Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

First Presentation of Parkinson Disease Patients to Neurologist

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00802178
Recruitment Status : Completed
First Posted : December 4, 2008
Results First Posted : November 20, 2009
Last Update Posted : April 11, 2014
Sponsor:
Information provided by:
Boehringer Ingelheim

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Parkinson Disease
Enrollment 2448
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Mirapexin® (Pramipexole)
Hide Arm/Group Description

The dose of Mirapexin® was selected by the neurologist upon his/her clinical judgement based on individual patient need and on recommendations given in the Mirapexin® Summary of Product Characteristics.

mode of administration (admin.): Tablets for oral use

Period Title: Overall Study
Started 2448
Completed 2335
Not Completed 113
Reason Not Completed
Lack of Efficacy             36
Insufficient tolerability (IT)             17
Withdrawal by Subject             18
Other             32
Lack of efficacy and patient wish             1
IT and patient wish             8
Patients wish and other reason             1
Arm/Group Title Mirapexin® (Pramipexole)
Hide Arm/Group Description The dose of Mirapexin® was selected by the neurologist upon his/her clinical judgement based on individual patient need and on recommendations given in the Mirapexin® Summary of Product Characteristics. mode of admin.: Tablets for oral use.
Overall Number of Baseline Participants 2448
Hide Baseline Analysis Population Description
Treated set (TS)
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 2448 participants
67.23
(31 to 97)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 2448 participants
Female 1145
Male 1274
missing 29
1.Primary Outcome
Title Number of De-novo Patients in Whom Monotherapy With Mirapexin® Could be Successfully Initiated
Hide Description

Successful initiation was defined as a clinical assessment of efficacy by the neurologist rated at least as “good” on a 4 point scale after 4-8 weeks Mirapexin® treatment, where:1 = very good; 2 = good; 3 = moderate; and 4 = poor.

De-novo patients were identified by:

those who were referred: - if ‘Reason for Referral’ = ‘initiation of therapy’ or for ‘diagnostic reason’ and for those not referred: - if initial pharmacotherapy = ‘Mirapexin® monotherapy’ (i.e., no other anti Parkinson Disease (PD) therapy)

Time Frame 4 - 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis set (FAS) of De-novo patients in whom monotherapy with Mirapexin® could be successfully initiated
Arm/Group Title Mirapexin® (Pramipexole)
Hide Arm/Group Description:
The dose of Mirapexin® was selected by the neurologist upon his/her clinical judgement based on individual patient need and on recommendations given in the Mirapexin® Summary of Product Characteristics. mode of admin.: Tablets for oral use.
Overall Number of Participants Analyzed 833
Measure Type: Number
Unit of Measure: Participants
Very good 403
Good 323
Moderate 73
Poor 15
Global Clinical Assessment (GCA) missing 19
2.Secondary Outcome
Title Change From Baseline in UPDRS (Unified Parkinson’s Disease Rating Scale) Part I
Hide Description Change in UPDRS Part I score from baseline to final visit. The score ranging from 0-16 (0= no disability, 16= maximum disability)
Time Frame Baseline and 4 to 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis set (FAS)
Arm/Group Title Mirapexin® (Pramipexole)
Hide Arm/Group Description:
The dose of Mirapexin® was selected by the neurologist upon his/her clinical judgement based on individual patient need and on recommendations given in the Mirapexin® Summary of Product Characteristics. mode of admin.: Tablets for oral use.
Overall Number of Participants Analyzed 2370
Measure Type: Number
Unit of Measure: Unit on a scale
-1.20
3.Secondary Outcome
Title Change From Baseline in UPDRS Part III
Hide Description Change in UPDRS Part III score from baseline to final visit. Score ranging from 0 - 108 (0= no disability, 108 = worst disability).
Time Frame Baseline and 4 - 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis set (FAS)
Arm/Group Title Mirapexin® (Pramipexole)
Hide Arm/Group Description:
The dose of Mirapexin® was selected by the neurologist upon his/her clinical judgement based on individual patient need and on recommendations given in the Mirapexin® Summary of Product Characteristics. mode of admin.: Tablets for oral use.
Overall Number of Participants Analyzed 2370
Measure Type: Number
Unit of Measure: Unit on a scale
-11.18
4.Secondary Outcome
Title Global Clinical Assessments of Efficacy of Mirapexin® for All Patients
Hide Description Successful initiation was defined as a clinical assessment of efficacy by the neurologist rated at least as “good” on a 4 point scale after 4-8 weeks Mirapexin® treatment, where:1 = very good; 2 = good; 3 = moderate; and 4 = poor.
Time Frame 4 - 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Treated set (TS)
Arm/Group Title Mirapexin® (Pramipexole)
Hide Arm/Group Description:
The dose of Mirapexin® was selected by the neurologist upon his/her clinical judgement based on individual patient need and on recommendations given in the Mirapexin® Summary of Product Characteristics. mode of admin.: Tablets for oral use.
Overall Number of Participants Analyzed 2448
Measure Type: Number
Unit of Measure: Number of Participants
Very good 1043
Good 1004
Moderate 263
Poor 55
Global Clinical Assessment (GCA) missing 83
Time Frame During 4 - 8 weeks of therapy
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Mirapexin® (Pramipexole)
Hide Arm/Group Description The dose of Mirapexin® was selected by the neurologist upon his/her clinical judgement based on individual patient need and on recommendations given in the Mirapexin® Summary of Product Characteristics. mode of admin.: Tablets for oral use.
All-Cause Mortality
Mirapexin® (Pramipexole)
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Mirapexin® (Pramipexole)
Affected / at Risk (%)
Total   0/2448 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Mirapexin® (Pramipexole)
Affected / at Risk (%)
Total   0/2448 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
Results Point of Contact
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00802178     History of Changes
Other Study ID Numbers: 248.613
First Submitted: December 3, 2008
First Posted: December 4, 2008
Results First Submitted: September 30, 2009
Results First Posted: November 20, 2009
Last Update Posted: April 11, 2014