Trial Outcomes & Findings for Ophthalmologic Safety Study of Pramipexole Immediate Release (IR) Versus Ropinirole in Early Parkinson's Disease (PD) Patients (NCT NCT00144300)
NCT ID: NCT00144300
Last Updated: 2014-03-14
Results Overview
Expert panel of ophthalmologists assessed retinal deterioration by a review of the components of the comprehensive ophthalmology assessments
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
246 participants
Primary outcome timeframe
up to 2 years
Results posted on
2014-03-14
Participant Flow
Participant milestones
| Measure |
Pramipexole
Flexible: 0.125 mg 3 times daily up to maximum tolerated
|
Ropinirole
Flexible: 0.25 mg 3 times daily up to maximum tolerated
|
|---|---|---|
|
Overall Study
STARTED
|
121
|
125
|
|
Overall Study
COMPLETED
|
92
|
97
|
|
Overall Study
NOT COMPLETED
|
29
|
28
|
Reasons for withdrawal
| Measure |
Pramipexole
Flexible: 0.125 mg 3 times daily up to maximum tolerated
|
Ropinirole
Flexible: 0.25 mg 3 times daily up to maximum tolerated
|
|---|---|---|
|
Overall Study
Adverse Event
|
18
|
16
|
|
Overall Study
Protocol Violation
|
1
|
3
|
|
Overall Study
Lost to Follow-up
|
3
|
0
|
|
Overall Study
Withdrawal by Subject
|
6
|
6
|
|
Overall Study
Other reason (not specified)
|
1
|
3
|
Baseline Characteristics
Ophthalmologic Safety Study of Pramipexole Immediate Release (IR) Versus Ropinirole in Early Parkinson's Disease (PD) Patients
Baseline characteristics by cohort
| Measure |
Pramipexole
n=121 Participants
Flexible: 0.125 mg 3 times daily up to maximum tolerated
|
Ropinirole
n=125 Participants
Flexible: 0.25 mg 3 times daily up to maximum tolerated
|
Total
n=246 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.5 years
STANDARD_DEVIATION 9.3 • n=93 Participants
|
59.1 years
STANDARD_DEVIATION 8.7 • n=4 Participants
|
58.3 years
STANDARD_DEVIATION 9.0 • n=27 Participants
|
|
Age, Customized
< 50 years
|
23 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
40 Participants
n=27 Participants
|
|
Age, Customized
50 to < 65 years
|
71 Participants
n=93 Participants
|
74 Participants
n=4 Participants
|
145 Participants
n=27 Participants
|
|
Age, Customized
65 to < 75 years
|
21 Participants
n=93 Participants
|
30 Participants
n=4 Participants
|
51 Participants
n=27 Participants
|
|
Age, Customized
>= 75 years
|
6 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=93 Participants
|
47 Participants
n=4 Participants
|
89 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
79 Participants
n=93 Participants
|
78 Participants
n=4 Participants
|
157 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black
|
7 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White
|
113 Participants
n=93 Participants
|
121 Participants
n=4 Participants
|
234 Participants
n=27 Participants
|
|
Height
|
171.3 centimeters
STANDARD_DEVIATION 9.2 • n=93 Participants
|
171.6 centimeters
STANDARD_DEVIATION 12.4 • n=4 Participants
|
171.5 centimeters
STANDARD_DEVIATION 10.9 • n=27 Participants
|
|
Weight
|
81.32 kilograms
STANDARD_DEVIATION 17.64 • n=93 Participants
|
82.80 kilograms
STANDARD_DEVIATION 18.39 • n=4 Participants
|
82.07 kilograms
STANDARD_DEVIATION 18.00 • n=27 Participants
|
|
Duration of Parkinson's disease diagnosis
|
0.97 years
STANDARD_DEVIATION 1.15 • n=93 Participants
|
1.29 years
STANDARD_DEVIATION 1.70 • n=4 Participants
|
1.13 years
STANDARD_DEVIATION 1.46 • n=27 Participants
|
|
Hoehn and Yahr stage
Stage 0
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Hoehn and Yahr stage
Stage 1
|
28 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
51 Participants
n=27 Participants
|
|
Hoehn and Yahr stage
Stage 1.5
|
11 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
30 Participants
n=27 Participants
|
|
Hoehn and Yahr stage
Stage 2
|
71 Participants
n=93 Participants
|
71 Participants
n=4 Participants
|
142 Participants
n=27 Participants
|
|
Hoehn and Yahr stage
Stage 2.5
|
8 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Hoehn and Yahr stage
Stage 3
|
3 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Hoehn and Yahr stage
Stage 4
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Hoehn and Yahr stage
Stage 5
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Alcohol history
Does not drink
|
46 Participants
n=93 Participants
|
49 Participants
n=4 Participants
|
95 Participants
n=27 Participants
|
|
Alcohol history
Has an average consumption
|
75 Participants
n=93 Participants
|
76 Participants
n=4 Participants
|
151 Participants
n=27 Participants
|
|
Alcohol history
Fulfills criteria for Abuse/Dependence
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: up to 2 yearsPopulation: FAS LOCF - full analysis set with last observation carry forward
Expert panel of ophthalmologists assessed retinal deterioration by a review of the components of the comprehensive ophthalmology assessments
Outcome measures
| Measure |
Pramipexole
n=115 Participants
Flexible: 0.125 mg 3 times daily up to maximum tolerated
|
Ropinirole
n=119 Participants
Flexible: 0.25 mg 3 times daily up to maximum tolerated
|
|---|---|---|
|
Expert Panel Overall Assessment Following 2 Years on Drug
Have retinal deterioration
|
34 Participants
|
33 Participants
|
|
Expert Panel Overall Assessment Following 2 Years on Drug
Have no retinal deterioration
|
81 Participants
|
86 Participants
|
SECONDARY outcome
Timeframe: up to 1 yearsPopulation: FAS LOCF - full analysis set with last observation carry forward
Expert panel of ophthalmologists assessed retinal deterioration by a review of the components of the comprehensive ophthalmology assessments
Outcome measures
| Measure |
Pramipexole
n=115 Participants
Flexible: 0.125 mg 3 times daily up to maximum tolerated
|
Ropinirole
n=119 Participants
Flexible: 0.25 mg 3 times daily up to maximum tolerated
|
|---|---|---|
|
Expert Panel Overall Assessment Following 1 Year on Drug
Have retinal deterioration
|
28 Participants
|
21 Participants
|
|
Expert Panel Overall Assessment Following 1 Year on Drug
Have no retinal deterioration
|
87 Participants
|
98 Participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: TS - treated set
This scale is an investigator-completed assessment of the degree of complications arising from Parkinson's disease. The scale ranges from 0 (No signs) to 5 (Bedridden)
Outcome measures
| Measure |
Pramipexole
n=121 Participants
Flexible: 0.125 mg 3 times daily up to maximum tolerated
|
Ropinirole
n=125 Participants
Flexible: 0.25 mg 3 times daily up to maximum tolerated
|
|---|---|---|
|
Hoehn and Yahr Scale at Baseline
Stage 0
|
0 Participants
0
|
0 Participants
0
|
|
Hoehn and Yahr Scale at Baseline
Stage 1
|
28 Participants
|
23 Participants
|
|
Hoehn and Yahr Scale at Baseline
Stage 1.5
|
11 Participants
|
19 Participants
|
|
Hoehn and Yahr Scale at Baseline
Stage 2
|
71 Participants
|
71 Participants
|
|
Hoehn and Yahr Scale at Baseline
Stage 2.5
|
8 Participants
|
5 Participants
|
|
Hoehn and Yahr Scale at Baseline
Stage 3
|
3 Participants
|
7 Participants
|
|
Hoehn and Yahr Scale at Baseline
Stage 4
|
0 Participants
|
0 Participants
|
|
Hoehn and Yahr Scale at Baseline
Stage 5
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: TS - treated set
This scale is an investigator-completed assessment of the degree of complications arising from Parkinson's disease. The scale ranges from 0 (No signs) to 5 (Bedridden)
Outcome measures
| Measure |
Pramipexole
n=121 Participants
Flexible: 0.125 mg 3 times daily up to maximum tolerated
|
Ropinirole
n=125 Participants
Flexible: 0.25 mg 3 times daily up to maximum tolerated
|
|---|---|---|
|
Hoehn and Yahr Scale at 1 Year
Stage 0
|
1 Participants
1
|
1 Participants
1
|
|
Hoehn and Yahr Scale at 1 Year
Stage 1
|
33 Participants
|
22 Participants
|
|
Hoehn and Yahr Scale at 1 Year
Stage 1.5
|
9 Participants
|
16 Participants
|
|
Hoehn and Yahr Scale at 1 Year
Stage 2
|
70 Participants
|
72 Participants
|
|
Hoehn and Yahr Scale at 1 Year
Stage 2.5
|
8 Participants
|
8 Participants
|
|
Hoehn and Yahr Scale at 1 Year
Stage 3
|
0 Participants
|
6 Participants
|
|
Hoehn and Yahr Scale at 1 Year
Stage 4
|
0 Participants
|
0 Participants
|
|
Hoehn and Yahr Scale at 1 Year
Stage 5
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: TS - treated set
This scale is an investigator-completed assessment of the degree of complications arising from Parkinson's disease. The scale ranges from 0 (No signs) to 5 (Bedridden)
Outcome measures
| Measure |
Pramipexole
n=121 Participants
Flexible: 0.125 mg 3 times daily up to maximum tolerated
|
Ropinirole
n=125 Participants
Flexible: 0.25 mg 3 times daily up to maximum tolerated
|
|---|---|---|
|
Hoehn and Yahr Scale at 2 Years
Stage 1.5
|
6 Participants
|
12 Participants
|
|
Hoehn and Yahr Scale at 2 Years
Stage 0
|
1 Participants
1
|
0 Participants
0
|
|
Hoehn and Yahr Scale at 2 Years
Stage 1
|
27 Participants
|
23 Participants
|
|
Hoehn and Yahr Scale at 2 Years
Stage 2
|
74 Participants
|
73 Participants
|
|
Hoehn and Yahr Scale at 2 Years
Stage 2.5
|
10 Participants
|
10 Participants
|
|
Hoehn and Yahr Scale at 2 Years
Stage 3
|
3 Participants
|
7 Participants
|
|
Hoehn and Yahr Scale at 2 Years
Stage 4
|
0 Participants
|
0 Participants
|
|
Hoehn and Yahr Scale at 2 Years
Stage 5
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: TS - treated set
Part II of the UPDRS collected retrospective information on patient functioning in various activities of daily living. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 52.
Outcome measures
| Measure |
Pramipexole
n=121 Participants
Flexible: 0.125 mg 3 times daily up to maximum tolerated
|
Ropinirole
n=125 Participants
Flexible: 0.25 mg 3 times daily up to maximum tolerated
|
|---|---|---|
|
Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Total Score at Baseline
|
8.0 Score on a scale
Standard Deviation 3.8
|
9.5 Score on a scale
Standard Deviation 4.7
|
SECONDARY outcome
Timeframe: 1 yearPopulation: TS - treated set
Part II of the UPDRS collected retrospective information on patient functioning in various activities of daily living. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 52.
Outcome measures
| Measure |
Pramipexole
n=121 Participants
Flexible: 0.125 mg 3 times daily up to maximum tolerated
|
Ropinirole
n=125 Participants
Flexible: 0.25 mg 3 times daily up to maximum tolerated
|
|---|---|---|
|
Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Total Score at 1 Year
|
7.0 Score on a scale
Standard Deviation 4.3
|
8.4 Score on a scale
Standard Deviation 5.0
|
SECONDARY outcome
Timeframe: Baseline, 1 yearPopulation: TS - treated set
Part II of the UPDRS collected retrospective information on patient functioning in various activities of daily living. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 52.
Outcome measures
| Measure |
Pramipexole
n=121 Participants
Flexible: 0.125 mg 3 times daily up to maximum tolerated
|
Ropinirole
n=125 Participants
Flexible: 0.25 mg 3 times daily up to maximum tolerated
|
|---|---|---|
|
Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Change From Baseline in Total Score at 1 Year
|
-1.1 Score on a scale
Standard Deviation 3.4
|
-1.1 Score on a scale
Standard Deviation 3.6
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: TS - treated set
Part II of the UPDRS collected retrospective information on patient functioning in various activities of daily living. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 52.
Outcome measures
| Measure |
Pramipexole
n=121 Participants
Flexible: 0.125 mg 3 times daily up to maximum tolerated
|
Ropinirole
n=125 Participants
Flexible: 0.25 mg 3 times daily up to maximum tolerated
|
|---|---|---|
|
Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Total Score at 2 Years
|
8.4 Score on a scale
Standard Deviation 4.6
|
9.3 Score on a scale
Standard Deviation 5.2
|
SECONDARY outcome
Timeframe: Baseline, 2 yearPopulation: TS - treated set
Part II of the UPDRS collected retrospective information on patient functioning in various activities of daily living. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 52.
Outcome measures
| Measure |
Pramipexole
n=121 Participants
Flexible: 0.125 mg 3 times daily up to maximum tolerated
|
Ropinirole
n=125 Participants
Flexible: 0.25 mg 3 times daily up to maximum tolerated
|
|---|---|---|
|
Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Change From Baseline in Total Score at 2 Years
|
0.4 Score on a scale
Standard Deviation 3.7
|
-0.2 Score on a scale
Standard Deviation 4.0
|
SECONDARY outcome
Timeframe: BaselinePopulation: TS - treated set
Part III of the UPDRS contained the clinician-scored motor evaluation. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 56.
Outcome measures
| Measure |
Pramipexole
n=121 Participants
Flexible: 0.125 mg 3 times daily up to maximum tolerated
|
Ropinirole
n=125 Participants
Flexible: 0.25 mg 3 times daily up to maximum tolerated
|
|---|---|---|
|
Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Total Score at Baseline
|
20.7 Score on a scale
Standard Deviation 9.3
|
22.4 Score on a scale
Standard Deviation 10.2
|
SECONDARY outcome
Timeframe: 1 yearPopulation: TS - treated set
Part III of the UPDRS contained the clinician-scored motor evaluation. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 56.
Outcome measures
| Measure |
Pramipexole
n=121 Participants
Flexible: 0.125 mg 3 times daily up to maximum tolerated
|
Ropinirole
n=125 Participants
Flexible: 0.25 mg 3 times daily up to maximum tolerated
|
|---|---|---|
|
Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Total Score at 1 Year
|
17.7 Score on a scale
Standard Deviation 9.3
|
19.8 Score on a scale
Standard Deviation 10.9
|
SECONDARY outcome
Timeframe: Baseline, 1 yearPopulation: TS - treated set
Part III of the UPDRS contained the clinician-scored motor evaluation. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 56.
Outcome measures
| Measure |
Pramipexole
n=121 Participants
Flexible: 0.125 mg 3 times daily up to maximum tolerated
|
Ropinirole
n=125 Participants
Flexible: 0.25 mg 3 times daily up to maximum tolerated
|
|---|---|---|
|
Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Change From Baseline in Total Score at 1 Year
|
-3.0 Score on a scale
Standard Deviation 7.2
|
-2.6 Score on a scale
Standard Deviation 6.1
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: TS - treated set
Part III of the UPDRS contained the clinician-scored motor evaluation. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 56.
Outcome measures
| Measure |
Pramipexole
n=121 Participants
Flexible: 0.125 mg 3 times daily up to maximum tolerated
|
Ropinirole
n=125 Participants
Flexible: 0.25 mg 3 times daily up to maximum tolerated
|
|---|---|---|
|
Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Total Score at 2 Years
|
19.7 Score on a scale
Standard Deviation 9.9
|
20.9 Score on a scale
Standard Deviation 10.3
|
SECONDARY outcome
Timeframe: Baseline, 2 yearPopulation: TS - treated set
Part III of the UPDRS contained the clinician-scored motor evaluation. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 56.
Outcome measures
| Measure |
Pramipexole
n=121 Participants
Flexible: 0.125 mg 3 times daily up to maximum tolerated
|
Ropinirole
n=125 Participants
Flexible: 0.25 mg 3 times daily up to maximum tolerated
|
|---|---|---|
|
Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Change From Baseline in Total Score at 2 Years
|
-1.0 Score on a scale
Standard Deviation 7.9
|
-1.5 Score on a scale
Standard Deviation 7.7
|
SECONDARY outcome
Timeframe: BaselinePopulation: TS - treated set
This is the sum of Part II and Part III of the UPDRS. The total score ranged from 0 (Normal) to 108 (Extreme dysfunction).
Outcome measures
| Measure |
Pramipexole
n=121 Participants
Flexible: 0.125 mg 3 times daily up to maximum tolerated
|
Ropinirole
n=125 Participants
Flexible: 0.25 mg 3 times daily up to maximum tolerated
|
|---|---|---|
|
Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Total Score at Baseline
|
28.8 Score on a scale
Standard Deviation 11.6
|
31.9 Score on a scale
Standard Deviation 13.4
|
SECONDARY outcome
Timeframe: 1 yearPopulation: TS - treated set
This is the sum of Part II and Part III of the UPDRS. The total score ranged from 0 (Normal) to 108 (Extreme dysfunction).
Outcome measures
| Measure |
Pramipexole
n=121 Participants
Flexible: 0.125 mg 3 times daily up to maximum tolerated
|
Ropinirole
n=125 Participants
Flexible: 0.25 mg 3 times daily up to maximum tolerated
|
|---|---|---|
|
Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Total Score at 1 Year
|
24.7 Score on a scale
Standard Deviation 11.8
|
28.2 Score on a scale
Standard Deviation 14.5
|
SECONDARY outcome
Timeframe: Baseline, 1 yearPopulation: TS - treated set
This is the sum of Part II and Part III of the UPDRS. The total score ranged from 0 (Normal) to 108 (Extreme dysfunction).
Outcome measures
| Measure |
Pramipexole
n=121 Participants
Flexible: 0.125 mg 3 times daily up to maximum tolerated
|
Ropinirole
n=125 Participants
Flexible: 0.25 mg 3 times daily up to maximum tolerated
|
|---|---|---|
|
Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Change From Baseline in Total Score at 1 Year
|
-4.1 Score on a scale
Standard Deviation 8.9
|
-3.7 Score on a scale
Standard Deviation 8.2
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: TS - treated set
This is the sum of Part II and Part III of the UPDRS. The total score ranged from 0 (Normal) to 108 (Extreme dysfunction).
Outcome measures
| Measure |
Pramipexole
n=121 Participants
Flexible: 0.125 mg 3 times daily up to maximum tolerated
|
Ropinirole
n=125 Participants
Flexible: 0.25 mg 3 times daily up to maximum tolerated
|
|---|---|---|
|
Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Total Score at 2 Years
|
28.1 Score on a scale
Standard Deviation 12.9
|
30.2 Score on a scale
Standard Deviation 14.1
|
SECONDARY outcome
Timeframe: Baseline, 2 yearPopulation: TS - treated set
This is the sum of Part II and Part III of the UPDRS. The total score ranged from 0 (Normal) to 108 (Extreme dysfunction).
Outcome measures
| Measure |
Pramipexole
n=121 Participants
Flexible: 0.125 mg 3 times daily up to maximum tolerated
|
Ropinirole
n=125 Participants
Flexible: 0.25 mg 3 times daily up to maximum tolerated
|
|---|---|---|
|
Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Change From Baseline in Total Score at 2 Years
|
-0.7 Score on a scale
Standard Deviation 10.1
|
-1.7 Score on a scale
Standard Deviation 10.5
|
SECONDARY outcome
Timeframe: Screen (Baseline) and final visit (24 months)Population: TSlab - treated set with non-missing laboratory evaluations
Clinical relevant abnormalities for clinical laboratory evaluations Biochemistry and Haematology) and Vital Signs. New abnormal findings or worsening of baseline conditions were reported.
Outcome measures
| Measure |
Pramipexole
n=109 Participants
Flexible: 0.125 mg 3 times daily up to maximum tolerated
|
Ropinirole
n=110 Participants
Flexible: 0.25 mg 3 times daily up to maximum tolerated
|
|---|---|---|
|
Clinical Abnormal Findings: Clinical Laboratory Evaluations (Biochemistry and Haematology)and Vital Signs
Haematocrit - Decrease
|
1 participants
|
2 participants
|
|
Clinical Abnormal Findings: Clinical Laboratory Evaluations (Biochemistry and Haematology)and Vital Signs
Haemoglobin - Decrease
|
8 participants
|
5 participants
|
|
Clinical Abnormal Findings: Clinical Laboratory Evaluations (Biochemistry and Haematology)and Vital Signs
Eosinophils - Increase
|
4 participants
|
0 participants
|
|
Clinical Abnormal Findings: Clinical Laboratory Evaluations (Biochemistry and Haematology)and Vital Signs
Phosphate - Decrease
|
0 participants
|
2 participants
|
|
Clinical Abnormal Findings: Clinical Laboratory Evaluations (Biochemistry and Haematology)and Vital Signs
Calcium - Increase
|
1 participants
|
0 participants
|
|
Clinical Abnormal Findings: Clinical Laboratory Evaluations (Biochemistry and Haematology)and Vital Signs
Glucose - Decrease
|
4 participants
|
0 participants
|
Adverse Events
Pramipexole
Serious events: 22 serious events
Other events: 97 other events
Deaths: 0 deaths
Ropinirole
Serious events: 21 serious events
Other events: 101 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pramipexole
n=121 participants at risk
Flexible: 0.125 mg 3 times daily up to maximum tolerated
|
Ropinirole
n=125 participants at risk
Flexible: 0.25 mg 3 times daily up to maximum tolerated
|
|---|---|---|
|
Reproductive system and breast disorders
Cystocele
|
0.00%
0/121 • up to 24 months
|
0.80%
1/125 • up to 24 months
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.83%
1/121 • up to 24 months
|
0.00%
0/125 • up to 24 months
|
|
Reproductive system and breast disorders
Hyperthecosis
|
0.83%
1/121 • up to 24 months
|
0.00%
0/125 • up to 24 months
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.83%
1/121 • up to 24 months
|
0.00%
0/125 • up to 24 months
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.00%
0/121 • up to 24 months
|
0.80%
1/125 • up to 24 months
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.83%
1/121 • up to 24 months
|
0.00%
0/125 • up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.83%
1/121 • up to 24 months
|
0.00%
0/125 • up to 24 months
|
|
Vascular disorders
Thrombosis
|
0.00%
0/121 • up to 24 months
|
0.80%
1/125 • up to 24 months
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/121 • up to 24 months
|
0.80%
1/125 • up to 24 months
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.83%
1/121 • up to 24 months
|
0.00%
0/125 • up to 24 months
|
|
Cardiac disorders
Acute myocardial infarction
|
0.83%
1/121 • up to 24 months
|
0.00%
0/125 • up to 24 months
|
|
Cardiac disorders
Atrial fibrillation
|
1.7%
2/121 • up to 24 months
|
0.80%
1/125 • up to 24 months
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/121 • up to 24 months
|
0.80%
1/125 • up to 24 months
|
|
Cardiac disorders
Cardiac failure congestive
|
1.7%
2/121 • up to 24 months
|
0.00%
0/125 • up to 24 months
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/121 • up to 24 months
|
1.6%
2/125 • up to 24 months
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.83%
1/121 • up to 24 months
|
0.00%
0/125 • up to 24 months
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/121 • up to 24 months
|
0.80%
1/125 • up to 24 months
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/121 • up to 24 months
|
0.80%
1/125 • up to 24 months
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/121 • up to 24 months
|
0.80%
1/125 • up to 24 months
|
|
General disorders
Chest discomfort
|
0.00%
0/121 • up to 24 months
|
1.6%
2/125 • up to 24 months
|
|
Hepatobiliary disorders
Biliary colic
|
0.83%
1/121 • up to 24 months
|
0.00%
0/125 • up to 24 months
|
|
Hepatobiliary disorders
Biliary dyskinesia
|
0.83%
1/121 • up to 24 months
|
0.00%
0/125 • up to 24 months
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.83%
1/121 • up to 24 months
|
0.00%
0/125 • up to 24 months
|
|
Immune system disorders
Hypersensitivity
|
0.83%
1/121 • up to 24 months
|
0.00%
0/125 • up to 24 months
|
|
Infections and infestations
Appendicitis
|
1.7%
2/121 • up to 24 months
|
0.00%
0/125 • up to 24 months
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/121 • up to 24 months
|
0.80%
1/125 • up to 24 months
|
|
Injury, poisoning and procedural complications
Fall
|
0.83%
1/121 • up to 24 months
|
0.00%
0/125 • up to 24 months
|
|
Injury, poisoning and procedural complications
Femur fracture
|
1.7%
2/121 • up to 24 months
|
0.00%
0/125 • up to 24 months
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/121 • up to 24 months
|
0.80%
1/125 • up to 24 months
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/121 • up to 24 months
|
0.80%
1/125 • up to 24 months
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.83%
1/121 • up to 24 months
|
0.00%
0/125 • up to 24 months
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.00%
0/121 • up to 24 months
|
0.80%
1/125 • up to 24 months
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
1.7%
2/121 • up to 24 months
|
0.00%
0/125 • up to 24 months
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/121 • up to 24 months
|
0.80%
1/125 • up to 24 months
|
|
Injury, poisoning and procedural complications
Pubis fracture
|
0.83%
1/121 • up to 24 months
|
0.00%
0/125 • up to 24 months
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.83%
1/121 • up to 24 months
|
0.00%
0/125 • up to 24 months
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.83%
1/121 • up to 24 months
|
1.6%
2/125 • up to 24 months
|
|
Injury, poisoning and procedural complications
Stab wound
|
0.83%
1/121 • up to 24 months
|
0.00%
0/125 • up to 24 months
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/121 • up to 24 months
|
0.80%
1/125 • up to 24 months
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/121 • up to 24 months
|
0.80%
1/125 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.83%
1/121 • up to 24 months
|
0.00%
0/125 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/121 • up to 24 months
|
0.80%
1/125 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.83%
1/121 • up to 24 months
|
0.00%
0/125 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.83%
1/121 • up to 24 months
|
0.00%
0/125 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.83%
1/121 • up to 24 months
|
0.00%
0/125 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.7%
2/121 • up to 24 months
|
1.6%
2/125 • up to 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
4.1%
5/121 • up to 24 months
|
1.6%
2/125 • up to 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/121 • up to 24 months
|
0.80%
1/125 • up to 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.00%
0/121 • up to 24 months
|
0.80%
1/125 • up to 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian granulosa-theca cell tumour
|
0.83%
1/121 • up to 24 months
|
0.00%
0/125 • up to 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.83%
1/121 • up to 24 months
|
0.80%
1/125 • up to 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer stage unspecified
|
0.83%
1/121 • up to 24 months
|
0.00%
0/125 • up to 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/121 • up to 24 months
|
1.6%
2/125 • up to 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.83%
1/121 • up to 24 months
|
0.00%
0/125 • up to 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
0/121 • up to 24 months
|
0.80%
1/125 • up to 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.83%
1/121 • up to 24 months
|
0.00%
0/125 • up to 24 months
|
|
Nervous system disorders
Brain mass
|
0.83%
1/121 • up to 24 months
|
0.00%
0/125 • up to 24 months
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/121 • up to 24 months
|
0.80%
1/125 • up to 24 months
|
|
Nervous system disorders
Syncope
|
0.00%
0/121 • up to 24 months
|
0.80%
1/125 • up to 24 months
|
|
Nervous system disorders
Transient global amnesia
|
0.00%
0/121 • up to 24 months
|
0.80%
1/125 • up to 24 months
|
|
Psychiatric disorders
Delirium
|
0.00%
0/121 • up to 24 months
|
0.80%
1/125 • up to 24 months
|
|
Psychiatric disorders
Delusion
|
0.00%
0/121 • up to 24 months
|
0.80%
1/125 • up to 24 months
|
|
Psychiatric disorders
Hallucination, visual
|
0.00%
0/121 • up to 24 months
|
0.80%
1/125 • up to 24 months
|
|
Psychiatric disorders
Psychotic disorder
|
0.83%
1/121 • up to 24 months
|
0.00%
0/125 • up to 24 months
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/121 • up to 24 months
|
0.80%
1/125 • up to 24 months
|
Other adverse events
| Measure |
Pramipexole
n=121 participants at risk
Flexible: 0.125 mg 3 times daily up to maximum tolerated
|
Ropinirole
n=125 participants at risk
Flexible: 0.25 mg 3 times daily up to maximum tolerated
|
|---|---|---|
|
Eye disorders
Vision blurred
|
5.8%
7/121 • up to 24 months
|
3.2%
4/125 • up to 24 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.5%
3/121 • up to 24 months
|
5.6%
7/125 • up to 24 months
|
|
Gastrointestinal disorders
Constipation
|
14.9%
18/121 • up to 24 months
|
20.8%
26/125 • up to 24 months
|
|
Gastrointestinal disorders
Diarrhoea
|
5.0%
6/121 • up to 24 months
|
7.2%
9/125 • up to 24 months
|
|
Gastrointestinal disorders
Dry mouth
|
3.3%
4/121 • up to 24 months
|
5.6%
7/125 • up to 24 months
|
|
Gastrointestinal disorders
Dyspepsia
|
3.3%
4/121 • up to 24 months
|
5.6%
7/125 • up to 24 months
|
|
Gastrointestinal disorders
Dysphagia
|
0.83%
1/121 • up to 24 months
|
6.4%
8/125 • up to 24 months
|
|
Gastrointestinal disorders
Nausea
|
25.6%
31/121 • up to 24 months
|
47.2%
59/125 • up to 24 months
|
|
Gastrointestinal disorders
Vomiting
|
2.5%
3/121 • up to 24 months
|
9.6%
12/125 • up to 24 months
|
|
General disorders
Chest pain
|
5.0%
6/121 • up to 24 months
|
5.6%
7/125 • up to 24 months
|
|
General disorders
Fatigue
|
22.3%
27/121 • up to 24 months
|
20.0%
25/125 • up to 24 months
|
|
General disorders
Oedema peripheral
|
18.2%
22/121 • up to 24 months
|
14.4%
18/125 • up to 24 months
|
|
Infections and infestations
Nasopharyngitis
|
14.0%
17/121 • up to 24 months
|
12.8%
16/125 • up to 24 months
|
|
Infections and infestations
Sinusitis
|
4.1%
5/121 • up to 24 months
|
5.6%
7/125 • up to 24 months
|
|
Infections and infestations
Upper respiratory tract infection
|
9.9%
12/121 • up to 24 months
|
10.4%
13/125 • up to 24 months
|
|
Infections and infestations
Urinary tract infection
|
5.8%
7/121 • up to 24 months
|
3.2%
4/125 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.4%
9/121 • up to 24 months
|
9.6%
12/125 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.0%
17/121 • up to 24 months
|
7.2%
9/125 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.8%
7/121 • up to 24 months
|
7.2%
9/125 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.5%
3/121 • up to 24 months
|
5.6%
7/125 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.7%
2/121 • up to 24 months
|
6.4%
8/125 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.9%
12/121 • up to 24 months
|
10.4%
13/125 • up to 24 months
|
|
Nervous system disorders
Dizziness
|
22.3%
27/121 • up to 24 months
|
28.0%
35/125 • up to 24 months
|
|
Nervous system disorders
Dizziness postural
|
7.4%
9/121 • up to 24 months
|
7.2%
9/125 • up to 24 months
|
|
Nervous system disorders
Headache
|
12.4%
15/121 • up to 24 months
|
21.6%
27/125 • up to 24 months
|
|
Nervous system disorders
Hypoaesthesia
|
4.1%
5/121 • up to 24 months
|
7.2%
9/125 • up to 24 months
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/121 • up to 24 months
|
8.0%
10/125 • up to 24 months
|
|
Nervous system disorders
Somnolence
|
43.8%
53/121 • up to 24 months
|
56.8%
71/125 • up to 24 months
|
|
Nervous system disorders
Sudden onset of sleep
|
9.1%
11/121 • up to 24 months
|
12.8%
16/125 • up to 24 months
|
|
Psychiatric disorders
Abnormal dreams
|
6.6%
8/121 • up to 24 months
|
5.6%
7/125 • up to 24 months
|
|
Psychiatric disorders
Anxiety
|
8.3%
10/121 • up to 24 months
|
11.2%
14/125 • up to 24 months
|
|
Psychiatric disorders
Depression
|
6.6%
8/121 • up to 24 months
|
12.0%
15/125 • up to 24 months
|
|
Psychiatric disorders
Insomnia
|
15.7%
19/121 • up to 24 months
|
21.6%
27/125 • up to 24 months
|
|
Psychiatric disorders
Sleep disorder
|
7.4%
9/121 • up to 24 months
|
8.0%
10/125 • up to 24 months
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
5.8%
7/121 • up to 24 months
|
3.2%
4/125 • up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.6%
8/121 • up to 24 months
|
5.6%
7/125 • up to 24 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.0%
6/121 • up to 24 months
|
8.0%
10/125 • up to 24 months
|
|
Vascular disorders
Hypertension
|
7.4%
9/121 • up to 24 months
|
8.0%
10/125 • up to 24 months
|
|
Vascular disorders
Orthostatic hypotension
|
8.3%
10/121 • up to 24 months
|
11.2%
14/125 • up to 24 months
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Other - Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
- Publication restrictions are in place
Restriction type: OTHER