A Placebo- and Active-Controlled Study of Preladenant in Early Parkinson's Disease (PD) (P05664) (PARADYSE)

This study has been terminated.

(Termininated for business reasons)

Sponsor:

Information provided by (Responsible Party):

Merck Sharp & Dohme Corp.

ClinicalTrials.gov Identifier:

NCT01155479

First received: June 30, 2010

Last updated: June 15, 2016

Last verified: June 2016

History of Changes

Results First Received: June 15, 2016

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Parkinson Disease
Interventions:	Drug: Preladenant 2 mg tablet Drug: Preladenant 5 mg tablet Drug: Preladenant 10 mg tablet Drug: Rasagiline 1 mg capsule Drug: Placebo for Rasagiline 1 mg capsule Drug: Placebo for Preladenant

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
Participants with a diagnosis of idiopathic PD for less than 5 years were selected to participate in this study.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
In Part 1, participants were randomized to one of five treatment groups and treated for 26 weeks. In Part 2, which was conducted for an additional 26 weeks, participants continued taking the same study treatment from Part 1, except for placebo participants who were re-assigned to receive preladenant 5 mg twice daily.

Reporting Groups

	Description
Preladenant 2 mg	Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
Preladenant 5 mg	Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
Preladenant 10 mg	Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
Placebo	Participants received placebo for preladenant and placebo for rasagiline in the AM followed by placebo for preladenant in the PM for 26 weeks (Part 1); preladenant 5 mg was taken twice daily for 26 weeks (Part 2).
Rasagiline	Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).

Participant Flow for 2 periods

Period 1: Part I

	Preladenant 2 mg	Preladenant 5 mg	Preladenant 10 mg	Placebo	Rasagiline
STARTED	204	204	206	204	204
Treated	200	202	204	198	203
COMPLETED	166	177	167	177	181
NOT COMPLETED	38	27	39	27	23
Adverse Event	13	8	18	7	6
Administrative	2	2	2	0	0
Did Not Meet Protocol Eligibility	3	1	2	1	3
Withdrawal by Subject	11	13	8	8	9
Lost to Follow-up	0	0	1	1	0
Treatment Failure	3	0	3	1	2
Did Not Receive Treatment	4	2	2	6	1
Non-Compliance with Protocol	2	1	3	3	2

Period 2: Part II

	Preladenant 2 mg	Preladenant 5 mg	Preladenant 10 mg	Placebo	Rasagiline
STARTED	166	177	167	177	181
COMPLETED	107	116	109	127	126
NOT COMPLETED	59	61	58	50	55
Adverse Event	7	6	8	3	4
Administrative	43	49	36	38	46
Withdrawal by Subject	8	4	12	7	3
Lost to Follow-up	1	0	0	0	1
Treatment Failure	0	1	2	0	1
Non-Compliance with Protocol	0	1	0	2	0

Baseline Characteristics

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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.
All Participants as Randomized

Reporting Groups

	Description
Preladenant 2 mg	Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
Preladenant 5 mg	Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
Preladenant 10 mg	Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
Placebo	Participants received placebo for preladenant and placebo for rasagiline in the AM followed by placebo for preladenant in the PM for 26 weeks (Part 1); preladenant 5 mg was taken twice daily for 26 weeks (Part 2).
Rasagiline	Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
Total	Total of all reporting groups

Baseline Measures

	Preladenant 2 mg	Preladenant 5 mg	Preladenant 10 mg	Placebo	Rasagiline	Total
Number of Participants [units: participants]	204	204	206	204	204	1022
Age [units: Years] Mean (Standard Deviation)	63.0 (10.5)	62.3 (10.2)	63.8 (11.1)	63.3 (10.0)	62.9 (10.2)	63.1 (10.4)
Gender [units: Participants]
Female	78	90	90	82	85	425
Male	126	114	116	122	119	597

Outcome Measures

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1. Primary:

Change From Baseline in the Sum of Unified Parkinson’s Disease Rating Scale Parts 2 and 3 Scores (UPDRS2+3) [ Time Frame: Baseline and Week 26 ]

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2. Primary:

Number of Participants With Adverse Events (AEs) in Part 1 [ Time Frame: Day 1 to Week 26 ]

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3. Primary:

Number of Participants Who Discontinued Study Due to an AE in Part 1 [ Time Frame: Day 1 to Week 26 ]

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4. Primary:

Number of Participants With Adverse Events (AEs) in Part 2 [ Time Frame: Week 27 to Week 52 ]

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5. Primary:

Number of Participants Who Discontinued Study Due to an AE in Part 2 [ Time Frame: Week 27 to Week 52 ]

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6. Secondary:

Percentage of Responders (Participants With a ≥20% Improvement in UPDRS2+3) [ Time Frame: Baseline and Week 26 ]

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7. Secondary:

Change From Baseline in the UPDRS Part 2 Score (Activities of Daily Living [ADL]) [ Time Frame: Baseline and Week 26 ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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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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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: The Investigator agrees not to publish or publicly present any interim results of the trial without the prior written consent of the sponsor. The Investigator further agrees to provide the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the trial. The sponsor shall have the right to review and comment.

Results Point of Contact:

Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com

Responsible Party:	Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:	NCT01155479 History of Changes
Other Study ID Numbers:	P05664 2009-013552-72 ( EudraCT Number ) MK-3814-024 ( Other Identifier: Merck Study Number )
Study First Received:	June 30, 2010
Results First Received:	June 15, 2016
Last Updated:	June 15, 2016
Health Authority:	United States: Food and Drug Administration

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