Special Survey on PD Patients Treated Long-term Use of Pramipexole

This study has been completed.

Sponsor:

Information provided by:

Boehringer Ingelheim Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00615914

First received: January 31, 2008

Last updated: May 18, 2012

Last verified: May 2012

History of Changes

Results First Received: September 8, 2010

Study Type:	Observational
Study Design:	Observational Model: Cohort; Time Perspective: Prospective
Condition:	Parkinson Disease

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Pramipexole	The drug was administered orally to patients accrding to the package insert in Japan. The drug form is only tablet. The initial dose was 0.125 mg twice a day, and was escalated in case of lack of efficacy. The maintenance dose was between 1.5 mg/day and 4.5 mg/day (0.5 mg - 1.5 mg three times a day).

Participant Flow: Overall Study

	Pramipexole
STARTED	1645 ^[1]
COMPLETED	1008
NOT COMPLETED	637
Adverse Event	274
Death	20
Lack of Efficacy	59
Lost to Follow-up	187
Withdrawal by Subject	16
Physician Decision	4
No data was collected.	65
No treatment	2
Irreguarly enrolled patients	10

[1]	The number of patients enrolled

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Pramipexole	The number of patients enrolled was 1645. The number of case report form which were collected was 1581. Moreover the number of patients analyzed as safety analysis was 1553 because 28 patients were excluded due to protocol violations.

Baseline Measures

	Pramipexole
Number of Participants [units: participants]	1553
Age [units: years] Mean ± Standard Deviation	69.0 ± 8.9
Gender [units: participants]
Female	890
Male	663

Outcome Measures

Show All Outcome Measures

1. Primary:

Proportion of Adverse Events, Adverse Drug Reactions, Serious Adverse Events [ Time Frame: during 18 months ]

Show Outcome Measure 1

2. Secondary:

Clinical Global Impression of Improvement [ Time Frame: 18 months ]

Show Outcome Measure 2

3. Secondary:

Change From Baseline in UPDRS (Unified Parkinson's Disease Rating Scale) Part III Total Score [ Time Frame: Baseline and at 18 months (or at the time of discontinuation) ]

Show Outcome Measure 3

4. Secondary:

Change From Baseline in Modified Hoehn & Yahr Rating Scale [ Time Frame: Baseline and at 18 months (or at the time of discontinuation) ]

Show Outcome Measure 4

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

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.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com

No publications provided

Responsible Party:	Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier:	NCT00615914 History of Changes
Other Study ID Numbers:	248.547
Study First Received:	January 31, 2008
Results First Received:	September 8, 2010
Last Updated:	May 18, 2012
Health Authority:	Japan: Ministry of Health, Labor and Welfare

To Top