Pramipexole Versus Placebo in PD Patients With Depressive Symptoms

This study has been completed.

Sponsor:

Information provided by:

Boehringer Ingelheim Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00297778

First received: February 28, 2006

Last updated: May 18, 2012

Last verified: May 2012

History of Changes

Results First Received: May 22, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double-Blind; Primary Purpose: Treatment
Conditions:	Parkinson Disease Depression
Interventions:	Drug: Pramipexole Other: Placebo

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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Placebo	No text entered.
Pramipexole	No text entered.

Participant Flow: Overall Study

	Placebo	Pramipexole
STARTED	152	144
COMPLETED	133	124
NOT COMPLETED	19	20
Adverse Event	16	10
Withdrawal by Subject	1	5
Lack of Efficacy	2	1
Non-compliant with trial protocol	0	4

Baseline Characteristics

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Reporting Groups

	Description
Placebo	No text entered.
Pramipexole	No text entered.
Total	Total of all reporting groups

Baseline Measures

	Placebo	Pramipexole	Total
Number of Participants [units: participants]	152	144	296
Age [units: Years] Mean ± Standard Deviation	66.6 ± 9.9	67.4 ± 9.0	67 ± 9.5
Gender [units: participants]
Female	74	82	156
Male	78	62	140

Outcome Measures

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1. Primary:

Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Week 12 [ Time Frame: Baseline and Week 12 ]

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2. Secondary:

BDI-IA Clinical Response at Week 12 [ Time Frame: Week 12 ]

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3. Secondary:

Change From Baseline in the Geriatric Depression Scale-Short Form (GDS-SF) Total Score at Week 12 [ Time Frame: Baseline and Week 12 ]

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4. Secondary:

Change From Baseline in Snaith-Hamilton Pleasure Scale (SHAPS) Total Score at Week 12 [ Time Frame: Baseline and Week 12 ]

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5. Secondary:

Change From Baseline in the Unified Parkinson's Disease Rating Scale (UPDRS) Part I Depression Score at Week 12 [ Time Frame: Baseline and Week 12 ]

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6. Secondary:

Change From Baseline in the UPDRS Part II Total Score at Week 12 [ Time Frame: Baseline and Week 12 ]

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Measure Type	Secondary
Measure Title	Change From Baseline in the UPDRS Part II Total Score at Week 12
Measure Description	Unified Parkinson's Disease Rating Scale part II total score on FAS The UPDRS part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (normal) to 52 (worst symptoms)
Time Frame	Baseline and Week 12
Safety Issue

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS. 9 participants from those randomised and treated were excluded due to insufficient UPDRS data.

Reporting Groups

	Description
Placebo	No text entered.
Pramipexole	No text entered.

Measured Values

	Placebo	Pramipexole
Number of Participants Analyzed [units: participants]	148	139
Change From Baseline in the UPDRS Part II Total Score at Week 12 [units: units on a scale] Least Squares Mean ± Standard Error	-1.2 ± 0.3	-2.4 ± 0.3

Statistical Analysis 1 for Change From Baseline in the UPDRS Part II Total Score at Week 12

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.003
Mean Difference (Net) ^[4]	-1.2
95% Confidence Interval	( -1.9 to -0.4 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
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[2]	Other relevant information, such as adjustments or degrees of freedom:
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[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
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[4]	Other relevant estimation information:
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7. Secondary:

Change From Baseline in the UPDRS Part III Total Score at Week 12 [ Time Frame: Baseline and Week 12 ]

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8. Secondary:

Change From Baseline in the UPDRS Part II+III Total Score at Week 12 [ Time Frame: Baseline and Week 12 ]

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9. Secondary:

Clinical Global Impressions of Global Improvement (CGI-I) at Week 12 [ Time Frame: Week 12 ]

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10. Secondary:

Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Week 12 [ Time Frame: Baseline and Week 12 ]

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11. Secondary:

Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Week 12 [ Time Frame: Baseline and Week 12 ]

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12. Secondary:

Change From Baseline in the European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Score at Week 12 [ Time Frame: Baseline and Week 12 ]

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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
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Results Point of Contact:

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

No publications provided by Boehringer Ingelheim Pharmaceuticals

Publications automatically indexed to this study:

Bxarone P, Poewe W, Albrecht S, Debieuvre C, Massey D, Rascol O, Tolosa E, Weintraub D. Pramipexole for the treatment of depressive symptoms in patients with Parkinson's disease: a randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2010 Jun;9(6):573-80. Epub 2010 May 7.

Responsible Party:	Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier:	NCT00297778 History of Changes
Other Study ID Numbers:	248.596, Eudract 2005-003788-22
Study First Received:	February 28, 2006
Results First Received:	May 22, 2009
Last Updated:	May 18, 2012
Health Authority:	Austria: Federal Office for Safety in Health Care Finland: Finnish Medicines Agency France: Afssaps Germany: Ethikkommission bei der Landesaerztekammer Baden-Wuerttemberg Italy: Comitato Etico Ospedale Civile S. Spirito, Università "G. D'Annunzio" Netherlands: Medish Etische toetsingscommissie Atrium MC Norway: Norwegian Medicines Agency (Statens Legemiddelverk) Romania: National Medicines Agency, Bucharest Russia: Ministry of Healthcare and Social Development of Russian Federation, Moscow South Africa: Medicines Council Country Spain: Unidad de Registro y Tasas, Agencia Espanola del medicamento y productos sanitarios Sweden: Medical Products Agency Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine)

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