Pivotal Study in Advanced Parkinsons Disease Patients

This study has been completed.

Sponsor:

Information provided by:

Boehringer Ingelheim Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00466167

First received: April 25, 2007

Last updated: May 18, 2012

Last verified: May 2012

History of Changes

Results First Received: November 17, 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 ER

Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning

Pramipexole IR

Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"

Placebo

Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day

Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning

Participant Flow: Overall Study

	Pramipexole ER	Pramipexole IR	Placebo
STARTED	164	175	178
COMPLETED	145	163	157
NOT COMPLETED	19	12	21
Adverse Event	8	8	7
Lack of Efficacy	2	0	3
Protocol Violation	1	1	2
Lost to Follow-up	3	2	2
Withdrawal by Subject	4	1	6
patient did not meet inclusion criteria	1	0	1

Baseline Characteristics

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Reporting Groups

	Description
Pramipexole ER	Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
Pramipexole IR	Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
Placebo	Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
Total	Total of all reporting groups

Baseline Measures

	Pramipexole ER	Pramipexole IR	Placebo	Total
Number of Participants [units: participants]	164	175	178	517
Age [units: years] Mean ± Standard Deviation	61.6 ± 9.7	62.0 ± 10.3	60.9 ± 9.7	61.5 ± 9.9
Gender [units: participants]
Female	72	77	84	233
Male	92	98	94	284

Outcome Measures

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1. Primary:

Change From Baseline in UPDRS (Unified Parkinson's Disease Rating Scale) Parts II+III Score at Week 18 [ Time Frame: baseline and week 18 ]

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2. Secondary:

Change From Baseline in Percentage Off-time at Week 18 [ Time Frame: baseline and week 18 ]

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3. Secondary:

Change From Baseline in Percentage On-time Without Dyskinesia at Week 18 [ Time Frame: baseline and week 18 ]

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4. Secondary:

Change From Baseline in Percentage On-time With Non-troublesome Dyskinesia at Week 18 [ Time Frame: baseline and week 18 ]

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5. Secondary:

Change From Baseline in Percentage On-time With Troublesome Dyskinesia at Week 18 [ Time Frame: baseline and week 18 ]

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6. Secondary:

Clinical Global Impression - Global Improvement (CGI-I) Responder [ Time Frame: after 18 weeks of treatment ]

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7. Secondary:

Response in Patient Global Impression (PGI-I) [ Time Frame: after 18 weeks of treatment ]

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8. Secondary:

Change From Baseline in UPDRS I Score After 18 Weeks [ Time Frame: baseline and 18 weeks ]

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9. Secondary:

Change From Baseline in UPDRS II Score After 18 Weeks, Average at on and Off-period [ Time Frame: baseline and 18 weeks ]

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10. Secondary:

Change From Baseline in UPDRS III Score After 18 Weeks [ Time Frame: baseline and 18 weeks ]

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11. Secondary:

Change From Baseline in UPDRS IV Score After 18 Weeks [ Time Frame: baseline and 18 weeks ]

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12. Secondary:

Change From Baseline in Beck's Depression Inventory (BDI) After 18 Weeks [ Time Frame: baseline and 18 weeks ]

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13. Secondary:

Change From Baselne in Parkinson's Disease Sleep Scale (PDSS) After 18 Weeks [ Time Frame: baseline and 18 weeks ]

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14. Secondary:

Change From Baseline in Parkinson's Disease Quality of Life Questionnaire 39 After 18 Weeks [ Time Frame: baseline and 18 weeks ]

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15. Secondary:

Change From Baseline in European Quality of Life (EuroQol) Scale After 18 Weeks [ Time Frame: baseline and 18 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
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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:	NCT00466167 History of Changes
Other Study ID Numbers:	248.525
Study First Received:	April 25, 2007
Results First Received:	November 17, 2009
Last Updated:	May 18, 2012
Health Authority:	Austria: Federal Office for Safety in Health Care Czech Republic: SUKL (state institute for drug control) Great Britain: MHRA Hungary: National Institute of Pharmacy, H-1051 Budapest India: Drug Control General of India Italy: Comitato di Bioetica Az. Policlinico di Catania - CATANIA Korea, Republic of: Korea Food and Drug Administration (KFDA) Philippines: Department of Health, Republic of the Philippines Poland: Registration Medicinal Product Medical Device Biocidal Product Russia: Ministry of Healthcare and Social Development of Russian Federation, Moscow Slovakia: SUKL (state institute for drug control), SK-825 08 Bratislava 26 Spain: Spanish Agency for Medicines and Health Products Sweden: Regional Ethics Committee of Stockholm, PO Box 289, SE-17177 Stockholm, Sweden. Medical Products Agency, PO Box 26, SE-751 03 Uppsala, Sweden Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine)

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