Efficacy, Safety, Tolerability of Pramipexol ER Versus Pramipexol IR Versus Placebo in Early PD Patients

This study has been completed.

Sponsor:

Information provided by:

Boehringer Ingelheim Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00479401

First received: May 25, 2007

Last updated: May 18, 2012

Last verified: May 2012

History of Changes

Results First Received: November 20, 2009

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Primary Purpose: Treatment
Condition:	Parkinson Disease
Interventions:	Drug: Pramipexol Extended Release Drug: Pramipexol Immediate Release Drug: 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
Pramipexole Extended Release (PPX ER)	PPX ER tablets taken once in the morning
Pramipexole Immediate Release (PPX IR)	PPX IR tablets taken three times a day
Placebo	Placebo to PPX ER once and to PPX IR three times a day

Participant Flow: Overall Study

	Pramipexole Extended Release (PPX ER)	Pramipexole Immediate Release (PPX IR)	Placebo
STARTED	223	213	103
COMPLETED	174	176	91
NOT COMPLETED	49	37	12
Adverse Event	24	20	4
Lack of Efficacy	2	2	4
Protocol Violation	2	1	1
Lost to Follow-up	1	1	1
Withdrawal by Subject	16	10	2
Exclusion criteria, relocation	4	3	0

Baseline Characteristics

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Reporting Groups

	Description
Pramipexole Extended Release (PPX ER)	PPX ER tablets taken once in the morning
Pramipexole Immediate Release (PPX IR)	PPX IR tablets taken three times a day
Placebo	Placebo to PPX ER once and to PPX IR three times a day
Total	Total of all reporting groups

Baseline Measures

	Pramipexole Extended Release (PPX ER)	Pramipexole Immediate Release (PPX IR)	Placebo	Total
Number of Participants [units: participants]	223	213	103	539
Age [units: years] Mean ± Standard Deviation	61.3 ± 9.8	61.7 ± 9.6	62.0 ± 9.6	61.6 ± 9.7
Gender [units: participants]
Female	96	92	52	240
Male	127	121	51	299

Outcome Measures

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1. Primary:

Change From Baseline in UPDRS (Unified Parkinson's Disease Rating Scale) Parts II+III Total Score [ Time Frame: baseline and after 33 weeks treatment ]

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2. Secondary:

Percentage of Responders on the Clinical Global Impressions of Improvement (CGI-I) Scale [ Time Frame: after 18 weeks of treatment compared to baseline ]

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3. Secondary:

Percentage of Responders on the Patients Global Impressions of Improvement (PGI-I) Scale [ Time Frame: after 18 weeks of treatment compared to baseline ]

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4. Secondary:

UPDRS II+III Responder Rate (at Least 20% Improvement) [ Time Frame: after 33 weeks treatment ]

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5. Secondary:

UPDRS Part I Change From Baseline [ Time Frame: baseline and after 33 weeks treatment ]

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6. Secondary:

UPDRS Part II Total Score [ Time Frame: after 33 weeks treatment ]

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Measure Type	Secondary
Measure Title	UPDRS Part II Total Score
Measure Description	UPDRS II evaluates activities of dailiy living in a score 0-52. Decrease of the score means improvement
Time Frame	after 33 weeks treatment
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.
Full Analysis Set, all randomized patients, received at least one dose of study drug and provided any post baseline efficacy assessment

Reporting Groups

	Description
Pramipexole Extended Release (PPX ER)	PPX ER tablets taken once in the morning
Pramipexole Immediate Release (PPX IR)	PPX IR tablets taken three times a day
Placebo	Placebo to PPX ER once and to PPX IR three times a day

Measured Values

	Pramipexole Extended Release (PPX ER)	Pramipexole Immediate Release (PPX IR)	Placebo
Number of Participants Analyzed [units: participants]	213	207	103
UPDRS Part II Total Score [units: UPDRS score] Mean ( 95% Confidence Interval )	-2.2 ( -2.6 to -1.7 )	-2.4 ( -2.9 to -2.0 )	-0.9 ( -1.5 to -0.3 )

No statistical analysis provided for UPDRS Part II Total Score

7. Secondary:

UPDRS Part III Total Score [ Time Frame: after 33 weeks treatment ]

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8. Secondary:

Beck's Depression Inventory Version I A [ Time Frame: after 33 weeks treatment ]

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9. Secondary:

Likert Scale for Pain Related to PD [ Time Frame: after 33 weeks treatment ]

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10. Secondary:

Parkinson's Disease Sleep Scale [ Time Frame: after 33 weeks treatment ]

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11. Secondary:

Parkinson's Disease Quality of Life Questionnaire [ Time Frame: after 33 weeks treatment ]

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12. Secondary:

European Quality of Life Scale [ Time Frame: after 33 weeks treatment ]

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13. Secondary:

Patients Who Started to Use L-Dopa Rescue Medication [ Time Frame: from trial start on to any time before final assessment of the patient ]

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14. Secondary:

Number of Patients With Treatment Emergent Abnormal Behaviour as Indicated by the Modified Minnesota Impulsive Disorders Interview (mMIDI Questionnaire) [ Time Frame: any time during the study ]

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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 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:	NCT00479401 History of Changes
Other Study ID Numbers:	248.524, Eudract No 2007-000073-39
Study First Received:	May 25, 2007
Results First Received:	November 20, 2009
Last Updated:	May 18, 2012
Health Authority:	Argentina: A.N.M.A.T. (Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica) Austria: Federal Office for Safety in Health Care Czech Republic: SUKL (state institute for drug control) Finland: Finnish Medicines Agency Germany: Federal Institute for Drugs and Medical Devices Hungary: National Institute of Pharmacy, H-1051 Budapest India: Drug Control General of India Japan: Ministry of Health, Labor and Welfare Malaysia: Ministry of Health, Malaysia Russia: Ministry of Healthcare and Social Development of Russian Federation, Moscow Slovakia: SUKL (state institute for drug control) Taiwan: Department of Health, Executive Yuan, Taiwan Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine) United States: Food and Drug Administration

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