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

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

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
Overall Participants Analyzed  [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

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 ]

2.  Primary:

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

3.  Primary:

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

4.  Primary:

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

5.  Primary:

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

6.  Secondary:

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

7.  Secondary:

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

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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