Clinical Trial Results:
An open-label clinical study to investigate pharmacokinetics (PK) of different doses (0.125 mg, 0.25 mg, 0.5 mg) of pramipexole administered once daily orally in pediatric patients who are individually optimized to stable pramipexole doses for the treatment of idiopathic Restless Legs Syndrome (RLS).

Due to a system error, the data reported in v1 is not correct and has been removed from public view.

Summary
EudraCT number	2011-002774-23
Trial protocol	Outside EU/EEA
Global end of trial date	03 Jul 2007

Results information
Results version number	v2(current)
This version publication date	02 Jul 2016
First version publication date	01 Aug 2015
Other versions	v1 (removed from public view)
Version creation reason	Correction of full data set Data correction due to system error in EudraCT

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

Collapse all Expand all

Trial information

Top of page

Sponsor protocol code

248.600

ISRCTN number

US NCT number

NCT02231918

WHO universal trial number (UTN)

Sponsor organisation name

Boehringer Ingelheim

Sponsor organisation address

173 Binger Strasse, Ingelheim am Rhein, Germany, 55216

Public contact

QRPE Processes and Systems Coordination Clinical Trial Information Disclosure, Boehringer Ingelheim, +1 8002430127, clintriage.rdg@boehringer-ingelheim.com

Scientific contact

QRPE Processes and Systems Coordination Clinical Trial Information Disclosure, Boehringer Ingelheim, +1 8002430127, clintriage.rdg@boehringer-ingelheim.com

Is trial part of an agreed paediatric investigation plan (PIP)

Yes

EMA paediatric investigation plan number(s)

EMEA-000041-PIP01-07

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Yes

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

11 Sep 2007

Is this the analysis of the primary completion data?

Yes

Primary completion date

03 Jul 2007

Global end of trial reached?

Yes

Global end of trial date

03 Jul 2007

Was the trial ended prematurely?

Main objective of the trial

To determine the pharmacokinetics (PK) of pramipexole (PPX) after administration of a single dose orally (p.o.) in pediatric patients with the diagnosis of Restless Legs Syndrome (RLS).

Protection of trial subjects

Only subjects that met all the study inclusion and none of the exclusion criteria were to be entered in the study. All subjects were free to withdraw from the clinical trial at any time for any reason given. Close monitoring of all subjects was adhered to throughout the trial conduct. Rescue medication was allowed for all patients as required.

Background therapy

Evidence for comparator

Actual start date of recruitment

23 Mar 2006

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

United States: 35

Worldwide total number of subjects

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

Top of page

Recruitment details

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.

Screening details

All subjects were screened for eligibility to participate in the trial. Subjects attended specialist sites which would then ensure that they (the subjects) met all strictly implemented inclusion/exclusion criteria. Subjects were not to be provided the trial treatment if any one of the specific entry criteria were violated.

Period 1 title

Treatment period (overall period)

Is this the baseline period?

Yes

Allocation method

Non-randomised - controlled

Blinding used

Not blinded

Blinding implementation details

This study was an open-label PK study.

Are arms mutually exclusive

Yes

PPX (MIRAPEX®, 0.125 mg)

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

MIRAPEX®

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

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)

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

MIRAPEX®

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

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)

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

MIRAPEX®

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

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 subjects in period 1 ^[1]	PPX (MIRAPEX®, 0.125 mg)	PPX (MIRAPEX®, 0.25 mg)	PPX (MIRAPEX®, 0.5 mg)
Started	9	15	2
Completed	9	14	1
Not completed	0	1	1
Consent withdrawn by subject	-	1	-
AE Other	-	-	1

Notes
[1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
Justification: Baseline characteristics are based on patients who were randomised after successfully completing the screening period and received at least one of the trial medication.

Baseline characteristics

Top of page

Reporting group title

PPX (MIRAPEX®, 0.125 mg)

Reporting group description

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.

Reporting group title

PPX (MIRAPEX®, 0.25 mg)

Reporting group description

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.

Reporting group title

PPX (MIRAPEX®, 0.5 mg)

Reporting group description

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.

Reporting group values	PPX (MIRAPEX®, 0.125 mg)	PPX (MIRAPEX®, 0.25 mg)	PPX (MIRAPEX®, 0.5 mg)	Total
Number of subjects	9	15	2	26
Age categorical
Units: Subjects
Age Continuous \|
The safety analysis set was used. Safety analysis set : The safety population comprised all patients who provided informed consent and received at least one dose of study drug.
Units: years
arithmetic mean (standard deviation)	10.6 ( 4.3 )	11.4 ( 3.4 )	15 ( 0 )	-
Gender, Male/Female
Units: participants
Female	5	5	2	12
Male	4	10	0	14

End points

Top of page

Reporting group title

PPX (MIRAPEX®, 0.125 mg)

Reporting group description

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.

Reporting group title

PPX (MIRAPEX®, 0.25 mg)

Reporting group description

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.

Reporting group title

PPX (MIRAPEX®, 0.5 mg)

Reporting group description

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.

Primary: Cmax,ss

Top of page

End point title

Cmax,ss ^[1]

End point description

Maximum concentration of the pramipexole (PPX) in plasma at steady state over a uniform dosing interval (Cmax,ss). Pharmacokinetic Set (PKS): 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. Patients were stratified into two age groups for analysis: 6 to < 12 years and 12 to < 18 years 99999 (PPX (MIRAPEX®, 0.5 mg), 6 to < 12 years): No patients were recruited for this category. 99999 (PPX (MIRAPEX®, 0.5 mg), 12 to < 18 years): 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) are not calculated according to internal rules.

End point type

Primary

End point 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 adminstration on day 1.

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was evaluated only descriptively. Thus, no statistical hypothesis were tested.

End point values	PPX (MIRAPEX®, 0.125 mg)	PPX (MIRAPEX®, 0.25 mg)	PPX (MIRAPEX®, 0.5 mg)
Number of subjects analysed	9 ^[2]	15 ^[3]	2 ^[4]
Units: ng/mL
geometric mean (geometric coefficient of variation)
6 to <12 years (N=5, 9, 0)	0.633 ( 26.2 )	1.13 ( 35.3 )	99999 ( 99999 )
12 to <18 years(N=4, 6, 2))	0.396 ( 30 )	0.677 ( 40.3 )	99999 ( 99999 )

Notes
[2] - Pharmacokinetic Set (PKS)
[3] - Pharmacokinetic Set (PKS)
[4] - Pharmacokinetic Set (PKS)

No statistical analyses for this end point

Primary: Cmin,ss

Top of page

End point title

Cmin,ss ^[5]

End point description

Minimum measured concentration of the pramipexole in plasma at steady state over a uniform dosing interval (Cmin,ss). Patients were stratified into two age groups for analysis: 6 to < 12 years and 12 to < 18 years 99999 (PPX (MIRAPEX®, 0.5 mg), 6 to < 12 years): No patients were recruited for this category. 99999 (PPX (MIRAPEX®, 0.5 mg), 12 to < 18 years): The reliable estimation can only be performed when at least 2/3 of the data are available and thus the gMean and gCV are not calculated according to internal rules.

End point type

Primary

End point timeframe

0.25 h before the drug administration on day 1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7 h, 12 h and 24 h after the last drug adminstration on day 1.

Notes
[5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was evaluated only descriptively. Thus, no statistical hypothesis were tested.

End point values	PPX (MIRAPEX®, 0.125 mg)	PPX (MIRAPEX®, 0.25 mg)	PPX (MIRAPEX®, 0.5 mg)
Number of subjects analysed	9 ^[6]	15 ^[7]	2 ^[8]
Units: ng/mL
geometric mean (geometric coefficient of variation)
6 to <12 years (N=5, 9, 0)	0.0872 ( 35.5 )	0.136 ( 99.5 )	99999 ( 99999 )
12 to <18 years(N=4, 6, 2)	0.0972 ( 37.5 )	0.122 ( 53.8 )	99999 ( 99999 )

Notes
[6] - Pharmacokinetic Set (PKS)
[7] - Pharmacokinetic Set (PKS)
[8] - Pharmacokinetic Set (PKS)

No statistical analyses for this end point

Primary: Cpre,N

Top of page

End point title

Cpre,N ^[9]

End point description

Predose concentration of the pramipexole in plasma at steady state immediately before administration of the next dose N (Cpre,N). Patients were stratified into two age groups for analysis: 6 to < 12 years and 12 to < 18 years 99999 (PPX (MIRAPEX®, 0.5 mg), 6 to < 12 years): No patients were recruited for this category. 99999 (PPX (MIRAPEX®, 0.5 mg) & PPX (MIRAPEX®, 0.125 mg), 12 to < 18 years): The reliable estimation can only be performed when at least 2/3 of the data are available and thus the gMean and gCV are not calculated according to internal rules.

End point type

Primary

End point timeframe

0.25 h before the drug administration on day 1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7 h, 12 h and 24 h after the last drug adminstration on day 1.

Notes
[9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was evaluated only descriptively. Thus, no statistical hypothesis were tested.

End point values	PPX (MIRAPEX®, 0.125 mg)	PPX (MIRAPEX®, 0.25 mg)	PPX (MIRAPEX®, 0.5 mg)
Number of subjects analysed	9 ^[10]	15 ^[11]	2 ^[12]
Units: ng/mL
geometric mean (geometric coefficient of variation)
6 to <12 years (N=4, 8, 0)	0.074 ( 17.3 )	0.147 ( 75.3 )	99999 ( 99999 )
12 to <18 years (N=1, 5, 1)	99999 ( 99999 )	0.112 ( 60.7 )	99999 ( 99999 )

Notes
[10] - Pharmacokinetic Set (PKS) 4 subjects were not analysed as their data were not evaluable.
[11] - Pharmacokinetic Set (PKS) 2 subjects were not analysed as their data were not evaluable.
[12] - Pharmacokinetic Set (PKS) 1 subject was not analysed as its data was not evaluable.

No statistical analyses for this end point

Primary: Cavg

Top of page

End point title

Cavg ^[13]

End point description

Average concentration of the pramipexole in plasma at steady state (Cavg). Patients were stratified into two age groups for analysis: 6 to < 12 years and 12 to < 18 years 99999 (PPX (MIRAPEX®, 0.5 mg), 6 to < 12 years): No patients were recruited for this category. 99999 (PPX (MIRAPEX®, 0.5 mg), 12 to < 18 years): The reliable estimation can only be performed when at least 2/3 of the data are available and thus the gMean and gCV are not calculated according to internal rules.

End point type

Primary

End point timeframe

0.25h before the drug administration on day 1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7 h, 12 h and 24 h after the last drug adminstration on day 1.

Notes
[13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was evaluated only descriptively. Thus, no statistical hypothesis were tested.

End point values	PPX (MIRAPEX®, 0.125 mg)	PPX (MIRAPEX®, 0.25 mg)	PPX (MIRAPEX®, 0.5 mg)
Number of subjects analysed	9 ^[14]	15 ^[15]	2 ^[16]
Units: ng/mL
geometric mean (geometric coefficient of variation)
6 to <12 years (N=5, 8, 0)	0.213 ( 27.4 )	0.458 ( 42.8 )	99999 ( 99999 )
12 to <18 years (N=4, 6, 1)	0.137 ( 21.3 )	0.309 ( 35.2 )	99999 ( 99999 )

Notes
[14] - Pharmacokinetic Set (PKS)
[15] - Pharmacokinetic Set (PKS) 1 subject was not analysed as its data was not evaluable.
[16] - Pharmacokinetic Set (PKS) 1 subject was not analysed as its data was not evaluable.

No statistical analyses for this end point

Primary: tmax,ss

Top of page

End point title

tmax,ss ^[17]

End point description

Time from dosing to maximum concentration at steady state (tmax,ss). Patients were stratified into two age groups for analysis: 6 to < 12 years and 12 to < 18 years 99999 (PPX (MIRAPEX®, 0.5 mg), 6 to < 12 years): No patients were recruited for this category. 99999 (PPX (MIRAPEX®, 0.5 mg), 12 to < 18 years): 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.

End point type

Primary

End point timeframe

0.25 h before the drug administration on day 1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7 h, 12 h and 24 h after the last drug administration on day 1.

Notes
[17] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was evaluated only descriptively. Thus, no statistical hypothesis were tested.

End point values	PPX (MIRAPEX®, 0.125 mg)	PPX (MIRAPEX®, 0.25 mg)	PPX (MIRAPEX®, 0.5 mg)
Number of subjects analysed	9 ^[18]	15 ^[19]	2 ^[20]
Units: hours
median (full range (min-max))
6 to <12 years (N=5, 9, 0)	2 (1 to 2)	2 (1 to 3)	99999 (99999 to 99999)
12 to <18 years (N=4, 6, 2)	2 (0.5 to 2)	1.96 (0.5 to 5)	99999 (99999 to 99999)

Notes
[18] - Pharmacokinetic Set (PKS)
[19] - Pharmacokinetic Set (PKS)
[20] - Pharmacokinetic Set (PKS)

No statistical analyses for this end point

Primary: tmin,ss

Top of page

End point title

tmin,ss ^[21]

End point description

Time from dosing to minimum concentration at steady state (tmin,ss ). Patients were stratified into two age groups for analysis: 6 to < 12 years and 12 to < 18 years 99999 (PPX (MIRAPEX®, 0.5 mg), 6 to < 12 years): No patients were recruited for this category. 99999 (PPX (MIRAPEX®, 0.5 mg), 12 to < 18 years): 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.

End point type

Primary

End point timeframe

0.25 h before the drug administration on day 1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7 h, 12 h and 24 h after the last drug administration on day 1.

Notes
[21] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was evaluated only descriptively. Thus, no statistical hypothesis were tested.

End point values	PPX (MIRAPEX®, 0.125 mg)	PPX (MIRAPEX®, 0.25 mg)	PPX (MIRAPEX®, 0.5 mg)
Number of subjects analysed	9 ^[22]	15 ^[23]	2 ^[24]
Units: hours
median (full range (min-max))
6 to <12 years (N=5, 9, 0)	12 (0.5 to 24)	24 (0.25 to 24)	99999 (99999 to 99999)
12 to <18 years (N=4, 6, 2)	6.25 (0.5 to 12)	23.9 (0.5 to 24)	99999 (99999 to 99999)

Notes
[22] - Pharmacokinetic Set (PKS)
[23] - Pharmacokinetic Set (PKS)
[24] - Pharmacokinetic Set (PKS)

No statistical analyses for this end point

Primary: AUCτ,ss

Top of page

End point title

AUCτ,ss ^[25]

End point description

Area under the concentration-time curve of the pramipexole in plasma at steady state over a uniform dosing interval (AUCτ,ss ). Patients were stratified into two age groups for analysis: 6 to < 12 years and 12 to < 18 years 99999 (PPX (MIRAPEX®, 0.5 mg), 6 to < 12 years): No patients were recruited for this category. 99999 (PPX (MIRAPEX®, 0.5 mg), 12 to < 18 years): The reliable estimation can only be performed when at least 2/3 of the data are available and thus the gMean and gCV are not calculated according to internal rules.

End point type

Primary

End point timeframe

0.25 h before the drug administration on day 1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7 h, 12 h and 24 h after the last drug adminstration on day 1.

Notes
[25] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was evaluated only descriptively. Thus, no statistical hypothesis were tested.

End point values	PPX (MIRAPEX®, 0.125 mg)	PPX (MIRAPEX®, 0.25 mg)	PPX (MIRAPEX®, 0.5 mg)
Number of subjects analysed	9 ^[26]	15 ^[27]	2 ^[28]
Units: ng*h/mL
geometric mean (geometric coefficient of variation)
6 to <12 years (N=5, 8, 0)	5.12 ( 27.4 )	11 ( 42.8 )	99999 ( 99999 )
12 to <18 years (N=4, 6, 1)	3.28 ( 21.3 )	7.42 ( 35.2 )	99999 ( 99999 )

Notes
[26] - Pharmacokinetic Set (PKS)
[27] - Pharmacokinetic Set (PKS) 1 subject was not analysed as its data was not evaluable.
[28] - Pharmacokinetic Set (PKS) 1 subject was not analysed as its data was not evaluable.

No statistical analyses for this end point

Primary: λz,ss

Top of page

End point title

λz,ss ^[29]

End point description

Terminal rate constant in plasma at steady state (λz,ss ). Patients were stratified into two age groups for analysis: 6 to < 12 years and 12 to < 18 years 99999 (PPX (MIRAPEX®, 0.5 mg), 6 to < 12 years): No patients were recruited for this category. 99999 (PPX (MIRAPEX®, 0.5 mg), 12 to < 18 years): The reliable estimation can only be performed when at least 2/3 of the data are available and thus the gMean and gCV are not calculated according to internal rules.

End point type

Primary

End point timeframe

0.25h before the drug administration on day 1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7 h, 12 h and 24 h after the last drug administration on day 1.

Notes
[29] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was evaluated only descriptively. Thus, no statistical hypothesis were tested.

End point values	PPX (MIRAPEX®, 0.125 mg)	PPX (MIRAPEX®, 0.25 mg)	PPX (MIRAPEX®, 0.5 mg)
Number of subjects analysed	9 ^[30]	15 ^[31]	2 ^[32]
Units: 1/h
geometric mean (geometric coefficient of variation)
6 to <12 years (N=5, 8, 0)	0.132 ( 22.6 )	0.107 ( 20.1 )	99999 ( 99999 )
12 to <18 years (N=4, 6, 1)	0.113 ( 1.88 )	0.0938 ( 25.4 )	99999 ( 99999 )

Notes
[30] - Pharmacokinetic Set (PKS)
[31] - Pharmacokinetic Set (PKS) 1 subject was not analysed as its data was not evaluable.
[32] - Pharmacokinetic Set (PKS) 1 subject was not analysed as its data was not evaluable.

No statistical analyses for this end point

Primary: t1/2,ss

Top of page

End point title

t1/2,ss ^[33]

End point description

Terminal half-life of the pramipexole in plasma at steady state (t1/2,ss ). Patients were stratified into two age groups for analysis: 6 to < 12 years and 12 to < 18 years 99999 (PPX (MIRAPEX®, 0.5 mg), 6 to < 12 years): No patients were recruited for this category. 99999 (PPX (MIRAPEX®, 0.5 mg), 12 to < 18 years): The reliable estimation can only be performed when at least 2/3 of the data are available and thus the gMean and gCV are not calculated according to internal rules.

End point type

Primary

End point timeframe

0.25 h before the drug administration on day 1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7 h, 12 h and 24 h after the last drug administration on day 1.

Notes
[33] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was evaluated only descriptively. Thus, no statistical hypothesis were tested.

End point values	PPX (MIRAPEX®, 0.125 mg)	PPX (MIRAPEX®, 0.25 mg)	PPX (MIRAPEX®, 0.5 mg)
Number of subjects analysed	9 ^[34]	15 ^[35]	2 ^[36]
Units: hours
geometric mean (geometric coefficient of variation)
6 to <12 years (N=5, 8, 0)	5.26 ( 22.6 )	6.5 ( 20.1 )	99999 ( 99999 )
12 to <18 years (N=4, 6, 1)	6.13 ( 1.88 )	7.39 ( 25.4 )	99999 ( 99999 )

Notes
[34] - Pharmacokinetic Set (PKS)
[35] - Pharmacokinetic Set (PKS) 1 subject was not analysed as its data was not evaluable.
[36] - Pharmacokinetic Set (PKS) 1 subject was not analysed as its data was not evaluable.

No statistical analyses for this end point

Primary: MRTpo,ss

Top of page

End point title

MRTpo,ss ^[37]

End point description

Mean residence time of the pramipexole in the body at steady state (MRTpo,ss). Patients were stratified into two age groups for analysis: 6 to < 12 years and 12 to < 18 years 99999 (PPX (MIRAPEX®, 0.5 mg), 6 to < 12 years): No patients were recruited for this category. 99999 (PPX (MIRAPEX®, 0.5 mg), 12 to < 18 years): The reliable estimation can only be performed when at least 2/3 of the data are available and thus the gMean and gCV are not calculated according to internal rules.

End point type

Primary

End point timeframe

0.25 h before the drug administration on day 1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7 h, 12 h and 24 h after the last drug adminstration on day 1.

Notes
[37] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was evaluated only descriptively. Thus, no statistical hypothesis were tested.

End point values	PPX (MIRAPEX®, 0.125 mg)	PPX (MIRAPEX®, 0.25 mg)	PPX (MIRAPEX®, 0.5 mg)
Number of subjects analysed	9 ^[38]	15 ^[39]	2 ^[40]
Units: hours
geometric mean (geometric coefficient of variation)
6 to <12 years (N=5, 8, 0)	8.19 ( 13.1 )	10.1 ( 19.5 )	99999 ( 99999 )
12 to <18 years (N=4, 6, 1)	9.47 ( 5.3 )	11.6 ( 23.3 )	99999 ( 99999 )

Notes
[38] - Pharmacokinetic Set (PKS)
[39] - Pharmacokinetic Set (PKS) 1 subject was not analysed as its data was not evaluable.
[40] - Pharmacokinetic Set (PKS) 1 subject was not analysed as its data was not evaluable.

No statistical analyses for this end point

Primary: CL/F,ss

Top of page

End point title

CL/F,ss ^[41]

End point description

Apparent clearance of the pramipexole in the plasma after extravascular administration at steady state; F = absolute bioavailability factor (CL/F,ss ). Patients were stratified into two age groups for analysis: 6 to < 12 years and 12 to < 18 years 99999 (PPX (MIRAPEX®, 0.5 mg), 6 to < 12 years): No patients were recruited for this category. 99999 (PPX (MIRAPEX®, 0.5 mg), 12 to < 18 years): The reliable estimation can only be performed when at least 2/3 of the data are available and thus the gMean and gCV are not calculated according to internal rules.

End point type

Primary

End point timeframe

0.25 h before the drug administration on day 1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7 h, 12 h and 24 h after the last drug administration on day 1.

Notes
[41] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was evaluated only descriptively. Thus, no statistical hypothesis were tested.

End point values	PPX (MIRAPEX®, 0.125 mg)	PPX (MIRAPEX®, 0.25 mg)	PPX (MIRAPEX®, 0.5 mg)
Number of subjects analysed	9 ^[42]	15 ^[43]	2 ^[44]
Units: mL/min
geometric mean (geometric coefficient of variation)
6 to <12 years (N=5, 8, 0)	284 ( 27.4 )	265 ( 42.8 )	99999 ( 99999 )
12 to <18 years (N=4, 6, 1)	444 ( 21.3 )	393 ( 35.2 )	99999 ( 99999 )

Notes
[42] - Pharmacokinetic Set (PKS)
[43] - Pharmacokinetic Set (PKS) 1 subject was not analysed as its data was not evaluable.
[44] - Pharmacokinetic Set (PKS) 1 subject was not analysed as its data was not evaluable.

No statistical analyses for this end point

Primary: Vz/F,ss

Top of page

End point title

Vz/F,ss ^[45]

End point description

Apparent volume of distribution during the terminal phase λz following an extravascular dose at steady state (Vz/F,ss ). Patients were stratified into two age groups for analysis: 6 to < 12 years and 12 to < 18 years 99999 (PPX (MIRAPEX®, 0.5 mg), 6 to < 12 years): No patients were recruited for this category. 99999 (PPX (MIRAPEX®, 0.5 mg), 12 to < 18 years): The reliable estimation can only be performed when at least 2/3 of the data are available and thus the gMean and gCV are not calculated according to internal rules.

End point type

Primary

End point timeframe

0.25 h before the drug administration on day 1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7 h, 12 h and 24 h after the last drug administration on day 1.

Notes
[45] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was evaluated only descriptively. Thus, no statistical hypothesis were tested.

End point values	PPX (MIRAPEX®, 0.125 mg)	PPX (MIRAPEX®, 0.25 mg)	PPX (MIRAPEX®, 0.5 mg)
Number of subjects analysed	9 ^[46]	15 ^[47]	2 ^[48]
Units: Litres
geometric mean (geometric coefficient of variation)
6 to <12 years (N=5, 8, 0)	129 ( 12.3 )	149 ( 29.7 )	99999 ( 99999 )
12 to <18 years (N=4, 6, 1)	236 ( 19.4 )	251 ( 37.3 )	99999 ( 99999 )

Notes
[46] - Pharmacokinetic Set (PKS)
[47] - Pharmacokinetic Set (PKS) 1 subject was not analysed as its data was not evaluable.
[48] - Pharmacokinetic Set (PKS) 1 subject was not analysed as its data was not evaluable.

No statistical analyses for this end point

Primary: Ae 0-12,ss

Top of page

End point title

Ae 0-12,ss ^[49]

End point description

Amount of pramipexole that is eliminated in urine at steady state over a time interval t1 to t2 (0-12h), (Ae 0-12,ss). Patients were stratified into two age groups for analysis: 6 to < 12 years and 12 to < 18 years For arm MIRAPEX® 0.5mg (6 to < 12 years): No patients were recruited for this category and for (12 to < 18 years): No subjects were analysed as the data were not evaluable.

End point type

Primary

End point timeframe

12 hours after last study drug administration on day 1

Notes
[49] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was evaluated only descriptively. Thus, no statistical hypothesis were tested.

End point values	PPX (MIRAPEX®, 0.125 mg)	PPX (MIRAPEX®, 0.25 mg)	PPX (MIRAPEX®, 0.5 mg)
Number of subjects analysed	9 ^[50]	15 ^[51]	2 ^[52]
Units: ng
geometric mean (geometric coefficient of variation)
6 to <12 years (N=4, 6, 0)	50600 ( 14.6 )	123000 ( 50.7 )	99999 ( 99999 )
12 to <18 years (N=3, 6, 0)	55200 ( 41.5 )	82300 ( 52.7 )	99999 ( 99999 )

Notes
[50] - Pharmacokinetic Set (PKS) 2 subjects were not analysed as their data were not evaluable.
[51] - Pharmacokinetic Set (PKS) 3 subjects were not analysed as their data were not evaluable.
[52] - No subjects were analysed as the data were not evaluable.

No statistical analyses for this end point

Primary: fe 0-12,ss

Top of page

End point title

fe 0-12,ss ^[53]

End point description

Fraction of administered drug excreted unchanged in urine at steady state over a time interval t1 to t2 (0-12h), (fe 0-12,ss ). Patients were stratified into two age groups for analysis: 6 to < 12 years and 12 to < 18 years For arm MIRAPEX® 0.5mg (6 to <12 years): No patients were recruited for this category and for (12 to <18 years): No subjects were analysed as the data were not evaluable. 99999 (PPX (MIRAPEX®, 0.125 mg), 12 to <18 years): The reliable estimation can only be performed when at least 2/3 of the data are available and thus the gMean and gCV are not calculated according to internal rules. 99999 (PPX (MIRAPEX®, 0.25 mg), 6 to <12 years): The reliable estimation can only be performed when at least 2/3 of the data are available and thus the gMean and gCV are not calculated according to internal rules.

End point type

Primary

End point timeframe

12 hours after last study drug administration on day 1.

Notes
[53] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was evaluated only descriptively. Thus, no statistical hypothesis were tested.

End point values	PPX (MIRAPEX®, 0.125 mg)	PPX (MIRAPEX®, 0.25 mg)	PPX (MIRAPEX®, 0.5 mg)
Number of subjects analysed	9 ^[54]	15 ^[55]	2 ^[56]
Units: % of pramipexole excreted
geometric mean (geometric coefficient of variation)
6 to <12 years (N=4, 2, 0)	58 ( 14.6 )	99999 ( 99999 )	99999 ( 99999 )
12 to <18 years (N=2, 5, 0)	99999 ( 99999 )	42 ( 48.1 )	99999 ( 99999 )

Notes
[54] - Pharmacokinetic Set (PKS) 3 subjects were not analysed as their data were not evaluable.
[55] - Pharmacokinetic Set (PKS) 8 subjects were not analysed as their data were not evaluable.
[56] - No subjects were analysed as the data were not evaluable.

No statistical analyses for this end point

Primary: CLR 0-12,ss

Top of page

End point title

CLR 0-12,ss ^[57]

End point description

Renal clearance of the pramipexole at steady state (CLR 0-12,ss ). Patients were stratified into two age groups for analysis: 6 to < 12 years and 12 to < 18 years For arm PPX (MIRAPEX®, 0.5mg) , 6 to < 12 years): No patients were recruited for this category and for (12 to < 18 years): No subjects were analysed as the data were not evaluable. 99999 (PPX (MIRAPEX®, 0.125 mg), 12 to < 18 years): The reliable estimation can only be performed when at least 2/3 of the data are available and thus the gMean and gCV are not calculated according to internal rules. 99999 (MIRAPEX® (0.25 mg), 6 to < 12 years): The reliable estimation can only be performed when at least 2/3 of the data are available and thus the gMean and gCV are not calculated according to internal rules.

End point type

Primary

End point timeframe

12h after last study drug administration on day 1

Notes
[57] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was evaluated only descriptively. Thus, no statistical hypothesis were tested.

End point values	PPX (MIRAPEX®, 0.125 mg)	PPX (MIRAPEX®, 0.25 mg)	PPX (MIRAPEX®, 0.5 mg)
Number of subjects analysed	9 ^[58]	15 ^[59]	2 ^[60]
Units: mL/min
geometric mean (geometric coefficient of variation)
6 to <12 years (N=4, 2, 0)	201 ( 34.1 )	99999 ( 99999 )	99999 ( 99999 )
12 to <18 years (N=2, 5, 0)	99999 ( 99999 )	253 ( 34.1 )	99999 ( 99999 )

Notes
[58] - Pharmacokinetic Set (PKS) 3 subjects were not analysed as their data were not evaluable.
[59] - Pharmacokinetic Set (PKS) 8 subjects were not analysed as their data were not evaluable.
[60] - No subjects were analysed as the data were not evaluable.

No statistical analyses for this end point

Primary: PTF

Top of page

End point title

PTF ^[61]

End point description

Peak-trough fluctuation (PTF) is defined as the difference between Cmax and Cmin divided by Cavg and multiplied with 100% at steady-state. Patients were stratified into two age groups for analysis: 6 to < 12 years and 12 to < 18 years 99999 (PPX (MIRAPEX®, 0.5 mg), 6 to < 12 years): No patients were recruited for this category. 99999 (PPX (MIRAPEX®, 0.5 mg), 12 to < 18 years): The reliable estimation can only be performed when at least 2/3 of the data are available and thus the gMean and gCV are not calculated according to internal rules.

End point type

Primary

End point timeframe

0.25h before the drug administration on day 1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7 h, 12 h and 24 h after the last drug adminstration on day 1.

Notes
[61] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was evaluated only descriptively. Thus, no statistical hypothesis were tested.

End point values	PPX (MIRAPEX®, 0.125 mg)	PPX (MIRAPEX®, 0.25 mg)	PPX (MIRAPEX®, 0.5 mg)
Number of subjects analysed	9 ^[62]	15 ^[63]	2 ^[64]
Units: % of PTF
geometric mean (geometric coefficient of variation)
6 to <12 years (N=5, 8, 0)	250 ( 10.1 )	209 ( 31.8 )	99999 ( 99999 )
12 to <18 years (N=4, 6, 1)	216 ( 24 )	168 ( 34.2 )	99999 ( 99999 )

Notes
[62] - Pharmacokinetic Set (PKS)
[63] - Pharmacokinetic Set (PKS) 1 subject was not analysed as its data was not evaluable.
[64] - Pharmacokinetic Set (PKS) 1 subject was not analysed as its data was not evaluable.

No statistical analyses for this end point

Secondary: Number of patients with drug related adverse events

Top of page

End point title

Number of patients with drug related adverse events

End point description

Number of patients with adverse events due to study drug. Safety Set: The safety population comprised all patients who provided informed consent and received at least one dose of study drug.

End point type

Secondary

End point timeframe

From first drug administration until 24 hours after last study drug administration, upto 48 days

End point values	PPX (MIRAPEX®, 0.125 mg)	PPX (MIRAPEX®, 0.25 mg)	PPX (MIRAPEX®, 0.5 mg)
Number of subjects analysed	9	15	2
Units: Participants	1	0	1

No statistical analyses for this end point

Secondary: Vital Signs (Systolic and Diastolic Blood Pressure)

Top of page

End point title

Vital Signs (Systolic and Diastolic Blood Pressure)

End point description

Vital signs (systolic and diastolic blood pressure (both supine and after standing for 1 minute)). 99999 (PPX (MIRAPEX®, 0.5 mg)): The data of only one patient is available and thus standard deviation is not calculable.

End point type

Secondary

End point 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

End point values	PPX (MIRAPEX®, 0.125 mg)	PPX (MIRAPEX®, 0.25 mg)	PPX (MIRAPEX®, 0.5 mg)
Number of subjects analysed	9 ^[65]	15 ^[66]	2 ^[67]
Units: mmHg
arithmetic mean (standard deviation)
Systolic blood pressure−supine(N= 9,15,2): −0:15h	109.33 ( 6.76 )	109.2 ( 10.8 )	117 ( 4.24 )
Systolic blood pressure−supine(N= 9,15,2): 0:30h	112.89 ( 13.9 )	110.33 ( 14.07 )	116 ( 4.24 )
Systolic blood pressure−supine(N= 9,15,2): 1:00h	113 ( 11.07 )	108.07 ( 12.92 )	105.5 ( 0.71 )
Systolic blood pressure-supine(N= 9,15,2): 2:00h	111 ( 7.43 )	111.93 ( 13.79 )	113 ( 9.9 )
Systolic blood pressure-supine(N= 9,15,1): 3:00h	106.89 ( 10.4 )	110.53 ( 11.34 )	113 ( 99999 )
Systolic blood pressure-supine(N= 9,15,1): 5:00h	105.11 ( 12.71 )	108.8 ( 14.89 )	104 ( 99999 )
Systolic blood pressure-supine(N= 9,14,1): 7:00h	108.44 ( 12.27 )	109.86 ( 14.11 )	108 ( 99999 )
Systolic blood pressure-supine(N= 9,14,1): 12:00h	107.56 ( 16.38 )	106.93 ( 16.28 )	109 ( 99999 )
Systolic blood pressure-supine(N= 9,14,1): 24:00h	109.22 ( 11.38 )	112.21 ( 13.76 )	120 ( 99999 )
Diastolic blood pressure-supine(N= 9,15,2): -0:15	66.67 ( 7.35 )	65.73 ( 10.19 )	76 ( 0 )
Diastolic blood pressure-supine(N= 9,15,2): 0:30	68.67 ( 8.93 )	65.8 ( 12.62 )	73 ( 2.83 )
Diastolic blood pressure-supine(N= 9,15,2): 1:00	69.33 ( 6.52 )	65.73 ( 7.8 )	64 ( 12.73 )
Diastolic blood pressure-supine(N= 9,15,2): 2:00	66 ( 8.23 )	65.8 ( 8.76 )	75 ( 8.49 )
Diastolic blood pressure-supine(N= 9,15,1): 3:00	66.78 ( 9.36 )	65.4 ( 9.96 )	75 ( 99999 )
Diastolic blood pressure-supine(N= 9,15,1): 5:00	64.22 ( 9.83 )	63.87 ( 9.78 )	70 ( 99999 )
Diastolic blood pressure-supine(N= 9,14,1): 7:00	67.56 ( 13.47 )	62.43 ( 8.08 )	67 ( 99999 )
Diastolic blood pressure-supine(N= 9,14,1): 12:00	70 ( 12.03 )	61 ( 9.12 )	66 ( 99999 )
Diastolic blood pressure-supine(N= 9,14,1): 24:00	66.56 ( 6 )	65.71 ( 7.61 )	78 ( 99999 )
Systolic blood pressure-standing(N= 9,15,2): -0:15	109.89 ( 8.57 )	113.93 ( 9.97 )	122 ( 9.9 )
Systolic blood pressure-standing(N= 9,15,2): 0:30h	113.56 ( 13.62 )	113.67 ( 13.69 )	115.5 ( 6.36 )
Systolic blood pressure-standing(N= 9,15,2): 1:00h	110.11 ( 13.81 )	110.07 ( 14.26 )	125.5 ( 23.33 )
Systolic blood pressure-standing(N= 9,15,2): 2:00h	110.33 ( 8.76 )	112.27 ( 12.26 )	115 ( 2.83 )
Systolic blood pressure-standing(N= 9,15,1): 3:00h	110.11 ( 16.5 )	113.07 ( 16.15 )	108 ( 99999 )
Systolic blood pressure-standing(N= 9,14,1): 5:00h	110.22 ( 11.88 )	111.93 ( 14.91 )	115 ( 99999 )
Systolic blood pressure-standing(N= 9,13,1): 7:00h	109.11 ( 11.76 )	103.85 ( 17.56 )	65 ( 99999 )
Systolic blood pressure-standing(N=9,14,1): 12:00h	108.22 ( 9.59 )	107.14 ( 15.83 )	100 ( 99999 )
Systolic blood pressure-standing(N=9,14,1): 24:00h	113.89 ( 11.25 )	115.5 ( 14.43 )	102 ( 99999 )
Diastolic blood pressure-standing(N=9,15,2): -0:15	68.11 ( 11.87 )	71.2 ( 8.09 )	86 ( 0 )
Diastolic blood pressure-standing(N=9,15,2): 0:30h	70.11 ( 7.44 )	69.2 ( 12.11 )	80 ( 1.41 )
Diastolic blood pressure-standing(N=9,15,2): 1:00h	69.22 ( 6.36 )	72 ( 9.54 )	91 ( 7.07 )
Diastolic blood pressure-standing(N=9,15,2): 2:00h	71.11 ( 8.82 )	73.13 ( 9.36 )	86.5 ( 3.54 )
Diastolic blood pressure-standing(N=9,15,1): 3:00h	72.67 ( 5.94 )	71.47 ( 8.98 )	79 ( 99999 )
Diastolic blood pressure-standing(N=9,14,1): 5:00h	74 ( 10.82 )	70.57 ( 9.2 )	98 ( 99999 )
Diastolic blood pressure-standing(N=9,13,1): 7:00h	72 ( 13.01 )	66.69 ( 10.9 )	48 ( 99999 )
Diastolic blood pressure-standing(N=9,14,1):12:00h	74.33 ( 11.19 )	70.07 ( 10.51 )	62 ( 99999 )
Diastolic blood pressure-standing(N=9,14,1):24:00h	73.11 ( 8.13 )	73.57 ( 9.62 )	84 ( 99999 )

Notes
[65] - Safety Set
[66] - Safety Set
[67] - Safety Set

No statistical analyses for this end point

Secondary: Vital Signs (Pulse Rate)

Top of page

End point title

Vital Signs (Pulse Rate)

End point description

Vital signs (Pulse rate (both supine and after standing for 1 minute)). 99999 (PPX (MIRAPEX®, 0.5 mg)): The data of only one patient is available and thus standard deviation is not calculable.

End point type

Secondary

End point timeframe

-0:15h(hours) pre-dose, and 0:30h, 1:00h, 2:00h, 3:00h, 5:00h, 7:00h, 12:00h, 24:00h

End point values	PPX (MIRAPEX®, 0.125 mg)	PPX (MIRAPEX®, 0.25 mg)	PPX (MIRAPEX®, 0.5 mg)
Number of subjects analysed	9 ^[68]	15 ^[69]	2 ^[70]
Units: bpm
arithmetic mean (standard deviation)
Pulse rate−supine(N= 9,15,2): −0:15h	82.4 ( 18.6 )	73.3 ( 6.8 )	75.5 ( 24.7 )
Pulse rate−supine(N= 9,15,2): 0:30h	76.7 ( 17.5 )	78 ( 11.7 )	92 ( 32.5 )
Pulse rate−supine(N= 9,15,2): 1:00h	82.7 ( 22.2 )	75.2 ( 6.8 )	87 ( 36.8 )
Pulse rate−supine(N= 9,15,2): 2:00h	85.4 ( 19.6 )	77.9 ( 8 )	94.5 ( 26.2 )
Pulse rate−supine(N= 9,15,1): 3:00h	89.3 ( 19.1 )	79.9 ( 13.6 )	72 ( 99999 )
Pulse rate−supine(N= 9,15,1): 5:00h	82.7 ( 16 )	75.9 ( 6.9 )	77 ( 99999 )
Pulse rate−supine(N= 9,14,1): 7:00h	88.1 ( 18.1 )	72 ( 9 )	78 ( 99999 )
Pulse rate−supine(N= 9,14,1): 12:00h	77.8 ( 15.2 )	68.6 ( 6.2 )	69 ( 99999 )
Pulse rate−supine(N= 9,14,1): 24:00h	77.9 ( 13.6 )	77.6 ( 8.5 )	77 ( 99999 )
Pulse rate− standing(N=9,15,2): −0:15h	90.8 ( 18.3 )	79.4 ( 8.7 )	99 ( 22.6 )
Pulse rate− standing(N=9,15,2): 0:30h	84.7 ( 15.5 )	81.5 ( 12.2 )	103 ( 27.6 )
Pulse rate− standing(N=9,15,2): 1:00h	94.8 ( 20.3 )	85.4 ( 10.9 )	123 ( 43.1 )
Pulse rate− standing(N=9,15,2): 2:00h	92.8 ( 17 )	89.3 ( 11.2 )	121 ( 1.4 )
Pulse rate− standing(N=9,15,1): 3:00h	99 ( 18.2 )	92.7 ( 12.9 )	109 ( 99999 )
Pulse rate− standing(N=9,14,1): 5:00h	99.3 ( 27 )	87.1 ( 11.4 )	76 ( 99999 )
Pulse rate− standing(N=9,13,1): 7:00h	100 ( 17 )	82.1 ( 14.4 )	72 ( 99999 )
Pulse rate− standing(N=9,14,1): 12:00h	97.8 ( 12.4 )	81.2 ( 12.3 )	86 ( 99999 )
Pulse rate− standing(N=9,14,1): 24:00h	90 ( 18.8 )	85.8 ( 6.7 )	86 ( 99999 )

Notes
[68] - Safety Set
[69] - Safety Set
[70] - Safety Set

No statistical analyses for this end point

Adverse events

Top of page

Timeframe for reporting adverse events

From first drug administration until 24 hours after last study drug administration, upto 48 days

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

10.1

Reporting group title

PPX (MIRAPEX®, 0.125 mg)

Reporting group description

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.

Reporting group title

PPX (MIRAPEX®, 0.5 mg)

Reporting group description

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.

Reporting group title

PPX (MIRAPEX®, 0.25 mg)

Reporting group description

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.

Serious adverse events	PPX (MIRAPEX®, 0.125 mg)	PPX (MIRAPEX®, 0.5 mg)	PPX (MIRAPEX®, 0.25 mg)
Total subjects affected by serious adverse events
subjects affected / exposed	0 / 9 (0.00%)	0 / 2 (0.00%)	0 / 15 (0.00%)
number of deaths (all causes)	0	0	0
number of deaths resulting from adverse events	0	0	0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	PPX (MIRAPEX®, 0.125 mg)	PPX (MIRAPEX®, 0.5 mg)	PPX (MIRAPEX®, 0.25 mg)
Total subjects affected by non serious adverse events
subjects affected / exposed	2 / 9 (22.22%)	1 / 2 (50.00%)	3 / 15 (20.00%)
General disorders and administration site conditions
Fatigue
subjects affected / exposed	1 / 9 (11.11%)	0 / 2 (0.00%)	0 / 15 (0.00%)
occurrences all number	1	0	0
Infusion site erythema
subjects affected / exposed	0 / 9 (0.00%)	0 / 2 (0.00%)	1 / 15 (6.67%)
occurrences all number	0	0	1
Infusion site irritation
subjects affected / exposed	0 / 9 (0.00%)	0 / 2 (0.00%)	1 / 15 (6.67%)
occurrences all number	0	0	1
Infusion site pain
subjects affected / exposed	0 / 9 (0.00%)	0 / 2 (0.00%)	1 / 15 (6.67%)
occurrences all number	0	0	1
Vessel puncture site erythema
subjects affected / exposed	0 / 9 (0.00%)	0 / 2 (0.00%)	1 / 15 (6.67%)
occurrences all number	0	0	1
Vessel puncture site pain
subjects affected / exposed	0 / 9 (0.00%)	0 / 2 (0.00%)	1 / 15 (6.67%)
occurrences all number	0	0	1
Gastrointestinal disorders
Nausea
subjects affected / exposed	0 / 9 (0.00%)	1 / 2 (50.00%)	0 / 15 (0.00%)
occurrences all number	0	1	0
Vomiting
subjects affected / exposed	0 / 9 (0.00%)	1 / 2 (50.00%)	1 / 15 (6.67%)
occurrences all number	0	1	1
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	1 / 9 (11.11%)	0 / 2 (0.00%)	0 / 15 (0.00%)
occurrences all number	1	0	0

More information

Top of page

Were there any global substantial amendments to the protocol? No

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

A "Missing" category is unavailable for the country wise and age group breakdown of enrolled patients. Hence, 3 subjects with a missing age group have been added to "Children (2-11 years)".

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Cmax,ss

Primary: Cmax,ss

Primary: Cmin,ss

Primary: Cmin,ss

Primary: Cpre,N

Primary: Cpre,N

Primary: Cavg

Primary: Cavg

Primary: tmax,ss

Primary: tmax,ss

Primary: tmin,ss

Primary: tmin,ss

Primary: AUCτ,ss

Primary: AUCτ,ss

Primary: λz,ss

Primary: λz,ss

Primary: t1/2,ss

Primary: t1/2,ss

Primary: MRTpo,ss

Primary: MRTpo,ss

Primary: CL/F,ss

Primary: CL/F,ss

Primary: Vz/F,ss

Primary: Vz/F,ss

Primary: Ae 0-12,ss

Primary: Ae 0-12,ss

Primary: fe 0-12,ss

Primary: fe 0-12,ss

Primary: CLR 0-12,ss

Primary: CLR 0-12,ss

Primary: PTF

Primary: PTF

Secondary: Number of patients with drug related adverse events

Secondary: Number of patients with drug related adverse events

Secondary: Vital Signs (Systolic and Diastolic Blood Pressure)

Secondary: Vital Signs (Systolic and Diastolic Blood Pressure)

Secondary: Vital Signs (Pulse Rate)

Secondary: Vital Signs (Pulse Rate)

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information