Influence of Pramipexole Extended Release on Medication Adherence in Parkinson´s Disease

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Boehringer Ingelheim Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT01097421

First received: March 25, 2010

Last updated: October 25, 2012

Last verified: October 2012

History of Changes

Results First Received: September 14, 2012

Study Type:	Observational
Study Design:	Observational Model: Cohort; Time Perspective: Prospective
Condition:	Parkinson Disease
Intervention:	Drug: Pramipexole Extended Release

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
There were 328 patients entered and treated with a documented baseline observation in this study.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
This was an open-label, prospective, non-controlled, non-interventional observational, post marketing surveillance study.

Reporting Groups

	Description
Pramipexole Extended Release	individual doses planned in the range of 0.26 mg (0.375 mg of salt) to 3.15 mg (4.5 mg of salt) of base per day

Participant Flow: Overall Study

	Pramipexole Extended Release
STARTED	328
COMPLETED	314
NOT COMPLETED	14
Adverse Event	8
Protocol Violation	2
Lost to Follow-up	1
Withdrawal by Subject	3

Baseline Characteristics

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Reporting Groups

	Description
Pramipexole Extended Release	individual doses planned in the range of 0.26 mg (0.375 mg of salt) to 3.15 mg (4.5 mg of salt) of base per day

Baseline Measures

	Pramipexole Extended Release
Number of Participants [units: participants]	326
Age [units: Years] Mean ± Standard Deviation	70.6 ± 9.5
Gender [units: Participants]
Female	116
Male	210

Outcome Measures

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1. Primary:

Patients With a Score of 4 in Morisky Scale After 8-12 Weeks of Treatment [ Time Frame: 8-12 weeks ]

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2. Primary:

Level of Adherence [ Time Frame: 8-12 weeks ]

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3. Secondary:

Patient Preference [ Time Frame: 8-12 weeks ]

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4. Secondary:

Adverse Events (AE) Considered Related to Observed Medication [ Time Frame: 8-12 weeks ]

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5. Secondary:

Pramipexole (PPX) Dose [ Time Frame: pre-treatment and after 8-12 weeks ]

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6. Secondary:

Clinical Global Impressions (CGI) [ Time Frame: 8-12 weeks ]

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7. Secondary:

Patients Global Impressions (PGI) [ Time Frame: 8-12 weeks ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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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 Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01097421 History of Changes
Other Study ID Numbers:	248.674
Study First Received:	March 25, 2010
Results First Received:	September 14, 2012
Last Updated:	October 25, 2012
Health Authority:	Sweden: Medical Products Agency

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