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 |
|
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
|
|||
Trial identification
|
|||
Sponsor protocol code |
248.600
|
||
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
NCT02231918 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
|
|||
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
|
||
Paediatric regulatory details
|
|||
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? |
No
|
||
Results analysis stage
|
|||
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? |
No
|
||
General information about the trial
|
|||
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 |
No
|
||
Independent data monitoring committee (IDMC) involvement? |
No
|
||
Population of trial subjects
|
|||
Number of subjects enrolled per country |
|||
Country: Number of subjects enrolled |
United States: 35
|
||
Worldwide total number of subjects |
35
|
||
EEA total number of subjects |
0
|
||
Number of subjects enrolled per age group |
|||
In utero |
0
|
||
Preterm newborn - gestational age < 37 wk |
0
|
||
Newborns (0-27 days) |
0
|
||
Infants and toddlers (28 days-23 months) |
0
|
||
Children (2-11 years) |
20
|
||
Adolescents (12-17 years) |
15
|
||
Adults (18-64 years) |
0
|
||
From 65 to 84 years |
0
|
||
85 years and over |
0
|
|
|||||||||||||||||||||||||
Recruitment
|
|||||||||||||||||||||||||
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. | ||||||||||||||||||||||||
Pre-assignment
|
|||||||||||||||||||||||||
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
|
|||||||||||||||||||||||||
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.
|
||||||||||||||||||||||||
Arms
|
|||||||||||||||||||||||||
Are arms mutually exclusive |
Yes
|
||||||||||||||||||||||||
Arm title
|
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.
|
||||||||||||||||||||||||
Arm title
|
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.
|
||||||||||||||||||||||||
Arm title
|
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.
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
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 reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||
End points reporting groups
|
|||
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. |
|
|||||||||||||||||||||||||
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. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
Notes [2] - Pharmacokinetic Set (PKS) [3] - Pharmacokinetic Set (PKS) [4] - Pharmacokinetic Set (PKS) |
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
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. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
Notes [6] - Pharmacokinetic Set (PKS) [7] - Pharmacokinetic Set (PKS) [8] - Pharmacokinetic Set (PKS) |
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
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. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
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 |
|
|||||||||||||||||||||||||
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. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
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 |
|
|||||||||||||||||||||||||
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. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
Notes [18] - Pharmacokinetic Set (PKS) [19] - Pharmacokinetic Set (PKS) [20] - Pharmacokinetic Set (PKS) |
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
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. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
Notes [22] - Pharmacokinetic Set (PKS) [23] - Pharmacokinetic Set (PKS) [24] - Pharmacokinetic Set (PKS) |
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
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. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
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 |
|
|||||||||||||||||||||||||
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. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
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 |
|
|||||||||||||||||||||||||
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. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
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 |
|
|||||||||||||||||||||||||
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. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
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 |
|
|||||||||||||||||||||||||
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. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
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 |
|
|||||||||||||||||||||||||
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. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
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 |
|
|||||||||||||||||||||||||
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. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
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 |
|
|||||||||||||||||||||||||
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. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
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 |
|
|||||||||||||||||||||||||
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. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
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 |
|
|||||||||||||||||||||||||
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. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
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 |
|
|||||||||||||
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
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Notes [65] - Safety Set [66] - Safety Set [67] - Safety Set |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Notes [68] - Safety Set [69] - Safety Set [70] - Safety Set |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse events information
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
From first drug administration until 24 hours after last study drug administration, upto 48 days
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
10.1
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||
Substantial protocol amendments (globally) |
|||
Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
|||
Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
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)". |