Trial Outcomes & Findings for Study to Investigate Pharmacokinetics (PK) of Pramipexole in Pediatric Patients Who Are Individually Optimized to Stable Pramipexole Doses for the Treatment of Idiopathic Restless Legs Syndrome (RLS) (NCT NCT02231918)
NCT ID: NCT02231918
Last Updated: 2015-10-06
Results Overview
Maximum concentration of the Pramipexole (PPX) in plasma at steady state over a uniform dosing interval (Cmax,ss).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
26 participants
Primary outcome timeframe
0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.
Results posted on
2015-10-06
Participant Flow
Open label, single dose pharmacokinetic study in pediatric patients with a diagnosis of idiopathic Restless Legs Syndrome(RLS). For the dose MIRAPEX(0.5 mg),Only 2 subjects (12 to\<18 years) were recruited and it was not likely that patients for this dose will be fully recruited so the recruitment was stopped and terminated for this dose only.
Participant milestones
| Measure |
PPX (MIRAPEX®, 0.125 mg)
Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
|
PPX (MIRAPEX®, 0.25 mg)
Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
|
PPX (MIRAPEX®, 0.5 mg)
Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
|
|---|---|---|---|
|
Overall Study
STARTED
|
9
|
15
|
2
|
|
Overall Study
COMPLETED
|
9
|
14
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
PPX (MIRAPEX®, 0.125 mg)
Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
|
PPX (MIRAPEX®, 0.25 mg)
Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
|
PPX (MIRAPEX®, 0.5 mg)
Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
Baseline Characteristics
Study to Investigate Pharmacokinetics (PK) of Pramipexole in Pediatric Patients Who Are Individually Optimized to Stable Pramipexole Doses for the Treatment of Idiopathic Restless Legs Syndrome (RLS)
Baseline characteristics by cohort
| Measure |
PPX (MIRAPEX®, 0.125 mg)
n=9 Participants
Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
|
PPX (MIRAPEX®, 0.25 mg)
n=15 Participants
Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
|
PPX (MIRAPEX®, 0.5 mg)
n=2 Participants
Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
10.6 years
STANDARD_DEVIATION 4.3 • n=99 Participants
|
11.4 years
STANDARD_DEVIATION 3.4 • n=107 Participants
|
15.0 years
STANDARD_DEVIATION 0.0 • n=206 Participants
|
11.4 years
STANDARD_DEVIATION 3.7 • n=7 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.Population: Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.
Maximum concentration of the Pramipexole (PPX) in plasma at steady state over a uniform dosing interval (Cmax,ss).
Outcome measures
| Measure |
PPX (MIRAPEX®, 0.125 mg)
n=9 Participants
Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
|
PPX (MIRAPEX®, 0.25 mg)
n=15 Participants
Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
|
PPX (MIRAPEX®, 0.5 mg)
n=2 Participants
Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
|
|---|---|---|---|
|
Cmax,ss
6 to <12 years (N=5, 9, 0)
|
0.633 ng/mL
Geometric Coefficient of Variation 26.2
|
1.13 ng/mL
Geometric Coefficient of Variation 35.3
|
NA ng/mL
Geometric Coefficient of Variation NA
No patients were recruited for this category.
|
|
Cmax,ss
12 to <18 years(N=4, 6, 2))
|
0.396 ng/mL
Geometric Coefficient of Variation 30.0
|
0.677 ng/mL
Geometric Coefficient of Variation 40.3
|
NA ng/mL
Geometric Coefficient of Variation NA
The reliable estimation can only be performed when at least 2/3 of the data are available and thus the geometric mean (gMean) and geometric coefficient of variation (gCV) is not calculated according to internal rules.
|
PRIMARY outcome
Timeframe: 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.Population: Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.
Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval (Cmin,ss).
Outcome measures
| Measure |
PPX (MIRAPEX®, 0.125 mg)
n=9 Participants
Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
|
PPX (MIRAPEX®, 0.25 mg)
n=15 Participants
Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
|
PPX (MIRAPEX®, 0.5 mg)
n=2 Participants
Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
|
|---|---|---|---|
|
Cmin,ss
6 to <12 years (N=5, 9, 0)
|
0.0872 ng/mL
Standard Deviation 35.5
|
0.136 ng/mL
Standard Deviation 99.5
|
NA ng/mL
Standard Deviation NA
No patients were recruited for this category.
|
|
Cmin,ss
12 to <18 years(N=4, 6, 2)
|
0.0972 ng/mL
Standard Deviation 37.5
|
0.122 ng/mL
Standard Deviation 53.8
|
NA ng/mL
Standard Deviation NA
The reliable estimation can only be performed when at least 2/3 of the data are available and thus the gMean and gCV is not calculated according to internal rules.
|
PRIMARY outcome
Timeframe: 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.Population: Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.
Predose concentration of the analyte in plasma at steady state immediately before administration of the next dose N (Cpre,N).
Outcome measures
| Measure |
PPX (MIRAPEX®, 0.125 mg)
n=9 Participants
Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
|
PPX (MIRAPEX®, 0.25 mg)
n=15 Participants
Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
|
PPX (MIRAPEX®, 0.5 mg)
n=2 Participants
Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
|
|---|---|---|---|
|
Cpre,N
6 to <12 years (N=4, 8, 0)
|
0.074 ng/mL
Geometric Coefficient of Variation 17.3
|
0.147 ng/mL
Geometric Coefficient of Variation 75.3
|
NA ng/mL
Geometric Coefficient of Variation NA
No patients were recruited for this category.
|
|
Cpre,N
12 to <18 years (N=1, 5, 1)
|
NA ng/mL
Geometric Coefficient of Variation NA
The reliable estimation can only be performed when at least 2/3 of the data are available and thus the gMean and gCV is not calculated according to internal rules.
|
0.112 ng/mL
Geometric Coefficient of Variation 60.7
|
NA ng/mL
Geometric Coefficient of Variation NA
The reliable estimation can only be performed when at least 2/3 of the data are available and thus the gMean and gCV is not calculated according to internal rules.
|
PRIMARY outcome
Timeframe: 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.Population: Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.
Average concentration of the analyte in plasma at steady state (Cavg).
Outcome measures
| Measure |
PPX (MIRAPEX®, 0.125 mg)
n=9 Participants
Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
|
PPX (MIRAPEX®, 0.25 mg)
n=15 Participants
Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
|
PPX (MIRAPEX®, 0.5 mg)
n=2 Participants
Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
|
|---|---|---|---|
|
Cavg
6 to <12 years (N=5, 8, 0)
|
0.213 ng/mL
Geometric Coefficient of Variation 27.4
|
0.458 ng/mL
Geometric Coefficient of Variation 42.8
|
NA ng/mL
Geometric Coefficient of Variation NA
No patients were recruited for this category.
|
|
Cavg
12 to <18 years (N=4, 6, 1)
|
0.137 ng/mL
Geometric Coefficient of Variation 21.3
|
0.309 ng/mL
Geometric Coefficient of Variation 35.2
|
NA ng/mL
Geometric Coefficient of Variation NA
The reliable estimation can only be performed when at least 2/3 of the data are available and thus the gMean and gCV is not calculated according to internal rules.
|
PRIMARY outcome
Timeframe: 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.Population: Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.
Time from dosing to maximum concentration at steady state (Tmax,ss).
Outcome measures
| Measure |
PPX (MIRAPEX®, 0.125 mg)
n=9 Participants
Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
|
PPX (MIRAPEX®, 0.25 mg)
n=15 Participants
Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
|
PPX (MIRAPEX®, 0.5 mg)
n=2 Participants
Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
|
|---|---|---|---|
|
Tmax,ss
6 to <12 years (N=5, 9, 0)
|
2.00 hours
Interval 1.0 to 2.0
|
2.00 hours
Interval 1.0 to 3.0
|
NA hours
No patients were recruited for this category.
|
|
Tmax,ss
12 to <18 years (N=4, 6, 2)
|
2.00 hours
Interval 0.5 to 2.0
|
1.96 hours
Interval 0.5 to 5.0
|
NA hours
The reliable estimation can only be performed when at least 2/3 of the data are available and thus the median and range are not calculated according to internal rules.
|
PRIMARY outcome
Timeframe: 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.Population: Pharmacokinetic Set (PK): All evaluable subjects who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.
Time from dosing to minimum concentration at steady state (Tmin,ss ).
Outcome measures
| Measure |
PPX (MIRAPEX®, 0.125 mg)
n=9 Participants
Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
|
PPX (MIRAPEX®, 0.25 mg)
n=15 Participants
Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
|
PPX (MIRAPEX®, 0.5 mg)
n=2 Participants
Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
|
|---|---|---|---|
|
Tmin,ss
6 to <12 years (N=5, 9, 0)
|
12.0 hours
Interval 0.5 to 24.0
|
24.0 hours
Interval 0.25 to 24.0
|
NA hours
No patients were recruited for this category.
|
|
Tmin,ss
12 to <18 years (N=4, 6, 2)
|
6.25 hours
Interval 0.5 to 12.0
|
23.9 hours
Interval 0.5 to 24.0
|
NA hours
The reliable estimation can only be performed when at least 2/3 of the data are available and thus the median and range are not calculated according to internal rules.
|
PRIMARY outcome
Timeframe: 0.25h before the drug administration on day 1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on Day 1.Population: Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.
Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval (AUCτ,ss ).
Outcome measures
| Measure |
PPX (MIRAPEX®, 0.125 mg)
n=9 Participants
Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
|
PPX (MIRAPEX®, 0.25 mg)
n=15 Participants
Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
|
PPX (MIRAPEX®, 0.5 mg)
n=2 Participants
Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
|
|---|---|---|---|
|
AUCτ,ss
6 to <12 years (N=5, 8, 0)
|
5.12 ng*h/mL
Geometric Coefficient of Variation 27.4
|
11.0 ng*h/mL
Geometric Coefficient of Variation 42.8
|
NA ng*h/mL
Geometric Coefficient of Variation NA
No patients were recruited for this category.
|
|
AUCτ,ss
12 to <18 years (N=4, 6, 1)
|
3.28 ng*h/mL
Geometric Coefficient of Variation 21.3
|
7.42 ng*h/mL
Geometric Coefficient of Variation 35.2
|
NA ng*h/mL
Geometric Coefficient of Variation NA
The reliable estimation can only be performed when at least 2/3 of the data are available and thus the gMean and gCV is not calculated according to internal rules.
|
PRIMARY outcome
Timeframe: 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.Population: Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.
Terminal rate constant in plasma at steady state (λz,ss ).
Outcome measures
| Measure |
PPX (MIRAPEX®, 0.125 mg)
n=9 Participants
Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
|
PPX (MIRAPEX®, 0.25 mg)
n=15 Participants
Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
|
PPX (MIRAPEX®, 0.5 mg)
n=2 Participants
Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
|
|---|---|---|---|
|
λz,ss
6 to <12 years (N=5, 8, 0)
|
0.132 1/h
Geometric Coefficient of Variation 22.6
|
0.107 1/h
Geometric Coefficient of Variation 20.1
|
NA 1/h
Geometric Coefficient of Variation NA
No patients were recruited for this category.
|
|
λz,ss
12 to <18 years (N=4, 6, 1)
|
0.113 1/h
Geometric Coefficient of Variation 1.88
|
0.0938 1/h
Geometric Coefficient of Variation 25.4
|
NA 1/h
Geometric Coefficient of Variation NA
The reliable estimation can only be performed when at least 2/3 of the data are available and thus the gMean and gCV is not calculated according to internal rules.
|
PRIMARY outcome
Timeframe: 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.Population: Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.
Terminal half-life of the analyte in plasma at steady state (t1/2,ss ).
Outcome measures
| Measure |
PPX (MIRAPEX®, 0.125 mg)
n=9 Participants
Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
|
PPX (MIRAPEX®, 0.25 mg)
n=15 Participants
Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
|
PPX (MIRAPEX®, 0.5 mg)
n=2 Participants
Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
|
|---|---|---|---|
|
t1/2,ss
6 to <12 years (N=5, 8, 0)
|
5.26 hours
Geometric Coefficient of Variation 22.6
|
6.50 hours
Geometric Coefficient of Variation 20.1
|
NA hours
Geometric Coefficient of Variation NA
No patients were recruited for this category.
|
|
t1/2,ss
12 to <18 years (N=4, 6, 1)
|
6.13 hours
Geometric Coefficient of Variation 1.88
|
7.39 hours
Geometric Coefficient of Variation 25.4
|
NA hours
Geometric Coefficient of Variation NA
The reliable estimation can only be performed when at least 2/3 of the data are available and thus the gMean and gCV is not calculated according to internal rules.
|
PRIMARY outcome
Timeframe: 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.Population: Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.
Mean residence time of the analyte in the body at steady state (MRTpo,ss).
Outcome measures
| Measure |
PPX (MIRAPEX®, 0.125 mg)
n=9 Participants
Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
|
PPX (MIRAPEX®, 0.25 mg)
n=15 Participants
Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
|
PPX (MIRAPEX®, 0.5 mg)
n=2 Participants
Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
|
|---|---|---|---|
|
MRTpo,ss
6 to <12 years (N=5, 8, 0)
|
8.19 h
Geometric Coefficient of Variation 13.1
|
10.1 h
Geometric Coefficient of Variation 19.5
|
NA h
Geometric Coefficient of Variation NA
No patients were recruited for this category.
|
|
MRTpo,ss
12 to <18 years (N=4, 6, 1)
|
9.47 h
Geometric Coefficient of Variation 5.30
|
11.6 h
Geometric Coefficient of Variation 23.3
|
NA h
Geometric Coefficient of Variation NA
The reliable estimation can only be performed when at least 2/3 of the data are available and thus the gMean and gCV is not calculated according to internal rules.
|
PRIMARY outcome
Timeframe: 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.Population: Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.
Apparent clearance of the analyte in the plasma after extravascular administration at steady state; F = absolute bioavailability factor (CL/F,ss ).
Outcome measures
| Measure |
PPX (MIRAPEX®, 0.125 mg)
n=9 Participants
Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
|
PPX (MIRAPEX®, 0.25 mg)
n=15 Participants
Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
|
PPX (MIRAPEX®, 0.5 mg)
n=2 Participants
Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
|
|---|---|---|---|
|
CL/F,ss
6 to <12 years (N=5, 8, 0)
|
284 mL/min
Geometric Coefficient of Variation 27.4
|
265 mL/min
Geometric Coefficient of Variation 42.8
|
NA mL/min
Geometric Coefficient of Variation NA
No patients were recruited for this category.
|
|
CL/F,ss
12 to <18 years (N=4, 6, 1)
|
444 mL/min
Geometric Coefficient of Variation 21.3
|
393 mL/min
Geometric Coefficient of Variation 35.2
|
NA mL/min
Geometric Coefficient of Variation NA
The reliable estimation can only be performed when at least 2/3 of the data are available and thus the gMean and gCV is not calculated according to internal rules.
|
PRIMARY outcome
Timeframe: 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.Population: Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.
Apparent volume of distribution during the terminal phase λz following an extravascular dose at steady state (Vz/F,ss ).
Outcome measures
| Measure |
PPX (MIRAPEX®, 0.125 mg)
n=9 Participants
Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
|
PPX (MIRAPEX®, 0.25 mg)
n=15 Participants
Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
|
PPX (MIRAPEX®, 0.5 mg)
n=2 Participants
Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
|
|---|---|---|---|
|
Vz/F,ss
6 to <12 years (N=5, 8, 0)
|
129 L
Geometric Coefficient of Variation 12.3
|
149 L
Geometric Coefficient of Variation 29.7
|
NA L
Geometric Coefficient of Variation NA
No patients were recruited for this category.
|
|
Vz/F,ss
12 to <18 years (N=4, 6,1)
|
236 L
Geometric Coefficient of Variation 19.4
|
251 L
Geometric Coefficient of Variation 37.3
|
NA L
Geometric Coefficient of Variation NA
The reliable estimation can only be performed when at least 2/3 of the data are available and thus the gMean and gCV is not calculated according to internal rules.
|
PRIMARY outcome
Timeframe: 12 hours after last study drug administration on day 1Population: Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.
Amount of analyte that is eliminated in urine at steady state over a time interval t1to t2 (0-12h).
Outcome measures
| Measure |
PPX (MIRAPEX®, 0.125 mg)
n=9 Participants
Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
|
PPX (MIRAPEX®, 0.25 mg)
n=15 Participants
Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
|
PPX (MIRAPEX®, 0.5 mg)
n=2 Participants
Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
|
|---|---|---|---|
|
Ae 0-12,ss
6 to <12 years (N=4, 6, 0)
|
50600 ng
Geometric Coefficient of Variation 14.6
|
123000 ng
Geometric Coefficient of Variation 50.7
|
NA ng
Geometric Coefficient of Variation NA
No patients were recruited for this category.
|
|
Ae 0-12,ss
12 to <18 years (N=3, 6, 0)
|
55200 ng
Geometric Coefficient of Variation 41.5
|
82300 ng
Geometric Coefficient of Variation 52.7
|
NA ng
Geometric Coefficient of Variation NA
No data was available of any patients for this category, so there was no data to analyse.
|
PRIMARY outcome
Timeframe: 12 hours after last study drug administration on day 1.Population: Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.
Fraction of administered drug excreted unchanged in urine at steady state over a time interval t1 to t2 (fe 0-12,ss ).
Outcome measures
| Measure |
PPX (MIRAPEX®, 0.125 mg)
n=9 Participants
Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
|
PPX (MIRAPEX®, 0.25 mg)
n=15 Participants
Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
|
PPX (MIRAPEX®, 0.5 mg)
n=2 Participants
Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
|
|---|---|---|---|
|
fe 0-12,ss
12 to <18 years (N=2, 5, 0)
|
NA % of PPX excreted
Geometric Coefficient of Variation NA
The reliable estimation can only be performed when at least 2/3 of the data are available and thus the gMean and gCV is not calculated according to internal rules.
|
42.0 % of PPX excreted
Geometric Coefficient of Variation 48.1
|
NA % of PPX excreted
Geometric Coefficient of Variation NA
No data was available of any patients for this category, so there was no data to analyse.
|
|
fe 0-12,ss
6 to <12 years (N=4, 2, 0)
|
58.0 % of PPX excreted
Geometric Coefficient of Variation 14.6
|
NA % of PPX excreted
Geometric Coefficient of Variation NA
The reliable estimation can only be performed when at least 2/3 of the data are available and thus the gMean and gCV is not calculated according to internal rules.
|
NA % of PPX excreted
Geometric Coefficient of Variation NA
No patients were recruited for this category.
|
PRIMARY outcome
Timeframe: 12h after last study drug administration on day 1Population: Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.
Renal clearance of the analyte at steady state (CLR(0-12),ss ).
Outcome measures
| Measure |
PPX (MIRAPEX®, 0.125 mg)
n=9 Participants
Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
|
PPX (MIRAPEX®, 0.25 mg)
n=15 Participants
Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
|
PPX (MIRAPEX®, 0.5 mg)
n=2 Participants
Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
|
|---|---|---|---|
|
CLR,ss
6 to <12 years (N=4, 2, 0)
|
201 mL/min
Geometric Coefficient of Variation 34.1
|
NA mL/min
Geometric Coefficient of Variation NA
The reliable estimation can only be performed when at least 2/3 of the data are available and thus the gMean and gCV is not calculated according to internal rules.
|
NA mL/min
Geometric Coefficient of Variation NA
No subjects were recruited for this category.
|
|
CLR,ss
12 to <18 years (N=2, 5, 0)
|
NA mL/min
Geometric Coefficient of Variation NA
The reliable estimation can only be performed when at least 2/3 of the data are available and thus the gMean and gCV is not calculated according to internal rules.
|
253 mL/min
Geometric Coefficient of Variation 34.1
|
NA mL/min
Geometric Coefficient of Variation NA
No data was available of any patients for this category, so there was no data to analyse.
|
PRIMARY outcome
Timeframe: 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.Population: Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.
Peak-trough fluctuation (PTF) is defined as the difference between Cmax and Cmin divided by Cavg and multiplied with 100% at steady-state.
Outcome measures
| Measure |
PPX (MIRAPEX®, 0.125 mg)
n=9 Participants
Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
|
PPX (MIRAPEX®, 0.25 mg)
n=15 Participants
Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
|
PPX (MIRAPEX®, 0.5 mg)
n=2 Participants
Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
|
|---|---|---|---|
|
PTF
6 to <12 years (N=5, 8, 0)
|
250 % of PTF
Geometric Coefficient of Variation 10.1
|
209 % of PTF
Geometric Coefficient of Variation 31.8
|
NA % of PTF
Geometric Coefficient of Variation NA
No subjects were recruited for this category.
|
|
PTF
12 to <18 years (N=4, 6, 1)
|
216 % of PTF
Geometric Coefficient of Variation 24.0
|
168 % of PTF
Geometric Coefficient of Variation 34.2
|
NA % of PTF
Geometric Coefficient of Variation NA
The reliable estimation can only be performed when at least 2/3 of the data are available and thus the gMean and gCV is not calculated according to internal rules.
|
SECONDARY outcome
Timeframe: From first drug administration until 24 hours after last study drug administration, upto 48 daysPopulation: Safety analysis set: The safety population comprised all patients who provided informed consent and received at least one dose of study drug.
Number of patients with adverse events due to study drug.
Outcome measures
| Measure |
PPX (MIRAPEX®, 0.125 mg)
n=9 Participants
Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
|
PPX (MIRAPEX®, 0.25 mg)
n=15 Participants
Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
|
PPX (MIRAPEX®, 0.5 mg)
n=2 Participants
Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
|
|---|---|---|---|
|
Number of Patients With Drug Related Adverse Events
|
1 participants
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: -0:15h(hours) pre-dose, and 0:30h, 1:00h, 2:00h, 3:00h, 5:00h, 7:00h, 12:00h, 24:00h post-dose.Population: Safety analysis set: The safety population comprised all patients who provided informed consent and received at least one dose of study drug.
Vital signs (Systolic and diastolic blood pressure (both supine and after standing for 1 minute)).
Outcome measures
| Measure |
PPX (MIRAPEX®, 0.125 mg)
n=9 Participants
Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
|
PPX (MIRAPEX®, 0.25 mg)
n=15 Participants
Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
|
PPX (MIRAPEX®, 0.5 mg)
n=2 Participants
Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
|
|---|---|---|---|
|
Vital Signs (Systolic and Diastolic Blood Pressure)
Systolic blood pressure-supine(N= 9,15,2): -0:15h
|
109.33 mmHg
Standard Deviation 6.76
|
109.20 mmHg
Standard Deviation 10.80
|
117.00 mmHg
Standard Deviation 4.24
|
|
Vital Signs (Systolic and Diastolic Blood Pressure)
Systolic blood pressure-supine(N= 9,15,2): 0:30h
|
112.89 mmHg
Standard Deviation 13.90
|
110.33 mmHg
Standard Deviation 14.07
|
116.00 mmHg
Standard Deviation 4.24
|
|
Vital Signs (Systolic and Diastolic Blood Pressure)
Systolic blood pressure-supine(N= 9,15,2): 1:00h
|
113.00 mmHg
Standard Deviation 11.07
|
108.07 mmHg
Standard Deviation 12.92
|
105.50 mmHg
Standard Deviation 0.71
|
|
Vital Signs (Systolic and Diastolic Blood Pressure)
Systolic blood pressure-supine(N= 9,15,2): 2:00h
|
111.00 mmHg
Standard Deviation 7.43
|
111.93 mmHg
Standard Deviation 13.79
|
113.00 mmHg
Standard Deviation 9.90
|
|
Vital Signs (Systolic and Diastolic Blood Pressure)
Systolic blood pressure-supine(N= 9,15,1): 3:00h
|
106.89 mmHg
Standard Deviation 10.40
|
110.53 mmHg
Standard Deviation 11.34
|
113.00 mmHg
Standard Deviation NA
The data of only one patient is available and thus Standard Deviation is not calculable.
|
|
Vital Signs (Systolic and Diastolic Blood Pressure)
Systolic blood pressure-supine(N= 9,15,1): 5:00h
|
105.11 mmHg
Standard Deviation 12.71
|
108.80 mmHg
Standard Deviation 14.89
|
104.00 mmHg
Standard Deviation NA
The data of only one patient is available and thus Standard Deviation is not calculable.
|
|
Vital Signs (Systolic and Diastolic Blood Pressure)
Systolic blood pressure-supine(N= 9,14,1): 7:00h
|
108.44 mmHg
Standard Deviation 12.27
|
109.86 mmHg
Standard Deviation 14.11
|
108.00 mmHg
Standard Deviation NA
The data of only one patient is available and thus Standard Deviation is not calculable.
|
|
Vital Signs (Systolic and Diastolic Blood Pressure)
Systolic blood pressure-supine(N= 9,14,1): 12:00h
|
107.56 mmHg
Standard Deviation 16.38
|
106.93 mmHg
Standard Deviation 16.28
|
109.00 mmHg
Standard Deviation NA
The data of only one patient is available and thus Standard Deviation is not calculable.
|
|
Vital Signs (Systolic and Diastolic Blood Pressure)
Systolic blood pressure-supine(N= 9,14,1): 24:00h
|
109.22 mmHg
Standard Deviation 11.38
|
112.21 mmHg
Standard Deviation 13.76
|
120.00 mmHg
Standard Deviation NA
The data of only one patient is available and thus Standard Deviation is not calculable.
|
|
Vital Signs (Systolic and Diastolic Blood Pressure)
Diastolic blood pressure-supine(N= 9,15,2): -0:15
|
66.67 mmHg
Standard Deviation 7.35
|
65.73 mmHg
Standard Deviation 10.19
|
76.00 mmHg
Standard Deviation 0.00
|
|
Vital Signs (Systolic and Diastolic Blood Pressure)
Diastolic blood pressure-supine(N= 9,15,2): 0:30
|
68.67 mmHg
Standard Deviation 8.93
|
65.80 mmHg
Standard Deviation 12.62
|
73.00 mmHg
Standard Deviation 2.83
|
|
Vital Signs (Systolic and Diastolic Blood Pressure)
Diastolic blood pressure-supine(N= 9,15,2): 1:00
|
69.33 mmHg
Standard Deviation 6.52
|
65.73 mmHg
Standard Deviation 7.80
|
64.00 mmHg
Standard Deviation 12.73
|
|
Vital Signs (Systolic and Diastolic Blood Pressure)
Diastolic blood pressure-supine(N= 9,15,2): 2:00
|
66.00 mmHg
Standard Deviation 8.23
|
65.80 mmHg
Standard Deviation 8.76
|
75.00 mmHg
Standard Deviation 8.49
|
|
Vital Signs (Systolic and Diastolic Blood Pressure)
Diastolic blood pressure-supine(N= 9,15,1): 3:00
|
66.78 mmHg
Standard Deviation 9.36
|
65.40 mmHg
Standard Deviation 9.96
|
75.00 mmHg
Standard Deviation NA
The data of only one patient is available and thus Standard Deviation is not calculable.
|
|
Vital Signs (Systolic and Diastolic Blood Pressure)
Diastolic blood pressure-supine(N= 9,15,1): 5:00
|
64.22 mmHg
Standard Deviation 9.83
|
63.87 mmHg
Standard Deviation 9.78
|
70.00 mmHg
Standard Deviation NA
The data of only one patient is available and thus Standard Deviation is not calculable.
|
|
Vital Signs (Systolic and Diastolic Blood Pressure)
Diastolic blood pressure-supine(N= 9,14,1): 7:00
|
67.56 mmHg
Standard Deviation 13.47
|
62.43 mmHg
Standard Deviation 8.08
|
67.00 mmHg
Standard Deviation NA
The data of only one patient is available and thus Standard Deviation is not calculable.
|
|
Vital Signs (Systolic and Diastolic Blood Pressure)
Diastolic blood pressure-supine(N= 9,14,1): 12:00
|
70.00 mmHg
Standard Deviation 12.03
|
61.00 mmHg
Standard Deviation 9.12
|
66.00 mmHg
Standard Deviation NA
The data of only one patient is available and thus Standard Deviation is not calculable.
|
|
Vital Signs (Systolic and Diastolic Blood Pressure)
Diastolic blood pressure-supine(N= 9,14,1): 24:00
|
66.56 mmHg
Standard Deviation 6.00
|
65.71 mmHg
Standard Deviation 7.61
|
78.00 mmHg
Standard Deviation NA
The data of only one patient is available and thus Standard Deviation is not calculable.
|
|
Vital Signs (Systolic and Diastolic Blood Pressure)
Systolic blood pressure-standing(N= 9,15,2):-0:15h
|
109.89 mmHg
Standard Deviation 8.57
|
113.93 mmHg
Standard Deviation 9.97
|
122.00 mmHg
Standard Deviation 9.90
|
|
Vital Signs (Systolic and Diastolic Blood Pressure)
Systolic blood pressure-standing(N= 9,15,2): 0:30h
|
113.56 mmHg
Standard Deviation 13.62
|
113.67 mmHg
Standard Deviation 13.69
|
115.50 mmHg
Standard Deviation 6.36
|
|
Vital Signs (Systolic and Diastolic Blood Pressure)
Systolic blood pressure-standing(N= 9,15,2): 1:00h
|
110.11 mmHg
Standard Deviation 13.81
|
110.07 mmHg
Standard Deviation 14.26
|
125.50 mmHg
Standard Deviation 23.33
|
|
Vital Signs (Systolic and Diastolic Blood Pressure)
Systolic blood pressure-standing(N= 9,15,2): 2:00h
|
110.33 mmHg
Standard Deviation 8.76
|
112.27 mmHg
Standard Deviation 12.26
|
115.00 mmHg
Standard Deviation 2.83
|
|
Vital Signs (Systolic and Diastolic Blood Pressure)
Systolic blood pressure-standing(N= 9,15,1): 3:00h
|
110.11 mmHg
Standard Deviation 16.50
|
113.07 mmHg
Standard Deviation 16.15
|
108.00 mmHg
Standard Deviation NA
The data of only one patient is available and thus Standard Deviation is not calculable.
|
|
Vital Signs (Systolic and Diastolic Blood Pressure)
Systolic blood pressure-standing(N= 9,14,1): 5:00h
|
110.22 mmHg
Standard Deviation 11.88
|
111.93 mmHg
Standard Deviation 14.91
|
115.00 mmHg
Standard Deviation NA
The data of only one patient is available and thus Standard Deviation is not calculable.
|
|
Vital Signs (Systolic and Diastolic Blood Pressure)
Systolic blood pressure-standing(N= 9,13,1): 7:00h
|
109.11 mmHg
Standard Deviation 11.76
|
103.85 mmHg
Standard Deviation 17.56
|
65.00 mmHg
Standard Deviation NA
The data of only one patient is available and thus Standard Deviation is not calculable.
|
|
Vital Signs (Systolic and Diastolic Blood Pressure)
Systolic blood pressure-standing(N=9,14,1): 12:00h
|
108.22 mmHg
Standard Deviation 9.59
|
107.14 mmHg
Standard Deviation 15.83
|
100.00 mmHg
Standard Deviation NA
The data of only one patient is available and thus Standard Deviation is not calculable.
|
|
Vital Signs (Systolic and Diastolic Blood Pressure)
Systolic blood pressure-standing(N=9,14,1): 24:00h
|
113.89 mmHg
Standard Deviation 11.25
|
115.50 mmHg
Standard Deviation 14.43
|
102.00 mmHg
Standard Deviation NA
The data of only one patient is available and thus Standard Deviation is not calculable.
|
|
Vital Signs (Systolic and Diastolic Blood Pressure)
Diastolicblood pressure-standing(N=9,15,2): -0:15h
|
68.11 mmHg
Standard Deviation 11.87
|
71.20 mmHg
Standard Deviation 8.09
|
86.00 mmHg
Standard Deviation 0.00
|
|
Vital Signs (Systolic and Diastolic Blood Pressure)
Diastolic blood pressure-standing(N=9,15,2): 0:30h
|
70.11 mmHg
Standard Deviation 7.44
|
69.20 mmHg
Standard Deviation 12.11
|
80.00 mmHg
Standard Deviation 1.41
|
|
Vital Signs (Systolic and Diastolic Blood Pressure)
Diastolic blood pressure-standing(N=9,15,2): 1:00h
|
69.22 mmHg
Standard Deviation 6.36
|
72.00 mmHg
Standard Deviation 9.54
|
91.00 mmHg
Standard Deviation 7.07
|
|
Vital Signs (Systolic and Diastolic Blood Pressure)
Diastolic blood pressure-standing(N=9,15,2): 2:00h
|
71.11 mmHg
Standard Deviation 8.82
|
73.13 mmHg
Standard Deviation 9.36
|
86.50 mmHg
Standard Deviation 3.54
|
|
Vital Signs (Systolic and Diastolic Blood Pressure)
Diastolic blood pressure-standing(N=9,15,1): 3:00h
|
72.67 mmHg
Standard Deviation 5.94
|
71.47 mmHg
Standard Deviation 8.98
|
79.00 mmHg
Standard Deviation NA
The data of only one patient is available and thus Standard Deviation is not calculable.
|
|
Vital Signs (Systolic and Diastolic Blood Pressure)
Diastolic blood pressure-standing(N=9,14,1): 5:00h
|
74.00 mmHg
Standard Deviation 10.82
|
70.57 mmHg
Standard Deviation 9.20
|
98.00 mmHg
Standard Deviation NA
The data of only one patient is available and thus Standard Deviation is not calculable.
|
|
Vital Signs (Systolic and Diastolic Blood Pressure)
Diastolic blood pressure-standing(N=9,13,1):7:00h
|
72.00 mmHg
Standard Deviation 13.01
|
66.69 mmHg
Standard Deviation 10.90
|
48.00 mmHg
Standard Deviation NA
The data of only one patient is available and thus Standard Deviation is not calculable.
|
|
Vital Signs (Systolic and Diastolic Blood Pressure)
Diastolic blood pressure-standing(N=9,14,1):12:00h
|
74.33 mmHg
Standard Deviation 11.19
|
70.07 mmHg
Standard Deviation 10.51
|
62.00 mmHg
Standard Deviation NA
The data of only one patient is available and thus Standard Deviation is not calculable.
|
|
Vital Signs (Systolic and Diastolic Blood Pressure)
Diastolicblood pressure-standing(N=9,14,1):24:00h
|
73.11 mmHg
Standard Deviation 8.13
|
73.57 mmHg
Standard Deviation 9.62
|
84.00 mmHg
Standard Deviation NA
The data of only one patient is available and thus Standard Deviation is not calculable.
|
SECONDARY outcome
Timeframe: -0:15h(hours) pre-dose, and 0:30h, 1:00h, 2:00h, 3:00h, 5:00h, 7:00h, 12:00h, 24:00hPopulation: Safety analysis set
Vital signs (Pulse rate (both supine and after standing for 1 minute)).
Outcome measures
| Measure |
PPX (MIRAPEX®, 0.125 mg)
n=9 Participants
Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
|
PPX (MIRAPEX®, 0.25 mg)
n=15 Participants
Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
|
PPX (MIRAPEX®, 0.5 mg)
n=2 Participants
Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
|
|---|---|---|---|
|
Vital Signs (Pulse Rate)
Pulse rate-supine(N=9,15,2): -0:15h
|
82.4 bpm
Standard Deviation 18.6
|
73.3 bpm
Standard Deviation 6.8
|
75.5 bpm
Standard Deviation 24.7
|
|
Vital Signs (Pulse Rate)
Pulse rate-supine(N=9,15,2): 0:30h
|
76.7 bpm
Standard Deviation 17.5
|
78.0 bpm
Standard Deviation 11.7
|
92.0 bpm
Standard Deviation 32.5
|
|
Vital Signs (Pulse Rate)
Pulse rate-supine(N=9,15,2): 1:00h
|
82.7 bpm
Standard Deviation 22.2
|
75.2 bpm
Standard Deviation 6.8
|
87.0 bpm
Standard Deviation 36.8
|
|
Vital Signs (Pulse Rate)
Pulse rate-supine(N=9,15,2): 2:00h
|
85.4 bpm
Standard Deviation 19.6
|
77.9 bpm
Standard Deviation 8.0
|
94.5 bpm
Standard Deviation 26.2
|
|
Vital Signs (Pulse Rate)
Pulse rate-supine(N=9,15,1): 3:00h
|
89.3 bpm
Standard Deviation 19.1
|
79.9 bpm
Standard Deviation 13.6
|
72.0 bpm
Standard Deviation NA
The data of only one patient is available and thus Standard Deviation is not calculable.
|
|
Vital Signs (Pulse Rate)
Pulse rate-supine(N=9,15,1): 5:00h
|
82.7 bpm
Standard Deviation 16.0
|
75.9 bpm
Standard Deviation 6.9
|
77.0 bpm
Standard Deviation NA
The data of only one patient is available and thus Standard Deviation is not calculable.
|
|
Vital Signs (Pulse Rate)
Pulse rate-supine(N=9,14,1): 7:00h
|
88.1 bpm
Standard Deviation 18.1
|
72.0 bpm
Standard Deviation 9.0
|
78.0 bpm
Standard Deviation NA
The data of only one patient is available and thus Standard Deviation is not calculable.
|
|
Vital Signs (Pulse Rate)
Pulse rate-supine(N=9,14,1): 12:00h
|
77.8 bpm
Standard Deviation 15.2
|
68.6 bpm
Standard Deviation 6.2
|
69.0 bpm
Standard Deviation NA
The data of only one patient is available and thus Standard Deviation is not calculable.
|
|
Vital Signs (Pulse Rate)
Pulse rate-supine(N=9,14,1): 24:00h
|
77.9 bpm
Standard Deviation 13.6
|
77.6 bpm
Standard Deviation 8.5
|
77.0 bpm
Standard Deviation NA
The data of only one patient is available and thus Standard Deviation is not calculable.
|
|
Vital Signs (Pulse Rate)
Pulse rate- standing(N=9,15,2):-0:15h
|
90.8 bpm
Standard Deviation 18.3
|
79.4 bpm
Standard Deviation 8.7
|
99.0 bpm
Standard Deviation 22.6
|
|
Vital Signs (Pulse Rate)
Pulse rate- standing(N=9,15,2): 0:30h
|
84.7 bpm
Standard Deviation 15.5
|
81.5 bpm
Standard Deviation 12.2
|
103 bpm
Standard Deviation 27.6
|
|
Vital Signs (Pulse Rate)
Pulse rate- standing(N=9,15,2): 1:00h
|
94.8 bpm
Standard Deviation 20.3
|
85.4 bpm
Standard Deviation 10.9
|
123 bpm
Standard Deviation 43.1
|
|
Vital Signs (Pulse Rate)
Pulse rate- standing (N=9,15,2): 2:00h
|
92.8 bpm
Standard Deviation 17.0
|
89.3 bpm
Standard Deviation 11.2
|
121 bpm
Standard Deviation 1.4
|
|
Vital Signs (Pulse Rate)
Pulse rate- standing (N=9,15,1): 3:00h
|
99.0 bpm
Standard Deviation 18.2
|
92.7 bpm
Standard Deviation 12.9
|
109 bpm
Standard Deviation NA
The data of only one patient is available and thus Standard Deviation is not calculable.
|
|
Vital Signs (Pulse Rate)
Pulse rate- standing (N=9,14,1): 5:00h
|
99.3 bpm
Standard Deviation 27.0
|
87.1 bpm
Standard Deviation 11.4
|
76.0 bpm
Standard Deviation NA
The data of only one patient is available and thus Standard Deviation is not calculable.
|
|
Vital Signs (Pulse Rate)
Pulse rate- standing (N=9,13,1): 7:00h
|
100 bpm
Standard Deviation 17.0
|
82.1 bpm
Standard Deviation 14.4
|
72.0 bpm
Standard Deviation NA
The data of only one patient is available and thus Standard Deviation is not calculable.
|
|
Vital Signs (Pulse Rate)
Pulse rate- standing (N=9,14,1): 12:00h
|
97.8 bpm
Standard Deviation 12.4
|
81.2 bpm
Standard Deviation 12.3
|
86.0 bpm
Standard Deviation NA
The data of only one patient is available and thus Standard Deviation is not calculable.
|
|
Vital Signs (Pulse Rate)
Pulse rate- standing (N=9,14,1): 24:00h
|
90.0 bpm
Standard Deviation 18.8
|
85.8 bpm
Standard Deviation 6.7
|
86.0 bpm
Standard Deviation NA
The data of only one patient is available and thus Standard Deviation is not calculable.
|
Adverse Events
MIRAPEX® (0.125 mg)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
MIRAPEX® (0.25 mg)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
MIRAPEX® (0.5 mg)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
MIRAPEX® (0.125 mg)
n=9 participants at risk
Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
|
MIRAPEX® (0.25 mg)
n=15 participants at risk
Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
|
MIRAPEX® (0.5 mg)
n=2 participants at risk
Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/9 • From first drug administration until 24 hours after last study drug administration, upto 48 days
|
0.00%
0/15 • From first drug administration until 24 hours after last study drug administration, upto 48 days
|
50.0%
1/2 • From first drug administration until 24 hours after last study drug administration, upto 48 days
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/9 • From first drug administration until 24 hours after last study drug administration, upto 48 days
|
6.7%
1/15 • From first drug administration until 24 hours after last study drug administration, upto 48 days
|
50.0%
1/2 • From first drug administration until 24 hours after last study drug administration, upto 48 days
|
|
General disorders
Fatigue
|
11.1%
1/9 • From first drug administration until 24 hours after last study drug administration, upto 48 days
|
0.00%
0/15 • From first drug administration until 24 hours after last study drug administration, upto 48 days
|
0.00%
0/2 • From first drug administration until 24 hours after last study drug administration, upto 48 days
|
|
General disorders
Infusion site erythema
|
0.00%
0/9 • From first drug administration until 24 hours after last study drug administration, upto 48 days
|
6.7%
1/15 • From first drug administration until 24 hours after last study drug administration, upto 48 days
|
0.00%
0/2 • From first drug administration until 24 hours after last study drug administration, upto 48 days
|
|
General disorders
Infusion site irritation
|
0.00%
0/9 • From first drug administration until 24 hours after last study drug administration, upto 48 days
|
6.7%
1/15 • From first drug administration until 24 hours after last study drug administration, upto 48 days
|
0.00%
0/2 • From first drug administration until 24 hours after last study drug administration, upto 48 days
|
|
General disorders
Infusion site pain
|
0.00%
0/9 • From first drug administration until 24 hours after last study drug administration, upto 48 days
|
6.7%
1/15 • From first drug administration until 24 hours after last study drug administration, upto 48 days
|
0.00%
0/2 • From first drug administration until 24 hours after last study drug administration, upto 48 days
|
|
General disorders
Vessel puncture site erythema
|
0.00%
0/9 • From first drug administration until 24 hours after last study drug administration, upto 48 days
|
6.7%
1/15 • From first drug administration until 24 hours after last study drug administration, upto 48 days
|
0.00%
0/2 • From first drug administration until 24 hours after last study drug administration, upto 48 days
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/9 • From first drug administration until 24 hours after last study drug administration, upto 48 days
|
6.7%
1/15 • From first drug administration until 24 hours after last study drug administration, upto 48 days
|
0.00%
0/2 • From first drug administration until 24 hours after last study drug administration, upto 48 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.1%
1/9 • From first drug administration until 24 hours after last study drug administration, upto 48 days
|
0.00%
0/15 • From first drug administration until 24 hours after last study drug administration, upto 48 days
|
0.00%
0/2 • From first drug administration until 24 hours after last study drug administration, upto 48 days
|
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 Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER