to 88.7
|
73.5 percentage of participants
Interval 59.6 to 83.9
|
83.2 percentage of participants
Interval 72.1 to 90.5
|
81.4 percentage of participants
Interval 62.3 to 92.0
|
SECONDARY outcome
Timeframe: Baseline and Week 4 of the Maintenance Period (Study Week 17)Population: ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.
The "off" time is defined as the state in which the participants' symptoms include lack of mobility (bradykinesia) with or without additional features such as tremor or rigidity. BL is defined as the last non-missing assessment measured on or before the first dose date. The percent change from BL was calculated by subtracting the BL values from the Maintenance Period Week 4 values. Percentage of participants meeting the criterion (LS mean on inverse linked scale), odds ratio with 95% CI and p-value comparing against placebo were estimated by Generalized Estimating Equations (GEE) model. Baseline 'off-time', treatment, visit and treatment\*visit are included in the model.
Outcome measures
| Measure |
Treatment Group A: Placebo
n=65 Participants
Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group B: 4 mg/Day
n=21 Participants
Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group C: 8 mg/Day
n=60 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group D: 12 mg/Day
n=61 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group E: 16 mg/Day
n=65 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group F: 24 mg/Day
n=25 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With a >=2 Hours Reduction in Baseline "Off" Time at Week 4 of the Maintenance Period
|
53.7 percentage of participants
Interval 39.8 to 67.1
|
45.6 percentage of participants
Interval 26.8 to 65.8
|
68.2 percentage of participants
Interval 54.8 to 79.2
|
53.6 percentage of participants
Interval 39.3 to 67.3
|
63.2 percentage of participants
Interval 49.6 to 75.0
|
51.3 percentage of participants
Interval 30.1 to 72.0
|
SECONDARY outcome
Timeframe: Week 4 of the Maintenance Period (Study Week 17)Population: ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.
The CGI-I scale allows the investigator to rate the participant's total improvement since the beginning of treatment (Baseline). Baseline is defined as the last non-missing assessment measured on or before the first dose date. The scale is rated from 1-7 where 1 = "very much improved", 2 = "much improved", 3 = "minimally improved", 4 = "no change", 5 = "minimally worse, 6 = "much worse", and 7 = "very much worse". The responder rate is defined as the percentage of participants with a score of 1 or 2. The Generalized Estimating Equations (GEE) model was used to determine CGI responder rate with treatment, visit, and treatment by visit interaction included in the model. Only scheduled visits were included.
Outcome measures
| Measure |
Treatment Group A: Placebo
n=65 Participants
Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group B: 4 mg/Day
n=21 Participants
Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group C: 8 mg/Day
n=60 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group D: 12 mg/Day
n=61 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group E: 16 mg/Day
n=65 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group F: 24 mg/Day
n=25 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
|---|---|---|---|---|---|---|
|
Responder Rate According to the Clinical Global Impression-global Improvement (CGI-I) Scale at Week 4 of the Maintenance Period
|
35 Percentage of participants
|
28 Percentage of participants
|
39 Percentage of participants
|
42 Percentage of participants
|
46 Percentage of participants
|
56 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 4 of the Maintenance Period (Study Week 17)Population: ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.
Dyskinesias are involuntary twisting, turning movements caused by medication during "on" time in Parkinson's Disease (PD). TD is defined as those movements that interfere with function and cause meaningful discomfort. Par were asked to record awake time "off", awake time "on", TD during awake time "on", or time asleep for all 30 minute time intervals in 24 hour diary cards for the 2 days preceding each visit. The total number of awake hours spent "on" without TD per 24-hour period was the average across the 2 diary cards of the sum of awake hours spent "on" without TD in each 24 hour diary card. The change from BL was calculated by subtracting the BL values from the MP Week 4 values. LS means, 95% CIs and P-values were estimated from Mixed Model Repeated Measures (MMRM). Par with a non-missing efficacy observation at BL and during the MP were analyzed.
Outcome measures
| Measure |
Treatment Group A: Placebo
n=65 Participants
Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group B: 4 mg/Day
n=21 Participants
Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group C: 8 mg/Day
n=60 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group D: 12 mg/Day
n=61 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group E: 16 mg/Day
n=65 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group F: 24 mg/Day
n=25 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Absolute Awake Time Spent "on" Without Troublesome Dyskinesia (TD) at Week 4 of the Maintenance Period
|
1.76 Hours
Interval 1.15 to 2.36
|
1.21 Hours
Interval 0.15 to 2.27
|
2.69 Hours
Interval 2.06 to 3.31
|
2.16 Hours
Interval 1.54 to 2.78
|
2.49 Hours
Interval 1.89 to 3.1
|
2.24 Hours
Interval 1.27 to 3.21
|
SECONDARY outcome
Timeframe: Baseline and Week 4 of the Maintenance Period (Study Week 17)Population: ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.
Par were asked to record awake time "off", awake time "on", TD during awake time "on", or time asleep for all 30 minute time intervals in 24 hour diary cards for the 2 days preceding each visit of the study. The total number of awake hours spent "on" per 24-hour period was the average across the 2 diary cards of the sum of the awake hours spent "on" in each 24 hour diary card. BL is defined as the last non-missing assessment measured on or before the first dose date. The change from BL was calculated by subtracting the BL values from the Maintenance Period Week 4 values. LS means, 95% CIs and P-values were estimated from MMRM.
Outcome measures
| Measure |
Treatment Group A: Placebo
n=65 Participants
Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group B: 4 mg/Day
n=21 Participants
Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group C: 8 mg/Day
n=60 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group D: 12 mg/Day
n=61 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group E: 16 mg/Day
n=65 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group F: 24 mg/Day
n=25 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Absolute Awake Time Spent "on" at Week 4 of the Maintenance Period
|
1.70 Hours
Interval 1.1 to 2.3
|
1.20 Hours
Interval 0.14 to 2.25
|
2.69 Hours
Interval 2.06 to 3.31
|
2.23 Hours
Interval 1.61 to 2.85
|
2.62 Hours
Interval 2.02 to 3.23
|
2.34 Hours
Interval 1.38 to 3.31
|
SECONDARY outcome
Timeframe: Baseline and Week 4 of the Maintenance Period (Study Week 17)Population: ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.
Par. were asked to record awake time "off", awake time "on", TD during awake time "on", or time asleep for all 30 minute time intervals in 24 hour diary cards for the 2 days preceding each visit of the study. The total sleep hours during the night time hours of sleep was the average across the 2 diary cards of the sum of time (hours) asleep during night time in each 24-hour diary card. BL is defined as the last non-missing assessment measured on or before the first dose date. The change from BL was calculated by subtracting the BL values from the Maintenance Period Week 4 values. LS means, 95% CIs and P-values were estimated from MMRM.
Outcome measures
| Measure |
Treatment Group A: Placebo
n=65 Participants
Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group B: 4 mg/Day
n=21 Participants
Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group C: 8 mg/Day
n=60 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group D: 12 mg/Day
n=61 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group E: 16 mg/Day
n=65 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group F: 24 mg/Day
n=25 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
|---|---|---|---|---|---|---|
|
Change From Baseline for Total Sleep Time During the Night Time Hours of Sleep at Week 4 of the Maintenance Period
|
0.22 Hours
Interval -0.13 to 0.56
|
0.86 Hours
Interval 0.25 to 1.46
|
0.22 Hours
Interval -0.14 to 0.58
|
0.15 Hours
Interval -0.21 to 0.51
|
0.14 Hours
Interval -0.21 to 0.49
|
0.04 Hours
Interval -0.51 to 0.6
|
SECONDARY outcome
Timeframe: Baseline and Week 4 of the Maintenance Period (Study Week 17)Population: ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.
The "off" state is defined as the state in which the participants' symptoms include lack of mobility (bradykinesia), with or without additional features such as tremor or rigidity. Par. were asked to record awake time "off", awake time "on", TD during awake time "on", or time asleep for all 30 minute time intervals in 24 hour diary cards for the 2 days preceding each visit of the study. The total number of awake hours spent "off" per 24-hour period was the average across the 2 diary cards of the sum of awake hours spent "off" in each 24-hour diary card. The percent change from BL was calculated by subtracting the BL values from the Maintenance Period Week 4 values divided by BL values multiplied (×) the results with 100. LS means, 95% CIs and P-values were estimated from MMRM.
Outcome measures
| Measure |
Treatment Group A: Placebo
n=65 Participants
Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group B: 4 mg/Day
n=21 Participants
Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group C: 8 mg/Day
n=60 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group D: 12 mg/Day
n=61 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group E: 16 mg/Day
n=65 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group F: 24 mg/Day
n=25 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Awake Time Spent "Off" at Week 4 of the Maintenance Period
|
-30.44 Percentage of "off" time in hours
Interval -39.67 to -21.21
|
-30.47 Percentage of "off" time in hours
Interval -46.69 to -14.24
|
-46.65 Percentage of "off" time in hours
Interval -56.27 to -37.03
|
-37.26 Percentage of "off" time in hours
Interval -46.81 to -27.71
|
-48.36 Percentage of "off" time in hours
Interval -57.64 to -39.08
|
-34.37 Percentage of "off" time in hours
Interval -49.23 to -19.5
|
SECONDARY outcome
Timeframe: Baseline and Week 4 of the Maintenance Period (Study Week 17)Population: ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.
Dyskinesias are involuntary twisting, turning movements caused by medication during "on" time in PD. TD is defined as those movements that interfere with function and cause meaningful discomfort. Par. were asked to record awake time "off", awake time "on", TD during awake time "on", or time asleep for all 30 minute time intervals in 24 hour diary cards for the 2 days preceding each visit of the study. The total number of awake hours spent "on" without TD per 24-hour period was the average across the 2 diary cards of the sum of awake hours spent "on" without TD in each 24-hour diary card. The percent change from BL was calculated by subtracting the BL values from the Maintenance Period Week 4 values divided by BL values × 100. LS means, 95% CIs and P-values were estimated from MMRM.
Outcome measures
| Measure |
Treatment Group A: Placebo
n=65 Participants
Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group B: 4 mg/Day
n=21 Participants
Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group C: 8 mg/Day
n=60 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group D: 12 mg/Day
n=61 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group E: 16 mg/Day
n=65 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group F: 24 mg/Day
n=25 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Awake Time Spent "on" Without TD at Week 4 of the Maintenance Period
|
24.55 Percentage of "on" time in hours
Interval 15.05 to 34.04
|
15.20 Percentage of "on" time in hours
Interval -1.37 to 31.78
|
35.20 Percentage of "on" time in hours
Interval 25.38 to 45.02
|
32.02 Percentage of "on" time in hours
Interval 22.2 to 41.84
|
34.45 Percentage of "on" time in hours
Interval 24.94 to 43.97
|
29.58 Percentage of "on" time in hours
Interval 14.39 to 44.76
|
SECONDARY outcome
Timeframe: Baseline and Week 4 of the Maintenance Period (Study Week 17)Population: ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.
Par. were asked to recordawake time "off", awake time "on", TD during awake time "on", or time asleep for all 30 minute time intervals in 24 hour diary cards for the 2 days preceding each visit of the study. The total number of awake hours spent "on" per 24-hour period was the average across the 2 diary cards of the sum of awake hours spent "on" in each 24-hour diary card. The percent change from BL was calculated by subtracting the BL values from the Maintenance Period Week 4 values divided by BL values × 100. LS means, 95% CIs and P-values were estimated from MMRM.
Outcome measures
| Measure |
Treatment Group A: Placebo
n=65 Participants
Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group B: 4 mg/Day
n=21 Participants
Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group C: 8 mg/Day
n=60 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group D: 12 mg/Day
n=61 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group E: 16 mg/Day
n=65 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group F: 24 mg/Day
n=25 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Awake Time Spent "on" at Week 4 of the Maintenance Period
|
21.31 Percentage of "on" time in hours
Interval 12.53 to 30.09
|
15.05 Percentage of "on" time in hours
Interval -0.28 to 30.38
|
35.68 Percentage of "on" time in hours
Interval 26.6 to 44.77
|
31.28 Percentage of "on" time in hours
Interval 22.19 to 40.36
|
32.34 Percentage of "on" time in hours
Interval 23.6 to 41.08
|
32.43 Percentage of "on" time in hours
Interval 18.39 to 46.48
|
SECONDARY outcome
Timeframe: Baseline and Week 4 of the Maintenance Period (Study Week 17)Population: ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.
Par. were asked to record awake time "off", awake time "on", TD during awake time "on", or time asleep for all 30 minute time intervals in 24 hour diary cards for the 2 days preceding each visit of the study. The total sleep hours during the night time hours of sleep was the average across the 2 diary cards of the sum of time (hours) asleep during night time in each 24-hour diary card. BL is defined as the last non-missing assessment measured on or before the first dose date. The percent change from BL was calculated by subtracting the BL values from the Maintenance Period Week 4 values divided by BL value × 100. LS means, 95% CIs and P-values were estimated from MMRM.
Outcome measures
| Measure |
Treatment Group A: Placebo
n=65 Participants
Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group B: 4 mg/Day
n=21 Participants
Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group C: 8 mg/Day
n=60 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group D: 12 mg/Day
n=61 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group E: 16 mg/Day
n=65 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group F: 24 mg/Day
n=25 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Total Sleep Time During the Night Time Hours of Sleep, at Week 4 of the Maintenance Period
|
3.99 Percentage of total sleep time in hours
Interval -0.42 to 8.39
|
10.79 Percentage of total sleep time in hours
Interval 3.04 to 18.54
|
4.94 Percentage of total sleep time in hours
Interval 0.34 to 9.54
|
3.41 Percentage of total sleep time in hours
Interval -1.15 to 7.98
|
3.60 Percentage of total sleep time in hours
Interval -0.83 to 8.03
|
0.91 Percentage of total sleep time in hours
Interval -6.19 to 8.01
|
SECONDARY outcome
Timeframe: Baseline and Week 4 of the Maintenance Period (Study Week 17)Population: ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.
The "off" state is defined as the state in which the participants' symptoms include lack of mobility(bradykinesia), with or without additional features such as tremor or rigidity. Par were asked to record awake time "off", awake time "on", TD during awake time "on", or time asleep for all 30 minute time intervals in 24 hour diary cards for the 2 days preceding each visit of the study. The total number of awake hours spent "off" per 24-hour period was the average across the 2 diary cards of the sum of awake hours spent "off" in each 24-hour diary card. The percentage of awake time spent "off"= Awake time spent "off" divided by (Awake time spent "off" + Awake time spent "on") × 100. BL is defined as the last non-missing assessment measured on or before the first dose date. The change from BL was calculated by subtracting the BL values from the MP Week 4 values. LS means, 95% CIs and P-values were estimated from MMRM.
Outcome measures
| Measure |
Treatment Group A: Placebo
n=65 Participants
Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group B: 4 mg/Day
n=21 Participants
Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group C: 8 mg/Day
n=60 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group D: 12 mg/Day
n=61 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group E: 16 mg/Day
n=65 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group F: 24 mg/Day
n=25 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in the Percent Awake Time Spent "Off" at Week 4 of the Maintenance Period
|
-12.43 Percentage of "off" time in hours
Interval -16.03 to -8.84
|
-11.60 Percentage of "off" time in hours
Interval -17.93 to -5.27
|
-18.41 Percentage of "off" time in hours
Interval -22.16 to -14.66
|
-15.36 Percentage of "off" time in hours
Interval -19.08 to -11.64
|
-17.81 Percentage of "off" time in hours
Interval -21.43 to -14.2
|
-15.01 Percentage of "off" time in hours
Interval -20.81 to -9.22
|
SECONDARY outcome
Timeframe: Baseline and Week 4 of the Maintenance Period (Study Week 17)Population: ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.
Dyskinesias are involuntary twisting, turning movements caused by medication during "on" time in PD. TD is defined as those movements that interfere with function and cause meaningful discomfort. Par were asked to record awake time "off", awake time "on", TD during awake time "on", or time asleep for all 30 minute time intervals in 24 hr diary cards for the 2 days preceding each visit of the study. The total number of awake hr spent "on" without TD per 24-hr period was the average across the 2 diary cards of the sum of awake hr spent "on" without TD in each 24-hr diary card. Percentage of awake time spent "on"without TD= Awake time spent "on" without TD divided by(Awake time spent "on" + Awake time spent "off") × 100. BL is defined as the last non-missing assessment measured on or before the first dose date, change from BL was calculated by subtracting BL values from MP Week 4 values. LS means, 95% CIs and P-values were estimated from MMRM.
Outcome measures
| Measure |
Treatment Group A: Placebo
n=65 Participants
Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group B: 4 mg/Day
n=21 Participants
Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group C: 8 mg/Day
n=60 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group D: 12 mg/Day
n=61 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group E: 16 mg/Day
n=65 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group F: 24 mg/Day
n=25 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in the Percent Awake Time Spent "on" Without TD at Week 4 of the Maintenance Period
|
12.89 Percentage of "on" time in hours
Interval 9.15 to 16.62
|
11.58 Percentage of "on" time in hours
Interval 5.01 to 18.15
|
18.34 Percentage of "on" time in hours
Interval 14.44 to 22.24
|
14.99 Percentage of "on" time in hours
Interval 11.12 to 18.85
|
17.05 Percentage of "on" time in hours
Interval 13.3 to 20.8
|
14.56 Percentage of "on" time in hours
Interval 8.54 to 20.59
|
SECONDARY outcome
Timeframe: Baseline and Week 4 of the Maintenance Period (Study Week 17)Population: ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.
Par. were asked to record awake time "off", awake time "on", TD during awake time "on", or time asleep for all 30 minute time intervals in 24 hour diary cards for the 2 days preceding each visit of the study. The total number of awake hours spent "on" per 24-hour period was the average across the 2 diary cards of the sum of awake hours spent "on" in each 24-hour diary card. The percentage of awake time spent "on"= Awake time spent "on" divided by (Awake time spent "on" + Awake time spent "off") × 100. BL is defined as the last non-missing assessment measured on or before the first dose date. The change from BL was calculated by subtracting the BL values from the Maintenance Period Week 4 values. LS means, 95% CIs and P-values were estimated from MMRM.
Outcome measures
| Measure |
Treatment Group A: Placebo
n=65 Participants
Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group B: 4 mg/Day
n=21 Participants
Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group C: 8 mg/Day
n=60 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group D: 12 mg/Day
n=61 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group E: 16 mg/Day
n=65 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group F: 24 mg/Day
n=25 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in the Percent Awake Time Spent "on" at Week 4 of the Maintenance Period
|
12.43 Percentage of "on" time in hours
Interval 8.84 to 16.03
|
11.60 Percentage of "on" time in hours
Interval 5.27 to 17.93
|
18.41 Percentage of "on" time in hours
Interval 14.66 to 22.16
|
15.36 Percentage of "on" time in hours
Interval 11.64 to 19.08
|
17.81 Percentage of "on" time in hours
Interval 14.2 to 21.43
|
15.01 Percentage of "on" time in hours
Interval 9.22 to 20.81
|
SECONDARY outcome
Timeframe: Baseline and Week 4 of the Maintenance Period (Study Week 17)Population: ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.
The "off" state is defined as the state in which the participants' symptoms include lack of mobility (bradykinesia), with or without additional features such as tremor or rigidity. Par were asked to record awake time "off", awake time "on", TD during awake time "on", or time asleep for all 30 minute time intervals in 24 hour diary cards for the 2 days preceding each visit of the study. The total number of day awake hours spent "off" per 24-hour period was the average across the 2 diary cards of the sum of awake hours spent "off" in each 24-hour diary card. The percentage of 24 hour day spent "off"= awake time spent "off" divided by 24 x 100. BL is defined as the last non-missing assessment measured on or before the first dose date. The change from BL was calculated by subtracting the BL values from the MP Week 4 values. LS means, 95% CIs and P-values were estimated from MMRM.
Outcome measures
| Measure |
Treatment Group A: Placebo
n=65 Participants
Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group B: 4 mg/Day
n=21 Participants
Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group C: 8 mg/Day
n=60 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group D: 12 mg/Day
n=61 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group E: 16 mg/Day
n=65 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group F: 24 mg/Day
n=25 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in the Percent of a 24-hour Day Spent "Off" at Week 4 of the Maintenance Period
|
-7.94 Percentage of "off" time in hours
Interval -10.26 to -5.62
|
-8.50 Percentage of "off" time in hours
Interval -12.57 to -4.43
|
-12.17 Percentage of "off" time in hours
Interval -14.59 to -9.76
|
-9.75 Percentage of "off" time in hours
Interval -12.14 to -7.35
|
-11.65 Percentage of "off" time in hours
Interval -13.98 to -9.32
|
-9.86 Percentage of "off" time in hours
Interval -13.59 to -6.13
|
SECONDARY outcome
Timeframe: Baseline and Week 4 of the Maintenance Period (Study Week 17)Population: ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.
Dyskinesias are involuntary twisting, turning movements caused by medication during "on" time in PD. TD is defined as those movements that interfere with function and cause meaningful discomfort. Par were asked to record awake time "off", awake time "on", TD during awake time "on", or time asleep for all 30 minute time intervals in 24 hr diary cards for the 2 days preceding each visit. The total number of day awake hr spent "on" without TD per 24-hr period was the average across the 2 diary cards of the sum of awake hours spent "on" without TD in each 24-hour diary card. The percentage of 24 hr day spent "on" without TD= awake time spent "on" without TD divided by 24 × 100. BL is defined as the last non-missing assessment measured on or before the first dose date, change from BL was calculated by subtracting the BL values from the MP Week 4 values. LS means, 95% CIs and P-values were estimated from MMRM.
Outcome measures
| Measure |
Treatment Group A: Placebo
n=65 Participants
Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group B: 4 mg/Day
n=21 Participants
Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group C: 8 mg/Day
n=60 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group D: 12 mg/Day
n=61 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group E: 16 mg/Day
n=65 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group F: 24 mg/Day
n=25 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in the Percent of a 24- Hour Day Spent "on" Without TD at Week 4 of the Maintenance Period
|
7.32 Percentage of "on" time in hours
Interval 4.81 to 9.83
|
5.03 Percentage of "on" time in hours
Interval 0.62 to 9.44
|
11.19 Percentage of "on" time in hours
Interval 8.57 to 13.81
|
8.99 Percentage of "on" time in hours
Interval 6.4 to 11.59
|
10.40 Percentage of "on" time in hours
Interval 7.88 to 12.91
|
9.34 Percentage of "on" time in hours
Interval 5.3 to 13.38
|
SECONDARY outcome
Timeframe: Baseline and Week 4 of the Maintenance Period (Study Week 17)Population: ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.
Par. were asked to record awake time "off", awake time "on", TD during awake time "on", or time asleep for all 30 minute time intervals in 24 hour diary cards for the 2 days preceding each visit of the study. The total number of day awake hours spent "on" per 24-hour period was the average across the 2 diary cards of the sum of awake hours spent "on" in each 24-hour diary card. The percentage of a 24-hour day spent "on" = Awake time spent "on" divided by 24 × 100. BL is defined as the last non-missing assessment measured on or before the first dose date. The change from BL was calculated by subtracting the BL values from the Maintenance Period Week 4 values. LS means, 95% CIs and P-values were estimated from MMRM.
Outcome measures
| Measure |
Treatment Group A: Placebo
n=65 Participants
Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group B: 4 mg/Day
n=21 Participants
Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group C: 8 mg/Day
n=60 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group D: 12 mg/Day
n=61 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group E: 16 mg/Day
n=65 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group F: 24 mg/Day
n=25 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in the Percent of a 24-hour Day Spent "on" at Week 4 of the Maintenance Period
|
7.08 Percentage of "on" time in hours
Interval 4.57 to 9.58
|
4.99 Percentage of "on" time in hours
Interval 0.59 to 9.39
|
11.20 Percentage of "on" time in hours
Interval 8.59 to 13.81
|
9.28 Percentage of "on" time in hours
Interval 6.69 to 11.87
|
10.94 Percentage of "on" time in hours
Interval 8.42 to 13.45
|
9.76 Percentage of "on" time in hours
Interval 5.73 to 13.8
|
SECONDARY outcome
Timeframe: Baseline and Week 4 of the Maintenance Period (Study Week 17)Population: ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.
Par were asked to record awake time "off", awake time "on", TD during awake time "on", or time asleep for all 30 minute time intervals in 24 hour diary cards for the 2 days preceding each visit of the study. The total sleep hours during the night time hours of sleep was the average across the 2 diary cards of the sum of time (hours) asleep during night time in each 24-hour diary card. The percentage of a 24-hour day spent asleep during the night time hours = Total sleep hours during the night time hours of sleep divided by 24 × 100. BL is defined as the last non-missing assessment measured on or before the first dose date. The change from BL was calculated by subtracting the BL values from the Maintenance Period Week 4 values. LS means, 95% CIs and P-values were estimated from MMRM.
Outcome measures
| Measure |
Treatment Group A: Placebo
n=65 Participants
Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group B: 4 mg/Day
n=21 Participants
Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group C: 8 mg/Day
n=60 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group D: 12 mg/Day
n=61 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group E: 16 mg/Day
n=65 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group F: 24 mg/Day
n=25 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Total Sleep Time During the Night Time Hours of Sleep as a Percentage of a 24-hour Day, at Week 4 of the Maintenance Period
|
0.91 Percentage of time in hours
Interval -0.53 to 2.35
|
3.57 Percentage of time in hours
Interval 1.04 to 6.1
|
0.92 Percentage of time in hours
Interval -0.59 to 2.42
|
0.63 Percentage of time in hours
Interval -0.86 to 2.12
|
0.58 Percentage of time in hours
Interval -0.87 to 2.02
|
0.18 Percentage of time in hours
Interval -2.14 to 2.5
|
SECONDARY outcome
Timeframe: Baseline and Week 4 of the Maintenance Period (Study Week 17)Population: ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.
The UPDRS is a clinician based rating scale used to measure motor impairments and disability. The UPDRS assesses six features of PD impairment. These are evaluated using a combination of data collected by interview and examination of the par.. One of the six features include the Part III-motor examination where scores can range 0 to 108 with par. in an "on" state where the maximum score indicates the worse condition. BL is defined as the last non-missing assessment measured on or before the first dose date. The change from BL was calculated by subtracting the BL values from the Maintenance Period Week 4 values. LS means, 95% CIs and P-values were estimated from MMRM.
Outcome measures
| Measure |
Treatment Group A: Placebo
n=64 Participants
Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group B: 4 mg/Day
n=21 Participants
Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group C: 8 mg/Day
n=59 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group D: 12 mg/Day
n=60 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group E: 16 mg/Day
n=65 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group F: 24 mg/Day
n=24 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Unified Parkinson Disease Rating Scale (UPDRS) Motor Score With Participants in an "on" State, at Week 4 of the Maintenance Period
|
-4.75 Score on scale
Interval -6.78 to -2.72
|
-10.38 Score on scale
Interval -13.94 to -6.82
|
-8.43 Score on scale
Interval -10.54 to -6.32
|
-8.34 Score on scale
Interval -10.43 to -6.24
|
-8.86 Score on scale
Interval -10.88 to -6.85
|
-10.06 Score on scale
Interval -13.37 to -6.75
|
SECONDARY outcome
Timeframe: Baseline and Week 4 of the Maintenance Period (Study Week 17)Population: ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.
The UPDRS Part II is the ADL score and can range from 0 to 52 as determined by the physician. The higher score indicates the worse condition. Test were performed when the par. is in the "on" state of PD. BL is defined as the last non-missing assessment measured on or before the first dose date. The change from BL was calculated by subtracting the BL values from the Maintenance Period Week 4 values. LS means, 95% CIs and P-values were estimated from MMRM.
Outcome measures
| Measure |
Treatment Group A: Placebo
n=65 Participants
Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group B: 4 mg/Day
n=20 Participants
Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group C: 8 mg/Day
n=60 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group D: 12 mg/Day
n=58 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group E: 16 mg/Day
n=63 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group F: 24 mg/Day
n=24 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in UPDRS Activities of Daily Living (ADL) Score With Participants in an "on" State, at Week 4 of the Maintenance Period
|
-1.32 Score on scale
Interval -2.17 to -0.47
|
-3.08 Score on scale
Interval -4.61 to -1.56
|
-3.06 Score on scale
Interval -3.94 to -2.18
|
-2.18 Score on scale
Interval -3.07 to -1.28
|
-2.63 Score on scale
Interval -3.49 to -1.77
|
-3.04 Score on scale
Interval -4.43 to -1.65
|
SECONDARY outcome
Timeframe: Baseline and Week 4 of the Maintenance Period (Study Week 17)Population: ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.
The UPDRS Part II is the ADL score and can range from 0 to 52 as determined by the physician. The higher score indicates the worse condition. Test was performed when the par is in the "off" state of PD. The "off" time is defined as the state in which the participants' symptoms include lack of mobility (bradykinesia) with or without additional features such as tremor or rigidity. BL is defined as the last non-missing assessment measured on or before the first dose date. The change from BL was calculated by subtracting the BL values from the Maintenance Period Week 4 values. LS means, 95% CIs and P-values were estimated from MMRM.
Outcome measures
| Measure |
Treatment Group A: Placebo
n=62 Participants
Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group B: 4 mg/Day
n=15 Participants
Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group C: 8 mg/Day
n=52 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group D: 12 mg/Day
n=50 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group E: 16 mg/Day
n=57 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group F: 24 mg/Day
n=22 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in UPDRS ADL Score With Participants in an "Off" State, at Week 4 of the Maintenance Period
|
-2.94 Score on scale
Interval -4.23 to -1.65
|
-4.50 Score on scale
Interval -7.12 to -1.88
|
-4.72 Score on scale
Interval -6.13 to -3.31
|
-4.29 Score on scale
Interval -5.74 to -2.84
|
-5.76 Score on scale
Interval -7.11 to -4.41
|
-4.77 Score on scale
Interval -6.94 to -2.61
|
SECONDARY outcome
Timeframe: Baseline (BL) and Week 4 of the Maintenance Period (Study Week 17)Population: ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.
The UPDRS Part I scores mentation, behavior and mood as determined by a physician and par. were tested during the "on" phase of PD. This component of the UPDRS is the total score for 4 items (the items 1 to 4 include intellectual impairment, thought disorder, motivation / initiative, and depression) and may have a value ranging from 0 to 16 as determined by a physician. The higher score (16) indicates the maximum score and the worse condition. All 4 items have to be present for a total score to be calculated. If one or more items are missing, the total score for the component would also be missing. BL is defined as the last non-missing assessment measured on or before the first dose date. The change from BL was calculated by subtracting the BL values from the individual post-randomization values. LS means, 95% CIs and P-values were estimated from MMRM.
Outcome measures
| Measure |
Treatment Group A: Placebo
n=65 Participants
Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group B: 4 mg/Day
n=21 Participants
Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group C: 8 mg/Day
n=60 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group D: 12 mg/Day
n=61 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group E: 16 mg/Day
n=65 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group F: 24 mg/Day
n=25 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in UPDRS Part I at Week 4 of the Maintenance Period
|
-0.24 Score on scale
Interval -0.47 to -0.01
|
-0.44 Score on scale
Interval -0.84 to -0.03
|
-0.33 Score on scale
Interval -0.57 to -0.09
|
-0.24 Score on scale
Interval -0.48 to 0.0
|
-0.47 Score on scale
Interval -0.7 to -0.24
|
-0.45 Score on scale
Interval -0.82 to -0.08
|
SECONDARY outcome
Timeframe: From start of study treatment until end of treatment (assessed up to 18 weeks)Population: ITT Population. Participants with a non-missing efficacy observation at Baseline and at least one post-Baseline efficacy assessment at any time during the study were analyzed.
The percentage of participants who withdrew from the study due to lack of efficacy as defined by either the participant or the investigator is presented here. All participants with a non-missing efficacy observation at Baseline and at least one post-Baseline efficacy assessment at any time during the study were analyzed.
Outcome measures
| Measure |
Treatment Group A: Placebo
n=74 Participants
Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group B: 4 mg/Day
n=25 Participants
Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group C: 8 mg/Day
n=76 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group D: 12 mg/Day
n=73 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group E: 16 mg/Day
n=76 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group F: 24 mg/Day
n=25 Participants
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Withdrawn From the Study Due to Lack of Efficacy
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
3 Percentage of participants
|
0 Percentage of participants
|
Adverse Events
Treatment Group A: Placebo
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
Treatment Group B: 4 mg/Day
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Treatment Group C: 8 mg/Day
Serious events: 3 serious events
Other events: 27 other events
Deaths: 0 deaths
Treatment Group D: 12 mg/Day
Serious events: 0 serious events
Other events: 40 other events
Deaths: 0 deaths
Treatment Group E: 16 mg/Day
Serious events: 1 serious events
Other events: 43 other events
Deaths: 0 deaths
Treatment Group F: 24 mg/Day
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment Group A: Placebo
n=75 participants at risk
Participants (par.) were administered a matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group B: 4 mg/Day
n=25 participants at risk
Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group C: 8 mg/Day
n=76 participants at risk
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group D: 12 mg/Day
n=75 participants at risk
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group E: 16 mg/Day
n=76 participants at risk
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group F: 24 mg/Day
n=25 participants at risk
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/75 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
0.00%
0/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
1.3%
1/76 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
0.00%
0/75 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
0.00%
0/76 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
0.00%
0/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
|
General disorders
Hernia
|
0.00%
0/75 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
0.00%
0/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
1.3%
1/76 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
0.00%
0/75 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
0.00%
0/76 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
0.00%
0/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
|
0.00%
0/75 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
0.00%
0/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
0.00%
0/76 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
0.00%
0/75 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
1.3%
1/76 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
0.00%
0/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
|
Psychiatric disorders
Impulsive behaviour
|
0.00%
0/75 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
0.00%
0/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
1.3%
1/76 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
0.00%
0/75 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
0.00%
0/76 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
0.00%
0/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
Other adverse events
| Measure |
Treatment Group A: Placebo
n=75 participants at risk
Participants (par.) were administered a matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group B: 4 mg/Day
n=25 participants at risk
Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group C: 8 mg/Day
n=76 participants at risk
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group D: 12 mg/Day
n=75 participants at risk
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group E: 16 mg/Day
n=76 participants at risk
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
Treatment Group F: 24 mg/Day
n=25 participants at risk
Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
5.3%
4/75 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
0.00%
0/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
0.00%
0/76 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
0.00%
0/75 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
0.00%
0/76 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
0.00%
0/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
10.7%
8/75 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
6.6%
5/76 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
10.7%
8/75 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
9.2%
7/76 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
8.0%
2/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
|
Infections and infestations
Nasopharyngitis
|
1.3%
1/75 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
0.00%
0/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
2.6%
2/76 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
2.7%
2/75 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
0.00%
0/76 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
8.0%
2/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Fall
|
5.3%
4/75 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
0.00%
0/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
1.3%
1/76 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
4.0%
3/75 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
2.6%
2/76 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
0.00%
0/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/75 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
0.00%
0/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
2.6%
2/76 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
0.00%
0/75 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
2.6%
2/76 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
8.0%
2/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
|
Nervous system disorders
Dizziness
|
2.7%
2/75 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
8.0%
2/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
3.9%
3/76 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
8.0%
6/75 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
5.3%
4/76 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
|
Nervous system disorders
Dyskinesia
|
1.3%
1/75 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
3.9%
3/76 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
6.7%
5/75 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
10.5%
8/76 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
|
Nervous system disorders
Headache
|
5.3%
4/75 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
0.00%
0/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
2.6%
2/76 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
4.0%
3/75 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
5.3%
4/76 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
|
Nervous system disorders
Somnolence
|
5.3%
4/75 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
4.0%
1/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
5.3%
4/76 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
12.0%
9/75 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
10.5%
8/76 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
0.00%
0/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
|
Nervous system disorders
Sudden onset of sleep
|
2.7%
2/75 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
8.0%
2/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
5.3%
4/76 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
4.0%
3/75 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
1.3%
1/76 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
0.00%
0/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/75 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
0.00%
0/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
0.00%
0/76 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
1.3%
1/75 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
5.3%
4/76 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
0.00%
0/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
|
Vascular disorders
Hypertension
|
1.3%
1/75 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
8.0%
2/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
1.3%
1/76 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
1.3%
1/75 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
3.9%
3/76 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
8.0%
2/25 • Serious adverse events (SAEs) and non-serious AEs were collected from the initial dose of study treatment through the completion of the Follow-up Period (up to 33 Weeks)
On-treatment SAEs and non-serious AEs were reported for the Safety Population, comprised all participants exposed to at least one dose of study medication.
|
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