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Assessment of the Safety and Efficacy of Pramipexole Extended Release in Patients With Parkinson's Disease in Routine Clinical Practice

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ClinicalTrials.gov Identifier: NCT01061567
Recruitment Status : Completed
First Posted : February 3, 2010
Results First Posted : July 8, 2014
Last Update Posted : July 8, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Parkinson's Disease
Enrollment 1814
Recruitment Details  
Pre-assignment Details  
Arm/Group Title All Patients
Hide Arm/Group Description Patients with Parkinson’s disease in routine clinical practice.
Period Title: Overall Study
Started 1814
Completed 1738
Not Completed 76
Reason Not Completed
Adverse Event             32
Death             2
Lack of Efficacy             3
Lost to Follow-up             24
Protocol Violation             1
Withdrawal by Subject             11
Other reason than stated above             3
Arm/Group Title All Patients
Hide Arm/Group Description Patients with Parkinson’s disease in routine clinical practice.
Overall Number of Baseline Participants 1814
Hide Baseline Analysis Population Description
Patients from Treated Set (TS) who were documented to have taken at least one dose of study treatment.
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1814 participants
68.8  (9.2)
[1]
Measure Description: For 19 patients no data for age was documented, so the age was available for N=1795 patients
Gender   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1814 participants
Female 910
Male 889
[1]
Measure Description: The documentation of gender was missing for 15 patients.
1.Primary Outcome
Title Incidence of Adverse Events
Hide Description The number of patients with any adverse events (AEs), patients with drug-related AEs.
Time Frame From the treatment initiation to the end of study, on average 92.9 days
Hide Outcome Measure Data
Hide Analysis Population Description
Patients from the Treated Set (TS).
Arm/Group Title All Patients
Hide Arm/Group Description:
Patients with Parkinson’s disease in routine clinical practice.
Overall Number of Participants Analyzed 1814
Measure Type: Number
Unit of Measure: participants
Patients with any AE 105
Patients with drug-related AEs 56
2.Primary Outcome
Title Proportion of Patients With Withdrawals Due to Adverse Events.
Hide Description Patients who discontinued treatment due to adverse events including deaths.
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Patients from the Treated Set (TS).
Arm/Group Title All Patients
Hide Arm/Group Description:
Patients with Parkinson’s disease in routine clinical practice.
Overall Number of Participants Analyzed 1814
Measure Type: Number
Unit of Measure: proportion of participants
0.019
3.Secondary Outcome
Title Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Parts I and III Total Score
Hide Description Mentation, behaviour and mood is scored from 0-16 in UPDRS I (0 = best score to 16 = worst score), result of motor examination scored from 0-108 in UPDRS III (0=no disability, 108=maximum disability) . The change was calculated by Baseline value minus value at visit 3. A decrease (change>0) in the score means improvement.
Time Frame Baseline and the end of study (up to 16 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Patients from the Full Analysis Set (FAS) which includes all treated patients who have data for at least one post baseline visit.
Arm/Group Title All Patients
Hide Arm/Group Description:
Patients with Parkinson’s disease in routine clinical practice.
Overall Number of Participants Analyzed 1807
Mean (Standard Deviation)
Unit of Measure: units on a scale
UPDRS Part I score (N=1756) 1.1  (1.6)
UPDRS Part III score (N=1670) 10.6  (9.4)
4.Secondary Outcome
Title Clinical Global Impression of Improvement (CGI-I) Responder Rate
Hide Description The CGI-I was rated (from 1: very much improved, to 7: very much worse) to assess the overall status of Parkinson’s disease. The clinician rated how much a patient’s condition had improved or worsened relative to baseline state. The patients are considered to be a CGI-I responder if they are rated at least by minimally improved.
Time Frame Baseline and the end of study (up to 16 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Patients from FAS
Arm/Group Title All Patients
Hide Arm/Group Description:
Patients with Parkinson’s disease in routine clinical practice.
Overall Number of Participants Analyzed 1807
Measure Type: Number
Unit of Measure: percentage of participants
84.3
5.Secondary Outcome
Title Change From Baseline in Visual Analogue Scale (VAS) of Patient Satisfaction
Hide Description The visual analogue scale measures overall patient satisfaction with treatment on a continuous axis ranging from 0 (no satisfaction) to 100 (highest patient satisfaction). The change was calculated by the value at the final visit minus the value at baseline. Therefore, an increase (change>0) reflects an improvement in patient satisfaction.
Time Frame Baseline and the end of study (up to 16 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Patients from FAS with evaluable data in VAS at baseline and at visit 3.
Arm/Group Title All Patients
Hide Arm/Group Description:
Patients with Parkinson’s disease in routine clinical practice.
Overall Number of Participants Analyzed 1657
Mean (Standard Deviation)
Unit of Measure: units on a scale
18.5  (22.6)
6.Secondary Outcome
Title Change From Baseline in Morisky Medication Adherence Scale (MMAS) 4 Item Score
Hide Description The Morisky Medication Adherence Scale with 4 items was administered to examine medication adherence. The score ranges from 0 (best adherence) to 4 (worst adherence). The change was calculated by the value at baseline minus the value at visit 3. Therefore, a change >0 reflects an improvement
Time Frame Baseline and the end of study (up to 16 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Patients from FAS with evaluable data in the Morisky scale for baseline and at visit 3.
Arm/Group Title All Patients
Hide Arm/Group Description:
Patients with Parkinson’s disease in routine clinical practice.
Overall Number of Participants Analyzed 1629
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.6  (1.1)
Time Frame From the treatment initiation to the end of study, on average 92.9 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Patients
Hide Arm/Group Description Patients with Parkinson’s disease in routine clinical practice.
All-Cause Mortality
All Patients
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
All Patients
Affected / at Risk (%)
Total   4/1814 (0.22%) 
Nervous system disorders   
Cerebral insult  1  1/1814 (0.06%) 
Psychiatric disorders   
Gambling  1  1/1814 (0.06%) 
Respiratory, thoracic and mediastinal disorders   
Aspiration  1  1/1814 (0.06%) 
Vascular disorders   
Heart failure  1  1/1814 (0.06%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MEDDRA 16.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
All Patients
Affected / at Risk (%)
Total   0/1814 (0.00%) 
There was no PI assigned for the overall study.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
EMail: clintriage.rdg@boehringer-ingelheim.com
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01061567     History of Changes
Other Study ID Numbers: 248.675
First Submitted: December 24, 2009
First Posted: February 3, 2010
Results First Submitted: June 6, 2014
Results First Posted: July 8, 2014
Last Update Posted: July 8, 2014