Trial Outcomes & Findings for Long-term Safety Study of Open-label Pramipexole ER in Patients With Advanced PD (NCT NCT00577460)
NCT ID: NCT00577460
Last Updated: 2014-05-16
Results Overview
The aim of this study was to obtain long-term safety and tolerability data on pramipexole ER, in patients who have previously completed a pramipexole double blind study in advanced Parkinson's Disease (PD) (248.525 (NCT00466167)). Therefore these items were considered as a safety evaluation.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
391 participants
Primary outcome timeframe
80 weeks
Results posted on
2014-05-16
Participant Flow
Participant milestones
| Measure |
PPX ER (Previous Placebo)
Pramipexole ER Treatment with placebo in previous trial
|
PPX ER (Previous PPX ER)
Pramipexole ER Treatment with Pramipexole ER in previous trial
|
PPX ER (Previous PPX IR)
Pramipexole ER Treatment with Pramipexole Immediate Release (IR) in previous trial
|
|---|---|---|---|
|
Overall Study
STARTED
|
129
|
123
|
139
|
|
Overall Study
COMPLETED
|
113
|
104
|
112
|
|
Overall Study
NOT COMPLETED
|
16
|
19
|
27
|
Reasons for withdrawal
| Measure |
PPX ER (Previous Placebo)
Pramipexole ER Treatment with placebo in previous trial
|
PPX ER (Previous PPX ER)
Pramipexole ER Treatment with Pramipexole ER in previous trial
|
PPX ER (Previous PPX IR)
Pramipexole ER Treatment with Pramipexole Immediate Release (IR) in previous trial
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
11
|
7
|
14
|
|
Overall Study
Protocol Violation
|
0
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
3
|
4
|
|
Overall Study
Withdrawal by Subject
|
5
|
5
|
6
|
|
Overall Study
Other
|
0
|
3
|
2
|
Baseline Characteristics
Long-term Safety Study of Open-label Pramipexole ER in Patients With Advanced PD
Baseline characteristics by cohort
| Measure |
PPX ER (Previous Placebo)
n=129 Participants
Pramipexole ER Treatment with placebo in previous trial
|
PPX ER (Previous PPX ER)
n=123 Participants
Pramipexole ER Treatment with Pramipexole ER in previous trial
|
PPX ER (Previous PPX IR)
n=139 Participants
Pramipexole ER Treatment with Pramipexole IR in previous trial
|
Total
n=391 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
61.3 Years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
61.7 Years
STANDARD_DEVIATION 9.8 • n=7 Participants
|
61.8 Years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
61.6 Years
STANDARD_DEVIATION 9.7 • n=4 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
178 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
71 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
213 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 80 weeksPopulation: Patients from Treated Set (defined as all patients who were dispensed study drug and were documented to have at least one dose of investigational treatment)
The aim of this study was to obtain long-term safety and tolerability data on pramipexole ER, in patients who have previously completed a pramipexole double blind study in advanced Parkinson's Disease (PD) (248.525 (NCT00466167)). Therefore these items were considered as a safety evaluation.
Outcome measures
| Measure |
PPX ER (Previous PPX ER)
n=129 Participants
Pramipexole ER Treatment with Pramipexole ER in previous trial
|
PPX ER (Previous PPX IR)
n=123 Participants
Pramipexole ER Treatment with Pramipexole IR in previous trial
|
PPX ER (Previous PPX IR)
n=139 Participants
Pramipexole ER Treatment with Pramipexole IR in previous trial
|
Total PPX ER
Pramipexole ER, all patients
|
|---|---|---|---|---|
|
Percentage of Patients With Adverse Events, Adverse Drug Reactions, Serious Adverse Events
Percentage of Patients with Adverse Events
|
85.3 Percentage of participants
|
83.7 Percentage of participants
|
79.9 Percentage of participants
|
—
|
|
Percentage of Patients With Adverse Events, Adverse Drug Reactions, Serious Adverse Events
Percentage of Patients with Adverse Drug Reactions
|
52.7 Percentage of participants
|
48.8 Percentage of participants
|
45.3 Percentage of participants
|
—
|
|
Percentage of Patients With Adverse Events, Adverse Drug Reactions, Serious Adverse Events
Percentage of Patients with Serious Adverse Events
|
10.9 Percentage of participants
|
8.9 Percentage of participants
|
10.1 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: One weekPopulation: Patients from Full Analysis Set (FAS included all patients who were dispensed study medication, had received at least one dose of study drug and had provided any post-baseline efficacy assessment) and who maintain the final dose of the previous study
Unified Parkinson's Disease Rating Scale (UPDRS) Successfully switched means: UPDRS II+III baseline score \>20 without a relative worsening of UPDRS II+III score \> 15% from baseline or UPDRS II+III baseline score \<=20 without an absolute worsening of UPDRS II+III score \> 3 from baseline UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms
Outcome measures
| Measure |
PPX ER (Previous PPX ER)
n=105 Participants
Pramipexole ER Treatment with Pramipexole ER in previous trial
|
PPX ER (Previous PPX IR)
n=123 Participants
Pramipexole ER Treatment with Pramipexole IR in previous trial
|
PPX ER (Previous PPX IR)
Pramipexole ER Treatment with Pramipexole IR in previous trial
|
Total PPX ER
Pramipexole ER, all patients
|
|---|---|---|---|---|
|
Patients Successfully Switched From Pramipexole (PPX) IR or ER to ER Assessed on UPDRS II+III
|
88 Patients
|
106 Patients
|
—
|
—
|
SECONDARY outcome
Timeframe: OL Baseline and week 80Population: Patients from FAS with values of UPDRS II+III at week 80
UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms
Outcome measures
| Measure |
PPX ER (Previous PPX ER)
n=113 Participants
Pramipexole ER Treatment with Pramipexole ER in previous trial
|
PPX ER (Previous PPX IR)
n=102 Participants
Pramipexole ER Treatment with Pramipexole IR in previous trial
|
PPX ER (Previous PPX IR)
n=112 Participants
Pramipexole ER Treatment with Pramipexole IR in previous trial
|
Total PPX ER
Pramipexole ER, all patients
|
|---|---|---|---|---|
|
UPDRS II+III Change From Open Label (OL) Baseline
|
-3.6 Scores on a scale
Standard Error 1.5
|
1.1 Scores on a scale
Standard Error 1.6
|
2.5 Scores on a scale
Standard Error 1.5
|
—
|
SECONDARY outcome
Timeframe: Week 80Population: Patients from FAS with values of UPDRS II+III at week 80
A response means an improvement of \>=20% in UPDRS II+III from OL baseline UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms
Outcome measures
| Measure |
PPX ER (Previous PPX ER)
n=113 Participants
Pramipexole ER Treatment with Pramipexole ER in previous trial
|
PPX ER (Previous PPX IR)
n=102 Participants
Pramipexole ER Treatment with Pramipexole IR in previous trial
|
PPX ER (Previous PPX IR)
n=112 Participants
Pramipexole ER Treatment with Pramipexole IR in previous trial
|
Total PPX ER
Pramipexole ER, all patients
|
|---|---|---|---|---|
|
Number of Participants With UPDRS II+III Response
|
35 Patients
|
30 Patients
|
31 Patients
|
—
|
SECONDARY outcome
Timeframe: One weekPopulation: Patients from FAS and who maintain the final dose of the previous study
A patient was considered as successfully switched if he/she has converted to ER without a worsening of off time by more than 12.5% from baseline. Off-time is based on patient diary data and describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease).
Outcome measures
| Measure |
PPX ER (Previous PPX ER)
n=95 Participants
Pramipexole ER Treatment with Pramipexole ER in previous trial
|
PPX ER (Previous PPX IR)
n=110 Participants
Pramipexole ER Treatment with Pramipexole IR in previous trial
|
PPX ER (Previous PPX IR)
Pramipexole ER Treatment with Pramipexole IR in previous trial
|
Total PPX ER
Pramipexole ER, all patients
|
|---|---|---|---|---|
|
Number of Patients Successfully Switched From PPX IR or ER to ER Assessed on Off-time
|
57 Patients
|
70 Patients
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and week 80Population: Patients from FAS with values of UPDRS II+III at week 80
Percentage off-time based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). Off-time describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease). A negative change implies improvement
Outcome measures
| Measure |
PPX ER (Previous PPX ER)
n=108 Participants
Pramipexole ER Treatment with Pramipexole ER in previous trial
|
PPX ER (Previous PPX IR)
n=100 Participants
Pramipexole ER Treatment with Pramipexole IR in previous trial
|
PPX ER (Previous PPX IR)
n=108 Participants
Pramipexole ER Treatment with Pramipexole IR in previous trial
|
Total PPX ER
Pramipexole ER, all patients
|
|---|---|---|---|---|
|
Percentage Off Time During Waking Hours Total Score: Change From Baseline
|
-1.5 percentage during waking hours
Standard Error 2.0
|
-0.3 percentage during waking hours
Standard Error 2.1
|
1.7 percentage during waking hours
Standard Error 2.0
|
—
|
SECONDARY outcome
Timeframe: 80 weeksPopulation: Patients from FAS with values of off time during waking hours at 80 weeks
Response means \>=20% improvement relative to OL baseline in the % off-time during waking hours
Outcome measures
| Measure |
PPX ER (Previous PPX ER)
n=97 Participants
Pramipexole ER Treatment with Pramipexole ER in previous trial
|
PPX ER (Previous PPX IR)
n=91 Participants
Pramipexole ER Treatment with Pramipexole IR in previous trial
|
PPX ER (Previous PPX IR)
n=94 Participants
Pramipexole ER Treatment with Pramipexole IR in previous trial
|
Total PPX ER
n=282 Participants
Pramipexole ER, all patients
|
|---|---|---|---|---|
|
Number of Participants With Response in Percentage Off Time During Waking Hours
|
35 Patients
|
40 Patients
|
28 Patients
|
103 Patients
|
SECONDARY outcome
Timeframe: Baseline and week 80Population: Patients from FAS with values of on time during waking hours at week 80
Percentage on-time based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep. A positive change implies improvement.
Outcome measures
| Measure |
PPX ER (Previous PPX ER)
n=108 Participants
Pramipexole ER Treatment with Pramipexole ER in previous trial
|
PPX ER (Previous PPX IR)
n=100 Participants
Pramipexole ER Treatment with Pramipexole IR in previous trial
|
PPX ER (Previous PPX IR)
n=108 Participants
Pramipexole ER Treatment with Pramipexole IR in previous trial
|
Total PPX ER
Pramipexole ER, all patients
|
|---|---|---|---|---|
|
Percentage on Time Without Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks
|
-1.6 percentage during waking hours
Standard Error 2.5
|
2.9 percentage during waking hours
Standard Error 2.7
|
-2.0 percentage during waking hours
Standard Error 2.6
|
—
|
SECONDARY outcome
Timeframe: Baseline and week 80Population: Patients from FAS with values of on time during waking hours at week 80
Percentage on-time with non troublesome dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep. A positive change implies improvement
Outcome measures
| Measure |
PPX ER (Previous PPX ER)
n=108 Participants
Pramipexole ER Treatment with Pramipexole ER in previous trial
|
PPX ER (Previous PPX IR)
n=100 Participants
Pramipexole ER Treatment with Pramipexole IR in previous trial
|
PPX ER (Previous PPX IR)
n=108 Participants
Pramipexole ER Treatment with Pramipexole IR in previous trial
|
Total PPX ER
Pramipexole ER, all patients
|
|---|---|---|---|---|
|
Percentage on Time With Non Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks
|
3.8 percentage during waking hours
Standard Error 1.8
|
-2.7 percentage during waking hours
Standard Error 1.9
|
0.2 percentage during waking hours
Standard Error 1.8
|
—
|
SECONDARY outcome
Timeframe: Baseline and week 80Population: Patients from FAS with values of on time during waking hours at week 80
Percentage on-time without dyskinesia or with non troublesome dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep. A positive change implies improvement
Outcome measures
| Measure |
PPX ER (Previous PPX ER)
n=108 Participants
Pramipexole ER Treatment with Pramipexole ER in previous trial
|
PPX ER (Previous PPX IR)
n=100 Participants
Pramipexole ER Treatment with Pramipexole IR in previous trial
|
PPX ER (Previous PPX IR)
n=108 Participants
Pramipexole ER Treatment with Pramipexole IR in previous trial
|
Total PPX ER
Pramipexole ER, all patients
|
|---|---|---|---|---|
|
Percentage on Time Without Dyskinesia or With Non Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks
|
1.8 percentage during waking hours
Standard Error 2.2
|
0.7 percentage during waking hours
Standard Error 2.3
|
-0.9 percentage during waking hours
Standard Error 2.3
|
—
|
SECONDARY outcome
Timeframe: Baseline and week 80Population: Patients from FAS with values of on time during waking hours at week 80
Percentage on-time with troublesome dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep. A positive change implies improvement
Outcome measures
| Measure |
PPX ER (Previous PPX ER)
n=108 Participants
Pramipexole ER Treatment with Pramipexole ER in previous trial
|
PPX ER (Previous PPX IR)
n=100 Participants
Pramipexole ER Treatment with Pramipexole IR in previous trial
|
PPX ER (Previous PPX IR)
n=108 Participants
Pramipexole ER Treatment with Pramipexole IR in previous trial
|
Total PPX ER
Pramipexole ER, all patients
|
|---|---|---|---|---|
|
Percentage on Time With Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks
|
-0.4 percentage during waking hours
Standard Error 1.0
|
-0.3 percentage during waking hours
Standard Error 1.1
|
-0.7 percentage during waking hours
Standard Error 1.1
|
—
|
SECONDARY outcome
Timeframe: 32 weeksPopulation: Patients from FAS with values of CGI-I at week 32
Clinical Global Impression of Improvement (CGI-I), CGI-I scores ranging from '1' (very much improved) to '7' (very much worse). For patients previously treated with Placebo, all patients with at least "much improved" were considered as responders. For patients previously treated with PPX ER or IR, all patients with no change to very much improved were considered as responders
Outcome measures
| Measure |
PPX ER (Previous PPX ER)
n=124 Participants
Pramipexole ER Treatment with Pramipexole ER in previous trial
|
PPX ER (Previous PPX IR)
n=115 Participants
Pramipexole ER Treatment with Pramipexole IR in previous trial
|
PPX ER (Previous PPX IR)
n=124 Participants
Pramipexole ER Treatment with Pramipexole IR in previous trial
|
Total PPX ER
n=363 Participants
Pramipexole ER, all patients
|
|---|---|---|---|---|
|
Number of Participants With Response in CGI-I
|
50 Patients
|
106 Patients
|
114 Patients
|
270 Patients
|
SECONDARY outcome
Timeframe: 32 weeksPopulation: Patients from FAS with values of PGI-I at week 32
Patient Global Impression of Improvement (PGI-I), PGI-I scores ranging from '1' (very much better) to '7' (very much worse). For patients previously treated with Placebo, all patients with at least "much better" were considered as responders. For patients previously treated with PPX ER or IR, all patients with no change to very much better were considered as responders
Outcome measures
| Measure |
PPX ER (Previous PPX ER)
n=124 Participants
Pramipexole ER Treatment with Pramipexole ER in previous trial
|
PPX ER (Previous PPX IR)
n=115 Participants
Pramipexole ER Treatment with Pramipexole IR in previous trial
|
PPX ER (Previous PPX IR)
n=124 Participants
Pramipexole ER Treatment with Pramipexole IR in previous trial
|
Total PPX ER
n=363 Participants
Pramipexole ER, all patients
|
|---|---|---|---|---|
|
Number of Participants With Response in PGI-I
|
45 Patients
|
102 Patients
|
113 Patients
|
260 Patients
|
SECONDARY outcome
Timeframe: 32 weeksPopulation: Patients from FAS with values of PGI-I for early morning off symptoms at week 32
Patient Global Impression of Improvement (PGI-I) for early morning off symptoms, PGI-I scores ranging from '1' (very much better) to '7' (very much worse). For patients previously treated with Placebo, all patients with at least "much better" were considered as responders. For patients previously treated with PPX ER or IR, all patients with no change to very much better were considered as responders
Outcome measures
| Measure |
PPX ER (Previous PPX ER)
n=125 Participants
Pramipexole ER Treatment with Pramipexole ER in previous trial
|
PPX ER (Previous PPX IR)
n=116 Participants
Pramipexole ER Treatment with Pramipexole IR in previous trial
|
PPX ER (Previous PPX IR)
n=125 Participants
Pramipexole ER Treatment with Pramipexole IR in previous trial
|
Total PPX ER
n=366 Participants
Pramipexole ER, all patients
|
|---|---|---|---|---|
|
Number of Participants With Response in PGI-I for Early Morning Off Symptoms
|
45 Patients
|
103 Patients
|
112 Patients
|
260 Patients
|
SECONDARY outcome
Timeframe: OL baseline and week 80Population: Patients from FAS with values of UPDRS I at week 80
UPDRS I ranging from 0 (normal) to 16 (severe). UPDRS I measures Mentation, Behavior and Mood
Outcome measures
| Measure |
PPX ER (Previous PPX ER)
n=113 Participants
Pramipexole ER Treatment with Pramipexole ER in previous trial
|
PPX ER (Previous PPX IR)
n=104 Participants
Pramipexole ER Treatment with Pramipexole IR in previous trial
|
PPX ER (Previous PPX IR)
n=113 Participants
Pramipexole ER Treatment with Pramipexole IR in previous trial
|
Total PPX ER
Pramipexole ER, all patients
|
|---|---|---|---|---|
|
UPDRS I Total Score and Change From OL Baseline at Week 80
|
0.1 units on a scale
Standard Error 0.2
|
0.5 units on a scale
Standard Error 0.2
|
0.5 units on a scale
Standard Error 0.2
|
—
|
SECONDARY outcome
Timeframe: OL baseline and week 80Population: Patients from FAS with values of UPDRS II at week 80
UPDRS II ranging from 0 (normal) to 52 (severe). UPDRS Part II is calculated as the average of UPDRS part II at on and UPDRS part II at off-period for each of the 13 activities
Outcome measures
| Measure |
PPX ER (Previous PPX ER)
n=113 Participants
Pramipexole ER Treatment with Pramipexole ER in previous trial
|
PPX ER (Previous PPX IR)
n=102 Participants
Pramipexole ER Treatment with Pramipexole IR in previous trial
|
PPX ER (Previous PPX IR)
n=112 Participants
Pramipexole ER Treatment with Pramipexole IR in previous trial
|
Total PPX ER
Pramipexole ER, all patients
|
|---|---|---|---|---|
|
UPDRS II Total Score and Change From OL Baseline at Week 80
|
-0.4 units on a scale
Standard Error 0.5
|
0.4 units on a scale
Standard Error 0.6
|
1.0 units on a scale
Standard Error 0.5
|
—
|
SECONDARY outcome
Timeframe: OL baseline and week 80Population: Patients from FAS with values of UPDRS III at week 80
UPDRS III ranging from 0 (normal) to 108 (severe). UPDRS part III measures motor symptoms
Outcome measures
| Measure |
PPX ER (Previous PPX ER)
n=113 Participants
Pramipexole ER Treatment with Pramipexole ER in previous trial
|
PPX ER (Previous PPX IR)
n=104 Participants
Pramipexole ER Treatment with Pramipexole IR in previous trial
|
PPX ER (Previous PPX IR)
n=113 Participants
Pramipexole ER Treatment with Pramipexole IR in previous trial
|
Total PPX ER
Pramipexole ER, all patients
|
|---|---|---|---|---|
|
UPDRS III Total Score and Change From OL Baseline at Week 80
|
-3.1 units on a scale
Standard Error 1.1
|
0.7 units on a scale
Standard Error 1.1
|
1.3 units on a scale
Standard Error 1.1
|
—
|
SECONDARY outcome
Timeframe: OL baseline and week 80Population: Patients from FAS with values of UPDRS IV at week 80
UPDRS IV ranging from 0 (normal) to 23 (severe). UPDRS IV measures complications of therapy
Outcome measures
| Measure |
PPX ER (Previous PPX ER)
n=113 Participants
Pramipexole ER Treatment with Pramipexole ER in previous trial
|
PPX ER (Previous PPX IR)
n=104 Participants
Pramipexole ER Treatment with Pramipexole IR in previous trial
|
PPX ER (Previous PPX IR)
n=113 Participants
Pramipexole ER Treatment with Pramipexole IR in previous trial
|
Total PPX ER
Pramipexole ER, all patients
|
|---|---|---|---|---|
|
UPDRS IV Total Score and Change From OL Baseline at Week 80
|
0.0 Unit on a scale
Standard Error 0.2
|
-0.0 Unit on a scale
Standard Error 0.3
|
0.2 Unit on a scale
Standard Error 0.2
|
—
|
SECONDARY outcome
Timeframe: OL baseline and week 80Population: Patients from FAS with values of PFS-16 score at week 80
PFS-16 (Parkinson fatigue scale) ranging from 16 (better perceived health status) to 80 (severe symptoms of the disease) measuring aspects of fatigue that are relevant to patients with PD
Outcome measures
| Measure |
PPX ER (Previous PPX ER)
n=116 Participants
Pramipexole ER Treatment with Pramipexole ER in previous trial
|
PPX ER (Previous PPX IR)
n=106 Participants
Pramipexole ER Treatment with Pramipexole IR in previous trial
|
PPX ER (Previous PPX IR)
n=114 Participants
Pramipexole ER Treatment with Pramipexole IR in previous trial
|
Total PPX ER
Pramipexole ER, all patients
|
|---|---|---|---|---|
|
Parkinson Fatigue Scale (PFS-16) Score and Change From OL Baseline at Week 80
|
-0.3 Unit on a scale
Standard Error 1.5
|
3.8 Unit on a scale
Standard Error 1.6
|
3.5 Unit on a scale
Standard Error 1.6
|
—
|
SECONDARY outcome
Timeframe: OL baseline and week 80Population: Patients from FAS with documentation of levodopa (L-DOPA) daily dose at week 80
Outcome measures
| Measure |
PPX ER (Previous PPX ER)
n=125 Participants
Pramipexole ER Treatment with Pramipexole ER in previous trial
|
PPX ER (Previous PPX IR)
n=114 Participants
Pramipexole ER Treatment with Pramipexole IR in previous trial
|
PPX ER (Previous PPX IR)
n=132 Participants
Pramipexole ER Treatment with Pramipexole IR in previous trial
|
Total PPX ER
n=371 Participants
Pramipexole ER, all patients
|
|---|---|---|---|---|
|
Number of Participants With L-dopa Daily Dose Change: Change From OL Baseline at Week 80
No change
|
93 Patients
|
84 Patients
|
93 Patients
|
270 Patients
|
|
Number of Participants With L-dopa Daily Dose Change: Change From OL Baseline at Week 80
Decrease
|
24 Patients
|
12 Patients
|
12 Patients
|
48 Patients
|
|
Number of Participants With L-dopa Daily Dose Change: Change From OL Baseline at Week 80
Increase
|
8 Patients
|
18 Patients
|
27 Patients
|
53 Patients
|
SECONDARY outcome
Timeframe: OL baseline and week 80Population: Patients from Treated Set (all patients who were dispensed study drug and were documented to have at least one dose of investigational treatment) and treated until week 80
Outcome measures
| Measure |
PPX ER (Previous PPX ER)
n=125 Participants
Pramipexole ER Treatment with Pramipexole ER in previous trial
|
PPX ER (Previous PPX IR)
n=115 Participants
Pramipexole ER Treatment with Pramipexole IR in previous trial
|
PPX ER (Previous PPX IR)
n=126 Participants
Pramipexole ER Treatment with Pramipexole IR in previous trial
|
Total PPX ER
n=366 Participants
Pramipexole ER, all patients
|
|---|---|---|---|---|
|
Number of Participants With Changes in Pramipexole Doses After 80 Weeks Compared to Pramipexole Dose at OL Baseline
Reduced
|
56 Patients
|
33 Patients
|
26 Patients
|
115 Patients
|
|
Number of Participants With Changes in Pramipexole Doses After 80 Weeks Compared to Pramipexole Dose at OL Baseline
Unchanged
|
40 Patients
|
43 Patients
|
53 Patients
|
136 Patients
|
|
Number of Participants With Changes in Pramipexole Doses After 80 Weeks Compared to Pramipexole Dose at OL Baseline
Increased
|
29 Patients
|
39 Patients
|
47 Patients
|
115 Patients
|
SECONDARY outcome
Timeframe: 80 weeksPopulation: The Treated Set (TS) included all patients who were dispensed study drug and were documented to have at least one dose of investigational treatment
Outcome measures
| Measure |
PPX ER (Previous PPX ER)
n=129 Participants
Pramipexole ER Treatment with Pramipexole ER in previous trial
|
PPX ER (Previous PPX IR)
n=123 Participants
Pramipexole ER Treatment with Pramipexole IR in previous trial
|
PPX ER (Previous PPX IR)
n=139 Participants
Pramipexole ER Treatment with Pramipexole IR in previous trial
|
Total PPX ER
n=391 Participants
Pramipexole ER, all patients
|
|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events
|
14 Patients
|
11 Patients
|
14 Patients
|
39 Patients
|
SECONDARY outcome
Timeframe: OL Baseline and Week 80Population: Vital Signs Treated Set - All participants treated with study drug and have both baseline and week 80 vital sign data
Outcome measures
| Measure |
PPX ER (Previous PPX ER)
n=125 Participants
Pramipexole ER Treatment with Pramipexole ER in previous trial
|
PPX ER (Previous PPX IR)
n=114 Participants
Pramipexole ER Treatment with Pramipexole IR in previous trial
|
PPX ER (Previous PPX IR)
n=132 Participants
Pramipexole ER Treatment with Pramipexole IR in previous trial
|
Total PPX ER
Pramipexole ER, all patients
|
|---|---|---|---|---|
|
Supine Diastolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set
OL Baseline
|
77.4 mm Hg
Standard Deviation 8.9
|
77.3 mm Hg
Standard Deviation 8.6
|
77.6 mm Hg
Standard Deviation 9.4
|
—
|
|
Supine Diastolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set
End of OL
|
77.4 mm Hg
Standard Deviation 8.9
|
78.3 mm Hg
Standard Deviation 8.9
|
77.2 mm Hg
Standard Deviation 8.3
|
—
|
SECONDARY outcome
Timeframe: OL Baseline and Week 80Population: Vital Signs Treated Set - All participants treated with study drug and have both baseline and week 80 vital sign data
Outcome measures
| Measure |
PPX ER (Previous PPX ER)
n=125 Participants
Pramipexole ER Treatment with Pramipexole ER in previous trial
|
PPX ER (Previous PPX IR)
n=113 Participants
Pramipexole ER Treatment with Pramipexole IR in previous trial
|
PPX ER (Previous PPX IR)
n=131 Participants
Pramipexole ER Treatment with Pramipexole IR in previous trial
|
Total PPX ER
Pramipexole ER, all patients
|
|---|---|---|---|---|
|
Standing Diastolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set
OL Baseline
|
77.8 mm Hg
Standard Deviation 9.2
|
77.3 mm Hg
Standard Deviation 9.1
|
77.6 mm Hg
Standard Deviation 9.9
|
—
|
|
Standing Diastolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set
End of OL
|
77.6 mm Hg
Standard Deviation 9.1
|
78.1 mm Hg
Standard Deviation 9.3
|
76.4 mm Hg
Standard Deviation 9.7
|
—
|
SECONDARY outcome
Timeframe: OL Baseline and Week 80Population: Vital Signs Treated Set - All participants treated with study drug and have both baseline and week 80 vital sign data
Outcome measures
| Measure |
PPX ER (Previous PPX ER)
n=125 Participants
Pramipexole ER Treatment with Pramipexole ER in previous trial
|
PPX ER (Previous PPX IR)
n=114 Participants
Pramipexole ER Treatment with Pramipexole IR in previous trial
|
PPX ER (Previous PPX IR)
n=132 Participants
Pramipexole ER Treatment with Pramipexole IR in previous trial
|
Total PPX ER
Pramipexole ER, all patients
|
|---|---|---|---|---|
|
Supine Systolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set
OL Baseline
|
121.6 mm Hg
Standard Deviation 12.2
|
124.5 mm Hg
Standard Deviation 15.4
|
125.7 mm Hg
Standard Deviation 14.8
|
—
|
|
Supine Systolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set
End of OL
|
124.2 mm Hg
Standard Deviation 13.5
|
123.8 mm Hg
Standard Deviation 14.2
|
124.4 mm Hg
Standard Deviation 14.7
|
—
|
SECONDARY outcome
Timeframe: OL Baseline and Week 80Population: Vital Signs Treated Set - All participants treated with study drug and have both baseline and week 80 vital sign data
Outcome measures
| Measure |
PPX ER (Previous PPX ER)
n=125 Participants
Pramipexole ER Treatment with Pramipexole ER in previous trial
|
PPX ER (Previous PPX IR)
n=113 Participants
Pramipexole ER Treatment with Pramipexole IR in previous trial
|
PPX ER (Previous PPX IR)
n=131 Participants
Pramipexole ER Treatment with Pramipexole IR in previous trial
|
Total PPX ER
Pramipexole ER, all patients
|
|---|---|---|---|---|
|
Standing Systolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set
OL Baseline
|
120.2 mm Hg
Standard Deviation 13.9
|
121.1 mm Hg
Standard Deviation 16.4
|
120.9 mm Hg
Standard Deviation 15.9
|
—
|
|
Standing Systolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set
End of OL
|
121.9 mm Hg
Standard Deviation 15.0
|
121.6 mm Hg
Standard Deviation 14.3
|
120.5 mm Hg
Standard Deviation 16.0
|
—
|
SECONDARY outcome
Timeframe: OL Baseline and Week 80Population: Vital Signs Treated Set - All participants treated with study drug and have both baseline and week 80 vital sign data
Outcome measures
| Measure |
PPX ER (Previous PPX ER)
n=125 Participants
Pramipexole ER Treatment with Pramipexole ER in previous trial
|
PPX ER (Previous PPX IR)
n=114 Participants
Pramipexole ER Treatment with Pramipexole IR in previous trial
|
PPX ER (Previous PPX IR)
n=132 Participants
Pramipexole ER Treatment with Pramipexole IR in previous trial
|
Total PPX ER
Pramipexole ER, all patients
|
|---|---|---|---|---|
|
Supine Pulse Rate, Baseline and Week 80, Vital Signs Treated Set
End of OL
|
75.8 beats per minute
Standard Deviation 9.0
|
74.2 beats per minute
Standard Deviation 7.9
|
74.4 beats per minute
Standard Deviation 10.0
|
—
|
|
Supine Pulse Rate, Baseline and Week 80, Vital Signs Treated Set
OL Baseline
|
73.6 beats per minute
Standard Deviation 9.6
|
72.6 beats per minute
Standard Deviation 9.2
|
73.2 beats per minute
Standard Deviation 9.0
|
—
|
SECONDARY outcome
Timeframe: OL Baseline and Week 80Population: Vital Signs Treated Set - All participants treated with study drug and have both baseline and week 80 vital sign data
Outcome measures
| Measure |
PPX ER (Previous PPX ER)
n=125 Participants
Pramipexole ER Treatment with Pramipexole ER in previous trial
|
PPX ER (Previous PPX IR)
n=113 Participants
Pramipexole ER Treatment with Pramipexole IR in previous trial
|
PPX ER (Previous PPX IR)
n=131 Participants
Pramipexole ER Treatment with Pramipexole IR in previous trial
|
Total PPX ER
Pramipexole ER, all patients
|
|---|---|---|---|---|
|
Standing Pulse Rate, Baseline and Week 80, Vital Signs Treated Set
OL Baseline
|
78.3 beats per minute
Standard Deviation 10.7
|
78.0 beats per minute
Standard Deviation 9.5
|
77.7 beats per minute
Standard Deviation 9.9
|
—
|
|
Standing Pulse Rate, Baseline and Week 80, Vital Signs Treated Set
End of OL
|
79.3 beats per minute
Standard Deviation 8.7
|
77.7 beats per minute
Standard Deviation 7.5
|
78.8 beats per minute
Standard Deviation 10.4
|
—
|
SECONDARY outcome
Timeframe: OL Baseline and Week 80Population: Vital Signs Treated Set - All participants treated with study drug and have both baseline and week 80 vital sign data
Outcome measures
| Measure |
PPX ER (Previous PPX ER)
n=55 Participants
Pramipexole ER Treatment with Pramipexole ER in previous trial
|
PPX ER (Previous PPX IR)
n=52 Participants
Pramipexole ER Treatment with Pramipexole IR in previous trial
|
PPX ER (Previous PPX IR)
n=62 Participants
Pramipexole ER Treatment with Pramipexole IR in previous trial
|
Total PPX ER
Pramipexole ER, all patients
|
|---|---|---|---|---|
|
Body Weight of Female Patients, Baseline and Week 80, Vital Signs Treated Set
OL Baseline
|
61.9 kg
Standard Deviation 13.0
|
61.7 kg
Standard Deviation 14.0
|
63.8 kg
Standard Deviation 14.6
|
—
|
|
Body Weight of Female Patients, Baseline and Week 80, Vital Signs Treated Set
End of OL
|
63.6 kg
Standard Deviation 13.8
|
61.7 kg
Standard Deviation 15.0
|
63.6 kg
Standard Deviation 16.0
|
—
|
SECONDARY outcome
Timeframe: OL Baseline and Week 80Population: Vital Signs Treated Set - All participants treated with study drug and have both baseline and week 80 vital sign data
Outcome measures
| Measure |
PPX ER (Previous PPX ER)
n=70 Participants
Pramipexole ER Treatment with Pramipexole ER in previous trial
|
PPX ER (Previous PPX IR)
n=62 Participants
Pramipexole ER Treatment with Pramipexole IR in previous trial
|
PPX ER (Previous PPX IR)
n=70 Participants
Pramipexole ER Treatment with Pramipexole IR in previous trial
|
Total PPX ER
Pramipexole ER, all patients
|
|---|---|---|---|---|
|
Body Weight of Male Patients, Baseline and Week 80, Vital Signs Treated Set
OL Baseline
|
73.0 kg
Standard Deviation 15.7
|
72.1 kg
Standard Deviation 12.2
|
70.8 kg
Standard Deviation 13.2
|
—
|
|
Body Weight of Male Patients, Baseline and Week 80, Vital Signs Treated Set
End of OL
|
73.9 kg
Standard Deviation 16.4
|
72.7 kg
Standard Deviation 12.5
|
72.0 kg
Standard Deviation 14.0
|
—
|
SECONDARY outcome
Timeframe: OL Baseline and Week 80ESS Total score ranges from zero (best) to 24 (worst); scale has 8 items, each rated from zero (no chance of dozing) to 3 (high chance of dozing)
Outcome measures
| Measure |
PPX ER (Previous PPX ER)
n=125 Participants
Pramipexole ER Treatment with Pramipexole ER in previous trial
|
PPX ER (Previous PPX IR)
n=113 Participants
Pramipexole ER Treatment with Pramipexole IR in previous trial
|
PPX ER (Previous PPX IR)
n=130 Participants
Pramipexole ER Treatment with Pramipexole IR in previous trial
|
Total PPX ER
Pramipexole ER, all patients
|
|---|---|---|---|---|
|
Epworth Sleepiness Scale (ESS), Baseline and End of Open Label, Treated Set
OL Baseline
|
7.2 units on a scale
Standard Deviation 4.6
|
8.1 units on a scale
Standard Deviation 4.1
|
8.1 units on a scale
Standard Deviation 4.9
|
—
|
|
Epworth Sleepiness Scale (ESS), Baseline and End of Open Label, Treated Set
Change from baseline at end of OL
|
0.5 units on a scale
Standard Deviation 5.1
|
1.2 units on a scale
Standard Deviation 4.7
|
1.2 units on a scale
Standard Deviation 4.8
|
—
|
SECONDARY outcome
Timeframe: Baseline, 80 weeksPopulation: Treated Set - all patients dispensed drug and documented to have taken at least one dose
The mMIDI is a semi-structured interview designed to assess impulsive control disorders. The scale was modified to focus behaviors of: pathological gambling, compulsive buying and compulsive sexual behavioral.
Outcome measures
| Measure |
PPX ER (Previous PPX ER)
n=129 Participants
Pramipexole ER Treatment with Pramipexole ER in previous trial
|
PPX ER (Previous PPX IR)
n=123 Participants
Pramipexole ER Treatment with Pramipexole IR in previous trial
|
PPX ER (Previous PPX IR)
n=139 Participants
Pramipexole ER Treatment with Pramipexole IR in previous trial
|
Total PPX ER
Pramipexole ER, all patients
|
|---|---|---|---|---|
|
Modified Minnesota Impulsive Disorder Interview (mMIDI), Frequency of Patients With at Least One Abnormal Behavior, Treated Set
Abnormal behavior - pathological gambling
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Modified Minnesota Impulsive Disorder Interview (mMIDI), Frequency of Patients With at Least One Abnormal Behavior, Treated Set
Abnormal behavior - compulsive buying
|
2 participants
|
0 participants
|
2 participants
|
—
|
|
Modified Minnesota Impulsive Disorder Interview (mMIDI), Frequency of Patients With at Least One Abnormal Behavior, Treated Set
Abnormal behavior - compulsive sexual behavior
|
2 participants
|
2 participants
|
0 participants
|
—
|
Adverse Events
PPX ER (Previous Placebo)
Serious events: 14 serious events
Other events: 87 other events
Deaths: 0 deaths
PPX ER (Previous PPX ER)
Serious events: 11 serious events
Other events: 74 other events
Deaths: 0 deaths
PPX ER (Previous PPX IR)
Serious events: 14 serious events
Other events: 81 other events
Deaths: 0 deaths
Total PPX ER
Serious events: 39 serious events
Other events: 242 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PPX ER (Previous Placebo)
n=129 participants at risk
Pramipexole ER Treatment with placebo in previous trial
|
PPX ER (Previous PPX ER)
n=123 participants at risk
Pramipexole ER Treatment with Pramipexole ER in previous trial
|
PPX ER (Previous PPX IR)
n=139 participants at risk
Pramipexole ER Treatment with Pramipexole IR in previous trial
|
Total PPX ER
n=391 participants at risk
Pramipexole ER, all patients
|
|---|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/129 • 80 weeks
|
0.81%
1/123 • 80 weeks
|
0.00%
0/139 • 80 weeks
|
0.26%
1/391 • 80 weeks
|
|
Cardiac disorders
Aortic valve stenosis
|
0.78%
1/129 • 80 weeks
|
0.00%
0/123 • 80 weeks
|
0.00%
0/139 • 80 weeks
|
0.26%
1/391 • 80 weeks
|
|
Cardiac disorders
Cardiac arrest
|
0.78%
1/129 • 80 weeks
|
0.00%
0/123 • 80 weeks
|
0.00%
0/139 • 80 weeks
|
0.26%
1/391 • 80 weeks
|
|
Cardiac disorders
Cardiac failure congestive
|
0.78%
1/129 • 80 weeks
|
0.00%
0/123 • 80 weeks
|
0.00%
0/139 • 80 weeks
|
0.26%
1/391 • 80 weeks
|
|
Cardiac disorders
Cardiovascular insufficiency
|
0.78%
1/129 • 80 weeks
|
0.00%
0/123 • 80 weeks
|
0.00%
0/139 • 80 weeks
|
0.26%
1/391 • 80 weeks
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/129 • 80 weeks
|
0.81%
1/123 • 80 weeks
|
0.00%
0/139 • 80 weeks
|
0.26%
1/391 • 80 weeks
|
|
Cardiac disorders
Extrasystoles
|
0.78%
1/129 • 80 weeks
|
0.00%
0/123 • 80 weeks
|
0.00%
0/139 • 80 weeks
|
0.26%
1/391 • 80 weeks
|
|
Eye disorders
Cataract
|
0.78%
1/129 • 80 weeks
|
0.00%
0/123 • 80 weeks
|
0.72%
1/139 • 80 weeks
|
0.51%
2/391 • 80 weeks
|
|
Gastrointestinal disorders
Inguinal hernia strangulated
|
0.00%
0/129 • 80 weeks
|
0.00%
0/123 • 80 weeks
|
0.72%
1/139 • 80 weeks
|
0.26%
1/391 • 80 weeks
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/129 • 80 weeks
|
0.00%
0/123 • 80 weeks
|
0.72%
1/139 • 80 weeks
|
0.26%
1/391 • 80 weeks
|
|
Gastrointestinal disorders
Rectal obstruction
|
0.78%
1/129 • 80 weeks
|
0.00%
0/123 • 80 weeks
|
0.00%
0/139 • 80 weeks
|
0.26%
1/391 • 80 weeks
|
|
General disorders
Asthenia
|
0.78%
1/129 • 80 weeks
|
0.00%
0/123 • 80 weeks
|
0.00%
0/139 • 80 weeks
|
0.26%
1/391 • 80 weeks
|
|
General disorders
Drug withdrawal syndrome
|
0.78%
1/129 • 80 weeks
|
0.00%
0/123 • 80 weeks
|
0.00%
0/139 • 80 weeks
|
0.26%
1/391 • 80 weeks
|
|
General disorders
Multi-organ failure
|
0.00%
0/129 • 80 weeks
|
0.81%
1/123 • 80 weeks
|
0.00%
0/139 • 80 weeks
|
0.26%
1/391 • 80 weeks
|
|
General disorders
Oedema peripheral
|
0.00%
0/129 • 80 weeks
|
0.00%
0/123 • 80 weeks
|
0.72%
1/139 • 80 weeks
|
0.26%
1/391 • 80 weeks
|
|
Infections and infestations
Appendicitis
|
0.00%
0/129 • 80 weeks
|
0.81%
1/123 • 80 weeks
|
0.00%
0/139 • 80 weeks
|
0.26%
1/391 • 80 weeks
|
|
Infections and infestations
Pneumonia
|
0.78%
1/129 • 80 weeks
|
0.81%
1/123 • 80 weeks
|
0.72%
1/139 • 80 weeks
|
0.77%
3/391 • 80 weeks
|
|
Infections and infestations
Sepsis
|
0.00%
0/129 • 80 weeks
|
0.00%
0/123 • 80 weeks
|
0.72%
1/139 • 80 weeks
|
0.26%
1/391 • 80 weeks
|
|
Infections and infestations
Septic shock
|
0.00%
0/129 • 80 weeks
|
0.81%
1/123 • 80 weeks
|
0.00%
0/139 • 80 weeks
|
0.26%
1/391 • 80 weeks
|
|
Infections and infestations
Urosepsis
|
0.00%
0/129 • 80 weeks
|
0.81%
1/123 • 80 weeks
|
0.00%
0/139 • 80 weeks
|
0.26%
1/391 • 80 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
0.78%
1/129 • 80 weeks
|
0.00%
0/123 • 80 weeks
|
0.72%
1/139 • 80 weeks
|
0.51%
2/391 • 80 weeks
|
|
Injury, poisoning and procedural complications
Eyeball rupture
|
0.78%
1/129 • 80 weeks
|
0.00%
0/123 • 80 weeks
|
0.00%
0/139 • 80 weeks
|
0.26%
1/391 • 80 weeks
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/129 • 80 weeks
|
0.00%
0/123 • 80 weeks
|
0.72%
1/139 • 80 weeks
|
0.26%
1/391 • 80 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
2.3%
3/129 • 80 weeks
|
0.00%
0/123 • 80 weeks
|
1.4%
2/139 • 80 weeks
|
1.3%
5/391 • 80 weeks
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.78%
1/129 • 80 weeks
|
0.81%
1/123 • 80 weeks
|
0.00%
0/139 • 80 weeks
|
0.51%
2/391 • 80 weeks
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.78%
1/129 • 80 weeks
|
0.00%
0/123 • 80 weeks
|
0.00%
0/139 • 80 weeks
|
0.26%
1/391 • 80 weeks
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.78%
1/129 • 80 weeks
|
0.00%
0/123 • 80 weeks
|
0.00%
0/139 • 80 weeks
|
0.26%
1/391 • 80 weeks
|
|
Injury, poisoning and procedural complications
Muscle injury
|
0.78%
1/129 • 80 weeks
|
0.00%
0/123 • 80 weeks
|
0.00%
0/139 • 80 weeks
|
0.26%
1/391 • 80 weeks
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/129 • 80 weeks
|
0.00%
0/123 • 80 weeks
|
0.72%
1/139 • 80 weeks
|
0.26%
1/391 • 80 weeks
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/129 • 80 weeks
|
0.00%
0/123 • 80 weeks
|
0.72%
1/139 • 80 weeks
|
0.26%
1/391 • 80 weeks
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.78%
1/129 • 80 weeks
|
0.00%
0/123 • 80 weeks
|
0.00%
0/139 • 80 weeks
|
0.26%
1/391 • 80 weeks
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/129 • 80 weeks
|
0.00%
0/123 • 80 weeks
|
0.72%
1/139 • 80 weeks
|
0.26%
1/391 • 80 weeks
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.78%
1/129 • 80 weeks
|
0.00%
0/123 • 80 weeks
|
0.72%
1/139 • 80 weeks
|
0.51%
2/391 • 80 weeks
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.78%
1/129 • 80 weeks
|
0.00%
0/123 • 80 weeks
|
0.00%
0/139 • 80 weeks
|
0.26%
1/391 • 80 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle rigidity
|
0.78%
1/129 • 80 weeks
|
0.00%
0/123 • 80 weeks
|
0.00%
0/139 • 80 weeks
|
0.26%
1/391 • 80 weeks
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/129 • 80 weeks
|
0.00%
0/123 • 80 weeks
|
0.72%
1/139 • 80 weeks
|
0.26%
1/391 • 80 weeks
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.78%
1/129 • 80 weeks
|
0.00%
0/123 • 80 weeks
|
0.00%
0/139 • 80 weeks
|
0.26%
1/391 • 80 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/129 • 80 weeks
|
0.81%
1/123 • 80 weeks
|
0.00%
0/139 • 80 weeks
|
0.26%
1/391 • 80 weeks
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/129 • 80 weeks
|
0.81%
1/123 • 80 weeks
|
0.00%
0/139 • 80 weeks
|
0.26%
1/391 • 80 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
|
0.78%
1/129 • 80 weeks
|
0.00%
0/123 • 80 weeks
|
0.00%
0/139 • 80 weeks
|
0.26%
1/391 • 80 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal neoplasm
|
0.78%
1/129 • 80 weeks
|
0.00%
0/123 • 80 weeks
|
0.00%
0/139 • 80 weeks
|
0.26%
1/391 • 80 weeks
|
|
Nervous system disorders
Cerebellar haematoma
|
0.00%
0/129 • 80 weeks
|
0.00%
0/123 • 80 weeks
|
0.72%
1/139 • 80 weeks
|
0.26%
1/391 • 80 weeks
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/129 • 80 weeks
|
0.81%
1/123 • 80 weeks
|
0.00%
0/139 • 80 weeks
|
0.26%
1/391 • 80 weeks
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.78%
1/129 • 80 weeks
|
0.00%
0/123 • 80 weeks
|
0.00%
0/139 • 80 weeks
|
0.26%
1/391 • 80 weeks
|
|
Nervous system disorders
Dizziness
|
0.00%
0/129 • 80 weeks
|
0.00%
0/123 • 80 weeks
|
0.72%
1/139 • 80 weeks
|
0.26%
1/391 • 80 weeks
|
|
Nervous system disorders
Dyskinesia
|
0.00%
0/129 • 80 weeks
|
0.81%
1/123 • 80 weeks
|
0.00%
0/139 • 80 weeks
|
0.26%
1/391 • 80 weeks
|
|
Nervous system disorders
Dystonia
|
0.00%
0/129 • 80 weeks
|
0.81%
1/123 • 80 weeks
|
0.00%
0/139 • 80 weeks
|
0.26%
1/391 • 80 weeks
|
|
Nervous system disorders
Hypertensive encephalopathy
|
0.00%
0/129 • 80 weeks
|
0.00%
0/123 • 80 weeks
|
0.72%
1/139 • 80 weeks
|
0.26%
1/391 • 80 weeks
|
|
Nervous system disorders
On and off phenomenon
|
0.00%
0/129 • 80 weeks
|
0.00%
0/123 • 80 weeks
|
0.72%
1/139 • 80 weeks
|
0.26%
1/391 • 80 weeks
|
|
Nervous system disorders
Parkinson's disease
|
0.78%
1/129 • 80 weeks
|
0.00%
0/123 • 80 weeks
|
0.00%
0/139 • 80 weeks
|
0.26%
1/391 • 80 weeks
|
|
Psychiatric disorders
Cardiac neurosis
|
0.00%
0/129 • 80 weeks
|
0.00%
0/123 • 80 weeks
|
0.72%
1/139 • 80 weeks
|
0.26%
1/391 • 80 weeks
|
|
Psychiatric disorders
Depression
|
0.00%
0/129 • 80 weeks
|
0.81%
1/123 • 80 weeks
|
0.00%
0/139 • 80 weeks
|
0.26%
1/391 • 80 weeks
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/129 • 80 weeks
|
0.81%
1/123 • 80 weeks
|
0.00%
0/139 • 80 weeks
|
0.26%
1/391 • 80 weeks
|
|
Psychiatric disorders
Paramnesia
|
0.00%
0/129 • 80 weeks
|
0.81%
1/123 • 80 weeks
|
0.00%
0/139 • 80 weeks
|
0.26%
1/391 • 80 weeks
|
|
Psychiatric disorders
Pathological gambling
|
0.00%
0/129 • 80 weeks
|
0.00%
0/123 • 80 weeks
|
0.72%
1/139 • 80 weeks
|
0.26%
1/391 • 80 weeks
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/129 • 80 weeks
|
0.81%
1/123 • 80 weeks
|
0.00%
0/139 • 80 weeks
|
0.26%
1/391 • 80 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.78%
1/129 • 80 weeks
|
0.00%
0/123 • 80 weeks
|
0.00%
0/139 • 80 weeks
|
0.26%
1/391 • 80 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/129 • 80 weeks
|
0.81%
1/123 • 80 weeks
|
0.00%
0/139 • 80 weeks
|
0.26%
1/391 • 80 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/129 • 80 weeks
|
0.81%
1/123 • 80 weeks
|
0.00%
0/139 • 80 weeks
|
0.26%
1/391 • 80 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/129 • 80 weeks
|
0.00%
0/123 • 80 weeks
|
0.72%
1/139 • 80 weeks
|
0.26%
1/391 • 80 weeks
|
|
Vascular disorders
Aortic stenosis
|
0.78%
1/129 • 80 weeks
|
0.00%
0/123 • 80 weeks
|
0.00%
0/139 • 80 weeks
|
0.26%
1/391 • 80 weeks
|
|
Vascular disorders
Hypotension
|
0.00%
0/129 • 80 weeks
|
0.81%
1/123 • 80 weeks
|
0.00%
0/139 • 80 weeks
|
0.26%
1/391 • 80 weeks
|
Other adverse events
| Measure |
PPX ER (Previous Placebo)
n=129 participants at risk
Pramipexole ER Treatment with placebo in previous trial
|
PPX ER (Previous PPX ER)
n=123 participants at risk
Pramipexole ER Treatment with Pramipexole ER in previous trial
|
PPX ER (Previous PPX IR)
n=139 participants at risk
Pramipexole ER Treatment with Pramipexole IR in previous trial
|
Total PPX ER
n=391 participants at risk
Pramipexole ER, all patients
|
|---|---|---|---|---|
|
Eye disorders
Cataract
|
7.0%
9/129 • 80 weeks
|
6.5%
8/123 • 80 weeks
|
4.3%
6/139 • 80 weeks
|
5.9%
23/391 • 80 weeks
|
|
Gastrointestinal disorders
Constipation
|
6.2%
8/129 • 80 weeks
|
4.1%
5/123 • 80 weeks
|
2.2%
3/139 • 80 weeks
|
4.1%
16/391 • 80 weeks
|
|
Gastrointestinal disorders
Nausea
|
7.8%
10/129 • 80 weeks
|
5.7%
7/123 • 80 weeks
|
5.0%
7/139 • 80 weeks
|
6.1%
24/391 • 80 weeks
|
|
Infections and infestations
Nasopharyngitis
|
2.3%
3/129 • 80 weeks
|
3.3%
4/123 • 80 weeks
|
5.8%
8/139 • 80 weeks
|
3.8%
15/391 • 80 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
6.2%
8/129 • 80 weeks
|
7.3%
9/123 • 80 weeks
|
4.3%
6/139 • 80 weeks
|
5.9%
23/391 • 80 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
3.1%
4/129 • 80 weeks
|
4.1%
5/123 • 80 weeks
|
5.8%
8/139 • 80 weeks
|
4.3%
17/391 • 80 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.4%
7/129 • 80 weeks
|
4.9%
6/123 • 80 weeks
|
4.3%
6/139 • 80 weeks
|
4.9%
19/391 • 80 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.4%
7/129 • 80 weeks
|
5.7%
7/123 • 80 weeks
|
3.6%
5/139 • 80 weeks
|
4.9%
19/391 • 80 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle rigidity
|
0.78%
1/129 • 80 weeks
|
1.6%
2/123 • 80 weeks
|
6.5%
9/139 • 80 weeks
|
3.1%
12/391 • 80 weeks
|
|
Nervous system disorders
Dizziness
|
10.1%
13/129 • 80 weeks
|
8.9%
11/123 • 80 weeks
|
2.9%
4/139 • 80 weeks
|
7.2%
28/391 • 80 weeks
|
|
Nervous system disorders
Dyskinesia
|
31.8%
41/129 • 80 weeks
|
26.8%
33/123 • 80 weeks
|
23.0%
32/139 • 80 weeks
|
27.1%
106/391 • 80 weeks
|
|
Nervous system disorders
Dystonia
|
3.1%
4/129 • 80 weeks
|
6.5%
8/123 • 80 weeks
|
5.0%
7/139 • 80 weeks
|
4.9%
19/391 • 80 weeks
|
|
Nervous system disorders
Headache
|
4.7%
6/129 • 80 weeks
|
4.1%
5/123 • 80 weeks
|
5.8%
8/139 • 80 weeks
|
4.9%
19/391 • 80 weeks
|
|
Nervous system disorders
Somnolence
|
11.6%
15/129 • 80 weeks
|
14.6%
18/123 • 80 weeks
|
13.7%
19/139 • 80 weeks
|
13.3%
52/391 • 80 weeks
|
|
Nervous system disorders
Tremor
|
4.7%
6/129 • 80 weeks
|
3.3%
4/123 • 80 weeks
|
5.8%
8/139 • 80 weeks
|
4.6%
18/391 • 80 weeks
|
|
Psychiatric disorders
Hallucination
|
7.8%
10/129 • 80 weeks
|
4.9%
6/123 • 80 weeks
|
4.3%
6/139 • 80 weeks
|
5.6%
22/391 • 80 weeks
|
|
Psychiatric disorders
Insomnia
|
7.8%
10/129 • 80 weeks
|
8.1%
10/123 • 80 weeks
|
5.0%
7/139 • 80 weeks
|
6.9%
27/391 • 80 weeks
|
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 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