Clinical Trial Results:
An open-label, flexible dose, follow-up study to evaluate safety and efficacy of oral pramipexole (0.0625-0.5 mg/day) for 24 weeks in
children and adolescents (age 6-17 years) diagnosed with Tourette Syndrome according to DSM-IV criteria and who have completed the
double-blind phase of either study 248.641 or 248.644.
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Summary
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EudraCT number |
2008-000342-32 |
Trial protocol |
DE Outside EU/EEA |
Global end of trial date |
15 Oct 2009
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Results information
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Results version number |
v1(current) |
This version publication date |
20 Jun 2016
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First version publication date |
16 Jul 2015
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
248.642
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT00681863 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Boehringer Ingelheim
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Sponsor organisation address |
Binger Strasse 173, 55216 Ingelheim am Rhein, Germany,
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Public contact |
Boehringer Ingelheim
Pharma GmbH & Co KG, QRPE Processes and Systems Coordination
Clinical Trial Information Disclosure
, +1 8002430127, clintriage.rdg@boehringer-ingelheim.com
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Scientific contact |
Boehringer Ingelheim
Pharma GmbH & Co KG, QRPE Processes and Systems Coordination
Clinical Trial Information Disclosure
, +1 8002430127, clintriage.rdg@boehringer-ingelheim.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
Yes
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EMA paediatric investigation plan number(s) |
EMEA-000041-PIP01-07 | ||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
24 Nov 2009
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
15 Oct 2009
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
The primary objective of this open-label, flexible dose study is to assess the safety and efficacy of pramipexole over a 24-week period in children and adolescents (age 6-17 years inclusive) diagnosed with Tourette Syndrome according to DSM-IV criteria and who have completed either Study 248.641 or 248.644.
The safety of pramipexole will be evaluated collectively for the incidence of adverse events, the proportion of withdrawals due to drug related adverse events, and the assessment of the following scales:
• Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS);
• Child Behavior Checklist (CBCL) ;
• DuPaul Attention-Deficit / Hyperactivity Disorder (ADHD) Rating Scale-IV;
• Child Depression Inventory-Short Version CDI-S;
• Multidimensional Anxiety Scale for Children (MASC).
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Protection of trial subjects |
Only subjects that met all the study inclusion and none of the exclusion criteria were 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.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
23 May 2008
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Germany: 2
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Country: Number of subjects enrolled |
United States: 44
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Worldwide total number of subjects |
46
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EEA total number of subjects |
2
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
21
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Adolescents (12-17 years) |
25
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
46 participants were enrolled in the trial. Out of these enrolled participants, 1 participant did not enter the trial. | ||||||||||||||||
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Pre-assignment
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Screening details |
All subjects were screened for eligibility to participate in the trial. Subjects attended specialist sites which would then ensure that the subject met all strictly implemented inclusion/exclusion criteria. Patients with Tourette Syndrome who have completed the preceding Study 248.641 or 248.644 were assessed for entry into this rollover study. | ||||||||||||||||
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Period 1
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Period 1 title |
Treatment period (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||
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Arms
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Arm title
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Pramipexole | ||||||||||||||||
Arm description |
4 weeks individual dose titration starting with 0.0625 mg BID (twice daily), down-titration to 0.0625 QD (once daily) if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID (three times daily) and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period. | ||||||||||||||||
Arm type |
Experimental | ||||||||||||||||
Investigational medicinal product name |
Mirapex®, Mirapexin®, Sifrol®, Pexola®
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
4 weeks individual dose titration starting with 0.0625 mg BID (twice daily), down-titration to 0.0625 QD (once daily) if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID (three times daily) and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
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Baseline characteristics reporting groups [1]
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Reporting group title |
Pramipexole
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Reporting group description |
4 weeks individual dose titration starting with 0.0625 mg BID (twice daily), down-titration to 0.0625 QD (once daily) if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID (three times daily) and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Notes [1] - The number of subjects reported to be in the baseline period is not equal to the worldwide number of subjects 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. |
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End points reporting groups
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Reporting group title |
Pramipexole
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Reporting group description |
4 weeks individual dose titration starting with 0.0625 mg BID (twice daily), down-titration to 0.0625 QD (once daily) if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID (three times daily) and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period. | ||
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End point title |
Patients with Adverse Events leading to discontinuation of trial drug [1] | ||||||
End point description |
Number of patients with Adverse Events leading to discontinuation of trial drug.
The Treated Set (TS) included all patients who were entered, dispensed study medication and were documented to have taken at least one dose of study medication. This data set, used to summarise the safety results, included all 45 patients that were entered in this trial.
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End point type |
Primary
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End point timeframe |
24 Weeks
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| 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. |
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| Notes [2] - Treated set |
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| No statistical analyses for this end point | |||||||
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End point title |
Mean change from baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale at End of treatment visit | ||||||||
End point description |
Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50.
The Full Analysis Set (FAS) included all patients who were included in the treated set and have both a baseline and at least one post-treatment TTS value. This data set, used to summarise the efficacy results, included all 45 patients that were entered and treated in this trial.
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End point type |
Secondary
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End point timeframe |
baseline and End of treatment visit (week 24)
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| Notes [3] - FAS |
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| No statistical analyses for this end point | |||||||||
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End point title |
Mean change from baseline in Total Score of the Yale Global Tic Severity Scale at the end of treatment visit | ||||||||
End point description |
Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe).
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End point type |
Secondary
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End point timeframe |
baseline and end of treatment visit
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| Notes [4] - FAS |
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| No statistical analyses for this end point | |||||||||
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End point title |
Mean change from baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale at week 1 | ||||||||
End point description |
Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50.
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End point type |
Secondary
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End point timeframe |
baseline and Week 1
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| Notes [5] - FAS |
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| No statistical analyses for this end point | |||||||||
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End point title |
Mean change from baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale at week 2 | ||||||||
End point description |
Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50.
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End point type |
Secondary
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End point timeframe |
baseline and Week 2
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| Notes [6] - FAS |
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| No statistical analyses for this end point | |||||||||
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End point title |
Mean change from baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale at week 3 | ||||||||
End point description |
Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50.
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End point type |
Secondary
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End point timeframe |
baseline and Week 3
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| Notes [7] - FAS(Only patients with baseline and week 3 values were analysed) |
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| No statistical analyses for this end point | |||||||||
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End point title |
Mean change from baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale at week 4 | ||||||||
End point description |
Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50.
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End point type |
Secondary
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End point timeframe |
baseline and week 4
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| Notes [8] - FAS (Only patients with baseline and week 4 values were analysed) |
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| No statistical analyses for this end point | |||||||||
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End point title |
Mean change from baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale at week 8 | ||||||||
End point description |
Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50.
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End point type |
Secondary
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End point timeframe |
baseline and Week 8
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| Notes [9] - FAS (Only patients with baseline and week 8 values were analysed) |
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| No statistical analyses for this end point | |||||||||
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End point title |
Mean change from baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale at week 12 | ||||||||
End point description |
Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50.
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End point type |
Secondary
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End point timeframe |
baseline and Week 12
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| Notes [10] - FAS (Only patients with baseline and week 12 values were analysed) |
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| No statistical analyses for this end point | |||||||||
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End point title |
Mean change from baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale at week 16 | ||||||||
End point description |
Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50.
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End point type |
Secondary
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End point timeframe |
baseline and Week 16
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| Notes [11] - FAS (Only patients with baseline and week 16 values were analysed) |
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| No statistical analyses for this end point | |||||||||
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End point title |
Mean change from baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale at week 20 | ||||||||
End point description |
Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50.
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End point type |
Secondary
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End point timeframe |
baseline and Week 20
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| Notes [12] - FAS (Only patients with baseline and week 20 values were analysed) |
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| No statistical analyses for this end point | |||||||||
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End point title |
Mean change from baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale at week 24 | ||||||||
End point description |
Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50.
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End point type |
Secondary
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End point timeframe |
baseline and Week 24
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| Notes [13] - FAS (Only patients with baseline and week 24 values were analysed) |
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| No statistical analyses for this end point | |||||||||
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End point title |
Mean change from baseline in Total Score of the Yale Global Tic Severity Scale at week 1 | ||||||||
End point description |
Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe).
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End point type |
Secondary
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End point timeframe |
baseline and Week 1
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| Notes [14] - FAS |
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| No statistical analyses for this end point | |||||||||
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End point title |
Mean change from baseline in Total Score of the Yale Global Tic Severity Scale at week 2 | ||||||||
End point description |
Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe).
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End point type |
Secondary
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End point timeframe |
baseline and Week 2
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| Notes [15] - FAS |
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| No statistical analyses for this end point | |||||||||
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End point title |
Mean change from baseline in Total Score of the Yale Global Tic Severity Scale at week 3 | ||||||||
End point description |
Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe).
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End point type |
Secondary
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End point timeframe |
baseline and Week 3
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| Notes [16] - FAS (Only patients with baseline and week 3 values were analysed) |
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| No statistical analyses for this end point | |||||||||
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End point title |
Mean change from baseline in Total Score of the Yale Global Tic Severity Scale at week 4 | ||||||||
End point description |
Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe).
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End point type |
Secondary
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End point timeframe |
baseline and Week 4
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| Notes [17] - FAS (Only patients with baseline and week 4 values were analysed) |
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| No statistical analyses for this end point | |||||||||
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End point title |
Mean change from baseline in Total Score of the Yale Global Tic Severity Scale at week 8 | ||||||||
End point description |
Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe).
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End point type |
Secondary
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End point timeframe |
baseline and Week 8
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| Notes [18] - FAS (Only patients with baseline and week 8 values were analysed) |
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| No statistical analyses for this end point | |||||||||
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End point title |
Mean change from baseline in Total Score of the Yale Global Tic Severity Scale at week 12 | ||||||||
End point description |
Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe).
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End point type |
Secondary
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End point timeframe |
baseline and Week 12
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| Notes [19] - FAS (Only patients with baseline and week 12 values were analysed) |
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| No statistical analyses for this end point | |||||||||
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End point title |
Mean change from baseline in Total Score of the Yale Global Tic Severity Scale at week 16 | ||||||||
End point description |
Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe).
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End point type |
Secondary
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End point timeframe |
baseline and Week 16
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| Notes [20] - FAS (Only patients with baseline and week 16 values were analysed) |
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| No statistical analyses for this end point | |||||||||
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End point title |
Mean change from baseline in Total Score of the Yale Global Tic Severity Scale at week 20 | ||||||||
End point description |
Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe).
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End point type |
Secondary
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End point timeframe |
baseline and Week 20
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| Notes [21] - FAS (Only patients with baseline and week 20 values were analysed) |
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| No statistical analyses for this end point | |||||||||
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End point title |
Mean change from baseline in Total Score of the Yale Global Tic Severity Scale at week 24 | ||||||||
End point description |
Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe).
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End point type |
Secondary
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End point timeframe |
baseline and Week 24
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| Notes [22] - FAS (Only patients with baseline and week 24 values were analysed) |
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| No statistical analyses for this end point | |||||||||
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End point title |
Clinical Global Impressions - Severity of Illness, Categorized at week 24 | ||||||||||||
End point description |
Assessment of the overall severity of illness on a scale ranging from 1 (not at all ill) to 7 (among the most extremely ill patients). Overall improvement during the last week compared to baseline ranging from 1 (very much improved), 2 (much improved), to 7 (very much worse). Responder has 'very much' or 'much' improvement. Non responder has less improvement than 'much' improvement.
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End point type |
Secondary
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End point timeframe |
week 24
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| Notes [23] - FAS (Only patients with baseline and week 24 values were analysed) |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Clinical Global Impressions - Severity of Illness at week 24 | ||||||||
End point description |
Overall improvement during the last week compared to baseline ranging from 1 (very much improved), 2 (much improved), to 7 (very much worse). Responder has 'very much' or 'much' improvement. Non responder has less improvement than 'much' improvement.
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End point type |
Secondary
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End point timeframe |
week 24
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| Notes [24] - FAS (Only patients with baseline and week 24 values were analysed |
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| No statistical analyses for this end point | |||||||||
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End point title |
Clinical Global Impressions - Improvement at week 2 | ||||||
End point description |
Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse).
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End point type |
Secondary
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End point timeframe |
week 2
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| Notes [25] - Outcome measure was not analyzed due to the premature ending of the trial (0 participants analyzed) |
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| No statistical analyses for this end point | |||||||
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End point title |
Clinical Global Impressions - Improvement at week 1 | ||||||
End point description |
Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse).
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End point type |
Secondary
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End point timeframe |
week 1
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| Notes [26] - Outcome measure was not analyzed due to the premature ending of the trial (0 participants analyzed) |
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| No statistical analyses for this end point | |||||||
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End point title |
Clinical Global Impressions - Improvement at week 3 | ||||||
End point description |
Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse).
|
||||||
End point type |
Secondary
|
||||||
End point timeframe |
week 3
|
||||||
|
|||||||
| Notes [27] - Outcome measure was not analyzed due to the premature ending of the trial (0 participants analyzed) |
|||||||
| No statistical analyses for this end point | |||||||
|
|||||||
End point title |
Clinical Global Impressions - Improvement at week 4 | ||||||
End point description |
Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse).
|
||||||
End point type |
Secondary
|
||||||
End point timeframe |
week 4
|
||||||
|
|||||||
| Notes [28] - Outcome measure was not analyzed due to the premature ending of the trial (0 participants analyzed) |
|||||||
| No statistical analyses for this end point | |||||||
|
|||||||
End point title |
Clinical Global Impressions - Improvement at week 8 | ||||||
End point description |
Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse).
|
||||||
End point type |
Secondary
|
||||||
End point timeframe |
week 8
|
||||||
|
|||||||
| Notes [29] - Outcome measure was not analyzed due to the premature ending of the trial (0 participants analyzed) |
|||||||
| No statistical analyses for this end point | |||||||
|
|||||||
End point title |
Clinical Global Impressions - Improvement at week 16 | ||||||
End point description |
Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse).
|
||||||
End point type |
Secondary
|
||||||
End point timeframe |
week 16
|
||||||
|
|||||||
| Notes [30] - Outcome measure was not analyzed due to the premature ending of the trial (0 participants analyzed) |
|||||||
| No statistical analyses for this end point | |||||||
|
|||||||
End point title |
Clinical Global Impressions - Improvement at week 12 | ||||||
End point description |
Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse).
|
||||||
End point type |
Secondary
|
||||||
End point timeframe |
week 12
|
||||||
|
|||||||
| Notes [31] - Outcome measure was not analyzed due to the premature ending of the trial (0 participants analyzed) |
|||||||
| No statistical analyses for this end point | |||||||
|
|||||||
End point title |
Clinical Global Impressions - Improvement at week 20 | ||||||
End point description |
Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse).
|
||||||
End point type |
Secondary
|
||||||
End point timeframe |
week 20
|
||||||
|
|||||||
| Notes [32] - Outcome measure was not analyzed due to the premature ending of the trial (0 participants analyzed) |
|||||||
| No statistical analyses for this end point | |||||||
|
|||||||||||
End point title |
Clinical Global Impressions - Improvement at week 24 | ||||||||||
End point description |
Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse).
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
week 24
|
||||||||||
|
|||||||||||
| Notes [33] - FAS |
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||
End point title |
Patient Global Impression - Improvement at week 1 | ||||||
End point description |
Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).
|
||||||
End point type |
Secondary
|
||||||
End point timeframe |
week 1
|
||||||
|
|||||||
| Notes [34] - Outcome measure was not analyzed due to the premature ending of the trial (0 participants analyzed) |
|||||||
| No statistical analyses for this end point | |||||||
|
|||||||
End point title |
Patient Global Impression - Improvement at week 2 | ||||||
End point description |
Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).
|
||||||
End point type |
Secondary
|
||||||
End point timeframe |
week 2
|
||||||
|
|||||||
| Notes [35] - Outcome measure was not analyzed due to the premature ending of the trial (0 participants analyzed) |
|||||||
| No statistical analyses for this end point | |||||||
|
|||||||
End point title |
Patient Global Impression - Improvement at week 3 | ||||||
End point description |
Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).
|
||||||
End point type |
Secondary
|
||||||
End point timeframe |
week 3
|
||||||
|
|||||||
| Notes [36] - Outcome measure was not analyzed due to the premature ending of the trial (0 participants analyzed) |
|||||||
| No statistical analyses for this end point | |||||||
|
|||||||
End point title |
Patient Global Impression - Improvement at week 4 | ||||||
End point description |
Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).
|
||||||
End point type |
Secondary
|
||||||
End point timeframe |
week 4
|
||||||
|
|||||||
| Notes [37] - Outcome measure was not analyzed due to the premature ending of the trial (0 participants analyzed) |
|||||||
| No statistical analyses for this end point | |||||||
|
|||||||
End point title |
Patient Global Impression - Improvement at week 8 | ||||||
End point description |
Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).
|
||||||
End point type |
Secondary
|
||||||
End point timeframe |
week 8
|
||||||
|
|||||||
| Notes [38] - Outcome measure was not analyzed due to the premature ending of the trial (0 participants analyzed) |
|||||||
| No statistical analyses for this end point | |||||||
|
|||||||
End point title |
Patient Global Impression - Improvement at week 12 | ||||||
End point description |
Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).
|
||||||
End point type |
Secondary
|
||||||
End point timeframe |
week 12
|
||||||
|
|||||||
| Notes [39] - Outcome measure was not analyzed due to the premature ending of the trial (0 participants analyzed) |
|||||||
| No statistical analyses for this end point | |||||||
|
|||||||
End point title |
Patient Global Impression - Improvement at week 16 | ||||||
End point description |
Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).
|
||||||
End point type |
Secondary
|
||||||
End point timeframe |
week 16
|
||||||
|
|||||||
| Notes [40] - Outcome measure was not analyzed due to the premature ending of the trial (0 participants analyzed) |
|||||||
| No statistical analyses for this end point | |||||||
|
|||||||
End point title |
Patient Global Impression - Improvement at week 20 | ||||||
End point description |
Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).
|
||||||
End point type |
Secondary
|
||||||
End point timeframe |
week 20
|
||||||
|
|||||||
| Notes [41] - Outcome measure was not analyzed due to the premature ending of the trial (0 participants analyzed) |
|||||||
| No statistical analyses for this end point | |||||||
|
|||||||||||
End point title |
Patient Global Impression - Improvement at week 24 | ||||||||||
End point description |
Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
week 24
|
||||||||||
|
|||||||||||
| Notes [42] - FAS |
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||||||
End point title |
Frequency of patients with possible clinically significant abnormalities for laboratory parameters | ||||||||||||||
End point description |
Clinical Relevant Abnormalities for laboratory parameters. Any new or clinically relevant worsening of baseline conditions was reported as Adverse Events.
The Treated Set (TS) included all patients who were entered, dispensed study medication and were documented to have taken at least one dose of study medication. This data set, used to summarise the safety results, included all 45 patients that were entered in this trial.
|
||||||||||||||
End point type |
Secondary
|
||||||||||||||
End point timeframe |
Baseline and 24 weeks
|
||||||||||||||
|
|||||||||||||||
| Notes [43] - TS (observed cases) |
|||||||||||||||
| No statistical analyses for this end point | |||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Adverse events information
|
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Timeframe for reporting adverse events |
From baseline up to the start date of follow-up period, up to 24 weeks
|
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Dictionary used for adverse event reporting
|
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
12.1
|
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|
Reporting groups
|
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Reporting group title |
Pramipexole
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||
Substantial protocol amendments (globally) |
|||||||
| Were there any global substantial amendments to the protocol? Yes | |||||||
Date |
Amendment |
||||||
05 Nov 2008 |
Extended the follow-up period after the end of treatment to optimize patient safety monitoring
• Addition of a phone visit (Visit 12) seven days after Visit 11
• Addition of Visit 13, the final visit, 28 days after Visit 11
• Utilization of a Data Monitoring Committee
• Current expected AE list should be obtained from the Investigator Brochure
• Decision to send study drug to sites in child resistant bottles, not blisters in the maintenance phase
• Clarification of:
- timing of the eye examination;
- duration of the down-titration phase;
- duration and on-study medication supply for down-titration phase;
- thyroid function parameters:
- age-appropriate range for serum creatinine |
||||||
05 May 2009 |
Study medication for the down-titration phase to only be supplied in child-resistant bottles |
||||||
Interruptions (globally) |
|||||||
| Were there any global interruptions to the trial? Yes | |||||||
|
|||||||
Limitations and caveats |
|||||||
| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||||||
| The sponsor cancelled this trial prematurely. Thus, enrollment for 248.642 (NCT00681863) was significantly less than what was planned (120 planned vs. 45 entered). Therefore, the objectives of this study could not be fully assessed. | |||||||
