Efficacy, Safety and Tolerability of PF-06649751 in Parkinson's Disease Patients With Motor Fluctuations

• ClinicalTrials.gov Identifier: NCT02687542
• Recruitment Status: Terminated
• First Posted: February 22, 2016
• Results First Posted: December 24, 2018
• Last Update Posted: November 23, 2020
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

• Study Type: Interventional
• Study Design: Allocation: Randomized; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
• Condition: Parkinson Disease
• Interventions: Drug: Placebo; Drug: PF-06649751 low dose (1 mg QD); Drug: PF-06649751 middle dose 1 (3 mg QD); Drug: PF-06649751 middle dose 2 (7 mg QD); Drug: PF-06649751 high dose (15 mg QD)
• Enrollment: 108

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Placebo	PF-06649751 1 mg QD	PF-06649751 3 mg QD	PF-06649751 7 mg QD	PF-06649751 15 mg QD
Arm/Group Description	The participants swallowed 3 tablets once daily (QD) at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks. A follow-up visit was at Week 17, 2 weeks after discontinuation of Placebo. A follow-up phone visit was scheduled at Week 19 for participant's safety.	The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety.	The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety.	The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety.	The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety.
Period Title: Overall Study
Started	23	13	15	13	44
Completed	15	1	1	3	24
Not Completed	8	12	14	10	20
Reason Not Completed
Medication error without associated AEs	0	0	0	0	1
Lost to Follow-up	0	0	0	0	1
Protocol Violation	0	1	0	0	0
Other	5	9	10	6	5
Adverse Event	3	1	3	2	9
Withdrawal by Subject	0	1	1	2	4

Baseline Characteristics

Arm/Group Title		Placebo	PF-06649751 1 mg QD	PF-06649751 3 mg QD	PF-06649751 7 mg QD	PF-06649751 15 mg QD	Total
Arm/Group Description		The participants swallowed 3 tablets once daily (QD) at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks. A follow-up visit was at Week 17, 2 weeks after discontinuation of Placebo. A follow-up phone visit was scheduled at Week 19 for participant's safety.	The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety.	The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety.	The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety.	The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety.	Total of all reporting groups
Overall Number of Baseline Participants		23	13	15	13	44	108
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	23 participants	13 participants	15 participants	13 participants	44 participants	108 participants
		66.04 (8.79)	66.92 (8.79)	63.80 (7.76)	67.77 (9.36)	63.41 (8.47)	64.97 (8.60)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	23 participants	13 participants	15 participants	13 participants	44 participants	108 participants
	Female	6 26.1%	6 46.2%	6 40.0%	4 30.8%	18 40.9%	40 37.0%
	Male	17 73.9%	7 53.8%	9 60.0%	9 69.2%	26 59.1%	68 63.0%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	23 participants	13 participants	15 participants	13 participants	44 participants	108 participants
	Hispanic or Latino	3 13.0%	3 23.1%	1 6.7%	1 7.7%	3 6.8%	11 10.2%
	Not Hispanic or Latino	20 87.0%	10 76.9%	13 86.7%	12 92.3%	40 90.9%	95 88.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	1 6.7%	0 0.0%	1 2.3%	2 1.9%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	23 participants	13 participants	15 participants	13 participants	44 participants	108 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%	1 7.7%	0 0.0%	1 0.9%
	Asian	1 4.3%	0 0.0%	2 13.3%	1 7.7%	6 13.6%	10 9.3%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Black or African American	2 8.7%	1 7.7%	0 0.0%	2 15.4%	1 2.3%	6 5.6%
	White	20 87.0%	12 92.3%	12 80.0%	9 69.2%	36 81.8%	89 82.4%
	More than one race	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	1 6.7%	0 0.0%	1 2.3%	2 1.9%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Daily OFF Time at Week 10
Description	A paper Hauser diary was utilized to record motor state for half-hour intervals. Participants completed the diary by answering whether they had been OFF for 3 consecutive days in the week prior to each visit (except Day 28 visit), including 3 consecutive days during the week prior to Day 0 (Randomization). The daily OFF time was calculated as the average of the 3 consecutive daily OFF hours from the Hauser diary at each visit.
Time Frame	Week 10; Baseline was defined as the average daily OFF time (using 3 Hauser patient diary days) prior to Day -1 (study derived day and equalled to nominal visit day 0).

Outcome Measure Data

Analysis Population Description

Full Analysis Set consisted of all participants randomized who completed at least 1 post-dose efficacy measurement (Hauser home diary).

Arm/Group Title	Placebo	PF-06649751 1 mg QD	PF-06649751 3 mg QD	PF-06649751 7 mg QD	PF-06649751 15 mg QD
Arm/Group Description:	The participants swallowed 3 tablets once daily (QD) at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks. A follow-up visit was at Week 17, 2 weeks after discontinuation of Placebo. A follow-up phone visit was scheduled at Week 19 for participant's safety.	The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety.	The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety.	The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety.	The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety.
Overall Number of Participants Analyzed	21	7	9	9	41
Least Squares Mean (Standard Error); Unit of Measure: Hours
	-0.969 (0.4092)	-1.173 (0.3482)	-1.316 (0.3289)	-1.480 (0.3460)	-1.663 (0.4297)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-06649751 15 mg QD
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	Bayesian Dose Response Analysis
Statistical Test of Hypothesis	P-Value	0.5776
	Comments	Bayesian Predictive Test for Emax (the additive increase over Placebo in the response of PF-06649751 at a theoretically infinite dose) Monotonicity
	Method	Bayesian Dose Response Analysis
	Comments	Estimate and 90% credible interval of Bayesian dose response difference from placebo
Method of Estimation	Estimation Parameter	Bayesian Dose Reponse Estimate
	Estimated Value	-0.693
	Confidence Interval	(2-Sided) 90%; -1.713 to 0.304
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.6162
	Estimation Comments	[Not Specified]

2. Secondary Outcome

Title	Change From Baseline in Daily OFF Time
Description	A paper Hauser diary was utilized to record motor state for half hour intervals. Participants completed the diary by answering whether they had been OFF for 3 consecutive days in the week prior to each visit (except Day 28 visit), including 3 consecutive days during the week prior to Day 0 (Randomization). The daily OFF time was calculated as the average of the 3 consecutive daily OFF hours from the Hauser diary at each visit. Results at Week 15 should be interpreted with caution given almost half the participants were not available for this analysis at Week 15 as compared to Week 10 and the complicated nature of protocol changes that impacted the study design after Week 10.
Time Frame	Weeks 3, 5, 10 and 15; Baseline was defined as the average daily OFF time (using 3 Hauser patient diary days) prior to Day -1 (study derived day and equalled to nominal visit day 0).

Outcome Measure Data

Analysis Population Description

Full Analysis Set consisted of all participants randomized who completed at least 1 post-dose efficacy measurement (Hauser home diary).

Arm/Group Title		Placebo	PF-06649751 1 mg QD	PF-06649751 3 mg QD	PF-06649751 7 mg QD	PF-06649751 15 mg QD
Arm/Group Description:		The participants swallowed 3 tablets once daily (QD) at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks. A follow-up visit was at Week 17, 2 weeks after discontinuation of Placebo. A follow-up phone visit was scheduled at Week 19 for participant's safety.	The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety.	The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety.	The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety.	The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety.
Overall Number of Participants Analyzed		21	7	9	9	41
Least Squares Mean (Standard Error); Unit of Measure: Hours
Change at Week 3	Number Analyzed	18 participants	6 participants	8 participants	6 participants	37 participants
		-0.67 (0.620)	-0.82 (1.237)	-0.55 (1.091)	-1.82 (1.182)	-1.01 (0.464)
Change at Week 5	Number Analyzed	17 participants	5 participants	6 participants	7 participants	32 participants
		-0.63 (0.490)	-2.04 (1.054)	-2.23 (0.964)	-1.41 (0.937)	-1.24 (0.392)
Change at Week 10	Number Analyzed	16 participants	3 participants	2 participants	5 participants	25 participants
		-0.99 (0.628)	-0.60 (1.423)	-1.00 (1.508)	-2.07 (1.187)	-1.63 (0.502)
Change at Week 15	Number Analyzed	7 participants	1 participants	1 participants	3 participants	14 participants
		1.05 (1.063)	-0.67 (2.960)	-2.75 (2.936)	-1.09 (1.687)	-2.47 (0.793)

3. Secondary Outcome

Title	Change From Baseline in Daily ON Time With Troublesome Dyskinesia
Description	A paper Hauser diary was utilized to record motor state for half hour intervals. The participants answered the Hauser diary on whether they had been ON with troublesome dyskinesia. A diary day started with the interval 24:00-0:30 through 23:30-24:00 on each chronological day for 3 consecutive days. On the days recording the home diary, participants made an entry every 30 minutes during their normal waking time and upon awakening from time asleep. The daily ON hours was calculated as the average of the 3 consecutive daily ON hours from the Hauser diary at each visit. Results at Week 15 should be interpreted with caution given almost half the participants were not available for this analysis at Week 15 as compared to Week 10 and the complicated nature of protocol changes that impacted the study design after Week 10.
Time Frame	Weeks 3, 5, 10 and 15; Baseline was defined as the average daily ON time with Troublesome Dyskinesia (using 3 Hauser patient diary Days) prior to Day -1 (study derived day and equalled to nominal visit Day 0).

Outcome Measure Data

Analysis Population Description

Full Analysis Set consisted of all participants randomized who completed at least 1 post-dose efficacy measurement (Hauser home diary).

Arm/Group Title		Placebo	PF-06649751 1 mg QD	PF-06649751 3 mg QD	PF-06649751 7 mg QD	PF-06649751 15 mg QD
Arm/Group Description:		The participants swallowed 3 tablets once daily (QD) at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks. A follow-up visit was at Week 17, 2 weeks after discontinuation of Placebo. A follow-up phone visit was scheduled at Week 19 for participant's safety.	The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety.	The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety.	The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety.	The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety.
Overall Number of Participants Analyzed		21	7	9	9	41
Least Squares Mean (Standard Error); Unit of Measure: Hours
Change at Week 3	Number Analyzed	18 participants	6 participants	8 participants	6 participants	37 participants
		0.17 (0.236)	0.07 (0.467)	0.19 (0.417)	0.01 (0.464)	0.23 (0.179)
Change at Week 5	Number Analyzed	17 participants	5 participants	6 participants	7 participants	32 participants
		0.23 (0.198)	-0.21 (0.415)	-0.02 (0.388)	0.45 (0.363)	0.03 (0.162)
Change at Week 10	Number Analyzed	16 participants	3 participants	2 participants	5 participants	25 participants
		0.13 (0.191)	0.24 (0.464)	0.32 (0.529)	-0.39 (0.389)	0.13 (0.167)
Change at Week 15	Number Analyzed	7 participants	1 participants	1 participants	3 participants	14 participants
		0.01 (0.642)	-0.43 (1.349)	-0.29 (1.263)	0.54 (1.071)	-0.21 (0.463)

4. Secondary Outcome

Title	Change From Baseline in Daily ON Time Without Troublesome Dyskinesia
Description	A paper Hauser diary was utilized to record motor state for half hour intervals. The participants answered the Hauser diary on whether they had been ON without troublesome dyskinesia. A diary day started with the interval 24:00-0:30 through 23:30-24:00 on each chronological day for 3 consecutive days. On the days recording the home diary, participants made an entry every 30 minutes during their normal waking time and upon awakening from time asleep. The daily ON hours was calculated as the average of the 3 consecutive daily ON hours from the Hauser diary at each visit. Results at Week 15 should be interpreted with caution given almost half the participants were not available for this analysis at Week 15 as compared to Week 10 and the complicated nature of protocol changes that impacted the study design after Week 10.
Time Frame	Weeks 3, 5, 10 and 15; Baseline was defined as the average daily ON time without Troublesome Dyskinesia (using 3 Hauser patient diary days) prior to Day -1 (study derived day and equalled to nominal visit Day 0)

Outcome Measure Data

Analysis Population Description

Full Analysis Set consisted of all participants randomized who completed at least 1 post-dose efficacy measurement (Hauser home diary).

Arm/Group Title		Placebo	PF-06649751 1 mg QD	PF-06649751 3 mg QD	PF-06649751 7 mg QD	PF-06649751 15 mg QD
Arm/Group Description:		The participants swallowed 3 tablets once daily (QD) at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks. A follow-up visit was at Week 17, 2 weeks after discontinuation of Placebo. A follow-up phone visit was scheduled at Week 19 for participant's safety.	The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety.	The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety.	The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety.	The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety.
Overall Number of Participants Analyzed		21	7	9	9	41
Least Squares Mean (Standard Error); Unit of Measure: Hours
Change at Week 3	Number Analyzed	18 participants	6 participants	8 participants	6 participants	37 participants
		0.61 (0.577)	1.74 (1.173)	-0.49 (1.047)	1.93 (1.128)	0.77 (0.443)
Change at Week 5	Number Analyzed	17 participants	5 participants	6 participants	7 participants	32 participants
		0.02 (0.548)	2.39 (1.150)	1.31 (1.058)	1.12 (1.029)	1.31 (0.436)
Change at Week 10	Number Analyzed	16 participants	3 participants	2 participants	5 participants	25 participants
		0.61 (0.618)	0.92 (1.413)	0.45 (1.598)	2.64 (1.194)	1.65 (0.508)
Change at Week 15	Number Analyzed	7 participants	1 participants	1 participants	3 participants	14 participants
		-0.81 (1.099)	0.37 (2.999)	-4.48 (3.192)	0.94 (1.781)	1.50 (0.825)

5. Secondary Outcome

Title	Change From Baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III
Description	MDS-UPDRS Part III assessed the motor signs of Parkinson's disease and was administered by the investigator. It was comprised of 33 sub-scores based on 18 items, several with right, left or other body distribution scores. Each question was anchored with 5 responses that were linked to commonly accepted clinical terms: 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. If more than 7 of the Part III items were missing, the score for that time point was missing, otherwise MDS-UPDRS Part III score was imputed as sum of the non-missing items*(total number of items)/ (number of items non-missing). The MDS-UPDRS Part III total score range is 0-132. Higher score indicated more severe motor signs of Parkinson's disease. Results at Week 15 should be interpreted with caution given almost half the participants were not available for this analysis at Week 15 as compared to Week 10 and the complicated nature of protocol changes that impacted the study design after Week 10.
Time Frame	Weeks 1, 2, 3, 4, 5, 10 and 15; Baseline was defined as the Day -1 (study derived day and equalled to nominal visit Day 0) measurement

Outcome Measure Data

Analysis Population Description

Full Analysis Set consisted of all participants randomized who completed at least 1 post-dose efficacy measurement (Hauser home diary).

Arm/Group Title		Placebo	PF-06649751 1 mg QD	PF-06649751 3 mg QD	PF-06649751 7 mg QD	PF-06649751 15 mg QD
Arm/Group Description:		The participants swallowed 3 tablets once daily (QD) at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks. A follow-up visit was at Week 17, 2 weeks after discontinuation of Placebo. A follow-up phone visit was scheduled at Week 19 for participant's safety.	The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety.	The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety.	The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety.	The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety.
Overall Number of Participants Analyzed		21	7	9	9	41
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
Change at Week 1	Number Analyzed	21 participants	7 participants	9 participants	9 participants	41 participants
		-3.90 (2.054)	-4.44 (3.965)	-4.61 (3.593)	-1.90 (3.594)	-3.22 (1.524)
Change at Week 2	Number Analyzed	11 participants	1 participants	0 participants	1 participants	20 participants
		-0.95 (2.078)	-15.78 (6.252)		0.56 (6.129)	-3.70 (1.584)
Change at Week 3	Number Analyzed	10 participants	1 participants	0 participants	0 participants	20 participants
		-3.80 (2.848)	-12.39 (8.240)			-3.06 (2.069)
Change at Week 4	Number Analyzed	18 participants	7 participants	9 participants	9 participants	37 participants
		-6.28 (2.182)	-0.84 (3.940)	-2.48 (3.572)	-2.91 (3.575)	-6.05 (1.574)
Change at Week 5	Number Analyzed	18 participants	6 participants	6 participants	8 participants	34 participants
		-5.12 (2.386)	-6.14 (4.414)	3.10 (4.347)	-1.22 (3.935)	-4.86 (1.765)
Change at Week 10	Number Analyzed	17 participants	5 participants	2 participants	6 participants	30 participants
		-5.09 (1.967)	-2.21 (3.902)	5.77 (5.365)	-2.36 (3.607)	-9.32 (1.526)
Change at Week 15	Number Analyzed	8 participants	1 participants	1 participants	3 participants	15 participants
		-0.18 (3.170)	7.72 (8.660)	2.09 (9.495)	-5.44 (5.364)	-1.84 (2.519)

6. Secondary Outcome

Title	Change From Baseline in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I, II, IV, and Total Score
Description	Each question of Part I,II or IV with 5 responses was linked to the same clinical terms as Part III.The score was missing if more than 7 items were missing for a time point; otherwise Part I,II or IV score was imputed as sum of non-missing items*(total number of items)/(number of items non-missing).•PartI (Non-Motor Aspects of Experiences of Daily Living) assessed non-motor experiences of daily living using 13questions(Range:0-52).•PartII(Motor Aspects of Experiences of Daily Living) assessed motor experiences of daily living using 13questions(Range:0-52).•PartIV(Motor Complications) assessed motor complications,dyskinesias, and motor fluctuations using historical and objective information with 6questions(Range:0-24).•MDS-UPDRS Total Score:the sum of Parts I,II,III,and IV(Range:0-260).Higher score indicated more severe motor signs of Parkinson's disease.Week15's results were interpreted cautiously given almost half participants were not available for the analysis as compared to Week10
Time Frame	Weeks 5, 10 and 15; Baseline was defined as the Day -1 (study derived day and equalled to nominal visit Day 0) measurement

Outcome Measure Data

Analysis Population Description

Full Analysis Set included all participants randomized who completed at least 1 postdose efficacy measurement(Hauser home diary).

Arm/Group Title		Placebo	PF-06649751 1 mg QD	PF-06649751 3 mg QD	PF-06649751 7 mg QD	PF-06649751 15 mg QD
Arm/Group Description:		The participants swallowed 3 tablets once daily (QD) at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks. A follow-up visit was at Week 17, 2 weeks after discontinuation of Placebo. A follow-up phone visit was scheduled at Week 19 for participant's safety.	The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety.	The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety.	The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety.	The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety.
Overall Number of Participants Analyzed		21	7	9	9	41
Mean (Standard Deviation); Unit of Measure: units on a scale
Change at Week 5 (Part I Score)	Number Analyzed	16 participants	6 participants	6 participants	8 participants	34 participants
		-0.75 (5.508)	-0.83 (1.941)	0.67 (4.885)	2.00 (4.408)	1.12 (4.879)
Change at Week 10 (Part I Score)	Number Analyzed	16 participants	5 participants	2 participants	6 participants	30 participants
		-0.69 (4.557)	-0.80 (2.168)	-1.00 (2.828)	0.00 (2.449)	0.17 (4.086)
Change at Week 15 (Part I Score)	Number Analyzed	7 participants	1 participants	1 participants	3 participants	15 participants
		-2.86 (6.176)	2.00 [1] (NA)	6.00 [1] (NA)	-1.00 (1.732)	1.00 (5.745)
Change at Week 5 (Part II Score)	Number Analyzed	18 participants	6 participants	6 participants	8 participants	34 participants
		0.06 (5.836)	-1.83 (2.639)	3.00 (4.940)	-0.03 (3.083)	-0.24 (4.068)
Change at Week 10 (Part II Score)	Number Analyzed	17 participants	5 participants	2 participants	6 participants	30 participants
		-0.35 (5.267)	-1.00 (1.225)	5.00 (1.414)	0.13 (2.428)	-0.43 (4.240)
Change at Week 15 (Part II Score)	Number Analyzed	8 participants	1 participants	1 participants	3 participants	15 participants
		-1.38 (4.779)	2.00 [1] (NA)	8.00 [1] (NA)	-2.42 (5.270)	1.47 (5.986)
Change at Week 5 (Part IV Score)	Number Analyzed	18 participants	6 participants	6 participants	8 participants	34 participants
		-1.50 (2.895)	-0.83 (2.401)	-0.50 (4.848)	0.25 (2.053)	-0.65 (2.806)
Change at Week 10 (Part IV Score)	Number Analyzed	17 participants	5 participants	2 participants	6 participants	30 participants
		-2.00 (2.318)	0.80 (1.304)	-3.00 (5.657)	0.00 (1.789)	-1.13 (3.530)
Change at Week 15 (Part IV Score)	Number Analyzed	8 participants	1 participants	1 participants	3 participants	15 participants
		-2.75 (2.493)	-2.00 [1] (NA)	-7.00 [1] (NA)	-1.33 (2.082)	-1.27 (2.404)
Change at Week 5 (Total Score)	Number Analyzed	16 participants	6 participants	6 participants	8 participants	34 participants
		-8.88 (12.832)	-10.00 (7.616)	5.33 (16.860)	2.34 (12.010)	-4.21 (18.216)
Change at Week 10 (Total Score)	Number Analyzed	16 participants	5 participants	2 participants	6 participants	30 participants
		-8.75 (10.951)	-3.60 (8.649)	6.50 (7.778)	0.13 (10.569)	-11.40 (18.448)
Change at Week 15 (Total Score)	Number Analyzed	7 participants	1 participants	1 participants	3 participants	15 participants
		-7.86 (12.456)	0.00 [1] (NA)	13.00 [1] (NA)	-9.08 (13.135)	0.73 (17.260)

[1]

Only 1 participant evaluable in this treatment group.

7. Secondary Outcome

Title	Number of Participants With Laboratory Abnormalities Without Regard to Baseline Abnormality
Description	The safety laboratory tests including Hematology, Clinical Chemistry and Urinalysis were performed. Determination if there were any laboratory data abnormalities of potential clinical concern was based on Pfizer Data Standards. Incidence of laboratory test abnormalities (without regard to baseline abnormality) was summarized within each treatment group.
Time Frame	Baseline (Day 0) to Week 17

Outcome Measure Data

Analysis Population Description

Safety Analysis Set included all participants who received at least 1 dose of PF-06649751 or placebo.

Arm/Group Title	Placebo	PF-06649751 1 mg QD	PF-06649751 3 mg QD	PF-06649751 7 mg QD	PF-06649751 15 mg QD
Arm/Group Description:	The participants swallowed 3 tablets once daily (QD) at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks. A follow-up visit was at Week 17, 2 weeks after discontinuation of Placebo. A follow-up phone visit was scheduled at Week 19 for participant's safety.	The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety.	The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety.	The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety.	The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety.
Overall Number of Participants Analyzed	23	12	15	13	44
Measure Type: Count of Participants; Unit of Measure: Participants
	19 82.6%	4 33.3%	9 60.0%	7 53.8%	25 56.8%

8. Secondary Outcome

Title	Number of Participants With Vital Sign Results Meeting the Criteria for Categorical Summarization
Description	Vital Signs including blood pressure and pulse rate were measured. Vital signs were collected first while the participant was in the supine position and then in the standing position.
Time Frame	Baseline (Day 0) to Week 17

Outcome Measure Data

Analysis Population Description

Safety Analysis Set included all participants who received at least 1 dose of PF-06649751 or placebo and had evaluable data at specified categories.

Arm/Group Title		Placebo	PF-06649751 1 mg QD	PF-06649751 3 mg QD	PF-06649751 7 mg QD	PF-06649751 15 mg QD
Arm/Group Description:		The participants swallowed 3 tablets once daily (QD) at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks. A follow-up visit was at Week 17, 2 weeks after discontinuation of Placebo. A follow-up phone visit was scheduled at Week 19 for participant's safety.	The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety.	The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety.	The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety.	The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety.
Overall Number of Participants Analyzed		23	13	15	13	44
Measure Type: Count of Participants; Unit of Measure: Participants
<90 mmHg (Supine Systolic Blood Pressure [SBP])	Number Analyzed	23 participants	13 participants	15 participants	13 participants	44 participants
		1 4.3%	1 7.7%	2 13.3%	0 0.0%	3 6.8%
Max-Increase from Baseline >= 30 mmHg (Supine SBP)	Number Analyzed	23 participants	12 participants	15 participants	13 participants	44 participants
		4 17.4%	1 8.3%	2 13.3%	1 7.7%	3 6.8%
Max-Decrease from Baseline >= 30 mmHg (Supine SBP)	Number Analyzed	23 participants	12 participants	15 participants	13 participants	44 participants
		4 17.4%	1 8.3%	2 13.3%	2 15.4%	11 25.0%
<90 mmHg (Standing SBP)	Number Analyzed	23 participants	13 participants	15 participants	13 participants	44 participants
		4 17.4%	1 7.7%	3 20.0%	2 15.4%	7 15.9%
Max-Increase from Baseline >=30mmHg (Standing SBP)	Number Analyzed	23 participants	12 participants	15 participants	13 participants	44 participants
		4 17.4%	0 0.0%	3 20.0%	1 7.7%	3 6.8%
Max-Decrease from Baseline >=30mmHg (Standing SBP)	Number Analyzed	23 participants	12 participants	15 participants	13 participants	44 participants
		3 13.0%	0 0.0%	3 20.0%	2 15.4%	12 27.3%
<50 mmHg (Supine Diastolic Blood Pressure [DBP])	Number Analyzed	23 participants	13 participants	15 participants	13 participants	44 participants
		0 0.0%	0 0.0%	0 0.0%	1 7.7%	1 2.3%
Max-Increase from Baseline >=20 mmHg (Supine DBP)	Number Analyzed	23 participants	12 participants	15 participants	13 participants	44 participants
		1 4.3%	0 0.0%	0 0.0%	1 7.7%	3 6.8%
Max-Decrease from Baseline >=20 mmHg (Supine DBP)	Number Analyzed	23 participants	12 participants	15 participants	13 participants	44 participants
		1 4.3%	0 0.0%	2 13.3%	1 7.7%	13 29.5%
<50 mmHg (Standing DBP)	Number Analyzed	23 participants	13 participants	15 participants	13 participants	44 participants
		2 8.7%	0 0.0%	1 6.7%	2 15.4%	1 2.3%
Max-Increase from Baseline >=20mmHg (Standing DBP)	Number Analyzed	23 participants	12 participants	15 participants	13 participants	44 participants
		3 13.0%	0 0.0%	2 13.3%	0 0.0%	1 2.3%
Max-Decrease from Baseline >=20mmHg (Standing DBP)	Number Analyzed	23 participants	12 participants	15 participants	13 participants	44 participants
		5 21.7%	2 16.7%	3 20.0%	2 15.4%	17 38.6%
<40 beats per minute (bpm) (Supine Pulse Rate)	Number Analyzed	23 participants	13 participants	15 participants	13 participants	44 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
>120 bpm (Supine Pulse Rate)	Number Analyzed	23 participants	13 participants	15 participants	13 participants	44 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
<40 bpm (Standing Pulse Rate)	Number Analyzed	23 participants	13 participants	15 participants	13 participants	44 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
>140 bpm (Standing Pulse Rate)	Number Analyzed	23 participants	13 participants	15 participants	13 participants	44 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%

9. Secondary Outcome

Title	Number of Participants With Electrocardiogram (ECG) Results Meeting the Criteria for Categorical Summarization
Description	The average of the triplicate readings of ECG data was collected at each assessment time. Number of participants with ECG results meeting the criteria for categorical summarization for time from the beginning of the P wave until the beginning of the QRS complex (PR Interval), time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization (QRS Duration), time between the start of the Q wave and the end of the T wave in the heart's electrical cycle (QT Interval) and corrected QT (Fridericia correction) (QTcF Interval) were presented.
Time Frame	Baseline (Day 0) to Week 17

Outcome Measure Data

Analysis Population Description

Safety Analysis Set included all participants who received at least 1 dose of PF-06649751 or placebo and had evaluable data at specified categories.

Arm/Group Title		Placebo	PF-06649751 1 mg QD	PF-06649751 3 mg QD	PF-06649751 7 mg QD	PF-06649751 15 mg QD
Arm/Group Description:		The participants swallowed 3 tablets once daily (QD) at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks. A follow-up visit was at Week 17, 2 weeks after discontinuation of Placebo. A follow-up phone visit was scheduled at Week 19 for participant's safety.	The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety.	The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety.	The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety.	The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety.
Overall Number of Participants Analyzed		23	12	15	13	44
Measure Type: Count of Participants; Unit of Measure: Participants
>=300 msec (PR Interval)	Number Analyzed	23 participants	12 participants	15 participants	13 participants	44 participants
		1 4.3%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Max-Increase From Baseline(%)>=25/50%(PR Interval)	Number Analyzed	23 participants	12 participants	15 participants	12 participants	43 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
>=140 msec (QRS Duration)	Number Analyzed	23 participants	12 participants	15 participants	13 participants	44 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Max-Increase From Baseline(%)>=50% (QRS Duration)	Number Analyzed	23 participants	12 participants	15 participants	12 participants	43 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
>=500 msec (QT Interval)	Number Analyzed	23 participants	12 participants	15 participants	13 participants	44 participants
		1 4.3%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
450 - <480 msec (QTcF Interval)	Number Analyzed	23 participants	12 participants	15 participants	13 participants	44 participants
		2 8.7%	0 0.0%	0 0.0%	0 0.0%	1 2.3%
480 - <500 msec (QTcF Interval)	Number Analyzed	23 participants	12 participants	15 participants	13 participants	44 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
>=500 msec (QTcF Interval)	Number Analyzed	23 participants	12 participants	15 participants	13 participants	44 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Max-Increase From Baseline 30-<60 (QTcF Interval)	Number Analyzed	23 participants	12 participants	15 participants	12 participants	43 participants
		1 4.3%	0 0.0%	0 0.0%	0 0.0%	1 2.3%
Max-Increase From Baseline >=60 (QTcF Interval)	Number Analyzed	23 participants	12 participants	15 participants	12 participants	43 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%

10. Secondary Outcome

Title	Number of Participants With Suicidal Ideation Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS) at Post-baseline Visits
Description	The Columbia Suicide Severity Rating Scale (C-SSRS) was an interview based rating scale to systematically assess suicidal ideation and suicidal behavior. C-SSRS responses were mapped to the C-CASA. There were 3 key endpoints for suicidality data analysis and evaluation: Suicidal Behavior: A participant was said to have suicidal behavior if the participant had experienced completed suicide / suicide attempt / reparatory acts toward imminent suicidal behavior.; Suicidal Ideation: Any observed suicidal ideation mapped to a single C-CASA category.; Suicidal Behavior or Ideation (participants with new onset suicidality): A participant was considered to have a new onset of suicidality if the participant reported no ideation and no behavior at the baseline assessment and reported any behavior or ideation post-baseline. Data observed at screening was not considered in the definition of worsening.
Time Frame	Days 0 (Baseline), 7, 14, 21, 28, 35, 70, 77, 84, 91, 105 and 119

Outcome Measure Data

Analysis Population Description

Safety Analysis Set included all participants who received at least 1 dose of PF-06649751 or placebo and had evaluable data at specified time points.

Arm/Group Title		Placebo	PF-06649751 1 mg QD	PF-06649751 3 mg QD	PF-06649751 7 mg QD	PF-06649751 15 mg QD
Arm/Group Description:		The participants swallowed 3 tablets once daily (QD) at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks. A follow-up visit was at Week 17, 2 weeks after discontinuation of Placebo. A follow-up phone visit was scheduled at Week 19 for participant's safety.	The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety.	The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety.	The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety.	The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety.
Overall Number of Participants Analyzed		23	13	15	13	44
Measure Type: Count of Participants; Unit of Measure: Participants
Baseline	Number Analyzed	23 participants	13 participants	15 participants	13 participants	44 participants
		1 4.3%	0 0.0%	1 6.7%	0 0.0%	0 0.0%
Day 7	Number Analyzed	22 participants	11 participants	14 participants	12 participants	44 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Day 14	Number Analyzed	19 participants	7 participants	10 participants	9 participants	39 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 2.6%
Day 21	Number Analyzed	21 participants	10 participants	10 participants	8 participants	39 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	2 5.1%
Day 28	Number Analyzed	19 participants	8 participants	9 participants	11 participants	39 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Day 35	Number Analyzed	21 participants	8 participants	7 participants	10 participants	36 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 2.8%
Day 70	Number Analyzed	20 participants	6 participants	7 participants	7 participants	32 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Day 77	Number Analyzed	6 participants	0 participants	0 participants	0 participants	9 participants
		0 0.0%				0 0.0%
Day 84	Number Analyzed	7 participants	0 participants	0 participants	0 participants	8 participants
		0 0.0%				0 0.0%
Day 91	Number Analyzed	6 participants	0 participants	0 participants	0 participants	6 participants
		0 0.0%				0 0.0%
Day 105	Number Analyzed	17 participants	4 participants	3 participants	6 participants	25 participants
		0 0.0%	0 0.0%	0 0.0%	1 16.7%	0 0.0%
Day 119	Number Analyzed	15 participants	1 participants	0 participants	3 participants	25 participants
		0 0.0%	0 0.0%		0 0.0%	0 0.0%

11. Secondary Outcome

Title	Change From Baseline in Total Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease - Rating Scale (QUIP-RS)
Description	The QUIP-RS was a brief, patient reported outcome measure designed to assess the severity of symptoms of Impulsive-Compulsive Disorders (ICDs) and related behaviors reported to occur in Parkinson's disease. The QUIP-RS assessed 7 disorders (Gambling, Sex, Buying, Eating, Hobbyism-punding [performing tasks and repeating activities] and Taking medications). If more than 5 items were missing, the total QUIP-RS score was set as missing; otherwise, the total QUIP-RS score was imputed as follows: sum of the non-missing item scores * (total number of items) / (number of items non-missing). The higher score indicated a greater level of the ICD. The total QUIP-RS score for all ICDs and related disorders combined ranges from 0 to 112.
Time Frame	Baseline (Day 0) and Weeks 5, 10 and 15

Outcome Measure Data

Analysis Population Description

Safety Analysis Set included all participants who received at least 1 dose of PF-06649751 or placebo and had evaluable data at specified time points.

Arm/Group Title		Placebo	PF-06649751 1 mg QD	PF-06649751 3 mg QD	PF-06649751 7 mg QD	PF-06649751 15 mg QD
Arm/Group Description:		The participants swallowed 3 tablets once daily (QD) at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks. A follow-up visit was at Week 17, 2 weeks after discontinuation of Placebo. A follow-up phone visit was scheduled at Week 19 for participant's safety.	The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety.	The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety.	The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety.	The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety.
Overall Number of Participants Analyzed		23	13	15	13	44
Mean (Standard Deviation); Unit of Measure: units on a scale
Baseline	Number Analyzed	23 participants	13 participants	15 participants	13 participants	44 participants
		17.1 (16.98)	9.0 (12.56)	9.0 (14.39)	12.5 (11.69)	6.8 (11.40)
Change at Week 5	Number Analyzed	22 participants	11 participants	10 participants	12 participants	42 participants
		-5.6 (11.37)	2.3 (10.05)	4.7 (9.58)	-5.4 (12.28)	0.5 (11.13)
Change at Week 10	Number Analyzed	20 participants	5 participants	6 participants	6 participants	30 participants
		-3.3 (12.16)	-1.8 (7.98)	-6.5 (9.63)	-5.8 (13.50)	1.0 (10.62)
Change at Week 15	Number Analyzed	16 participants	4 participants	3 participants	4 participants	24 participants
		-11.5 (16.29)	3.0 (10.30)	-3.3 (5.77)	-17.0 (11.34)	0.4 (5.91)

12. Secondary Outcome

Title	Total Physician Withdrawal Checklist (PWC-20) on Days 105 and 119, and Change From Day 105 to Day 119
Description	The PWC-20 is a physician completed, 20 item reliable and sensitive instrument for the assessment of discontinuation symptoms. The PWC-20 was collected after the completion of study treatment and also at the first visit of follow-up. The total PWC-20 score was the sum of 20 item scores and ranged from 0 to 60. If more than 5 items were missing, the total PWC-20 score was missing; otherwise, the total PWC-20 score was imputed as follows: sum of the non-missing items * (total number of items) / (number of items non-missing). The higher score indicated more frequent/severe symptoms.
Time Frame	Days 105 and 119

Outcome Measure Data

Analysis Population Description

Safety Analysis Set included all participants who received at least 1 dose of PF-06649751 or placebo and had evaluable data at specified time points.

Arm/Group Title		Placebo	PF-06649751 1 mg QD	PF-06649751 3 mg QD	PF-06649751 7 mg QD	PF-06649751 15 mg QD
Arm/Group Description:		The participants swallowed 3 tablets once daily (QD) at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks. A follow-up visit was at Week 17, 2 weeks after discontinuation of Placebo. A follow-up phone visit was scheduled at Week 19 for participant's safety.	The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety.	The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety.	The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety.	The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety.
Overall Number of Participants Analyzed		23	13	15	13	44
Mean (Standard Deviation); Unit of Measure: units on a scale
Day 105 Early Termination (ET)	Number Analyzed	22 participants	12 participants	13 participants	13 participants	40 participants
		3.5 (3.73)	5.6 (5.68)	5.8 (6.65)	8.2 (8.78)	7.1 (6.06)
Day 119 Follow-up (FU)	Number Analyzed	15 participants	1 participants	0 participants	3 participants	25 participants
		3.3 (3.08)	6.0 [1] (NA)		7.7 (4.16)	5.8 (5.45)
Change From Day 105 ET to Day 119 FU	Number Analyzed	14 participants	1 participants	0 participants	3 participants	24 participants
		-0.6 (3.08)	-11.0 [1] (NA)		-1.7 (4.73)	-0.4 (4.79)

[1]

Only 1 participant evaluable in this treatment group.

13. Secondary Outcome

Title	Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs and Deaths
Description	An AE was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event did not need necessarily to have a causal relationship with the treatment or usage. An SAE was any untoward medical occurrence at any dose that: Resulted in death;; Was life threatening (immediate risk of death);; Required inpatient hospitalization or prolongation of existing hospitalization;; Resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions);; Resulted in congenital anomaly/birth defect.
Time Frame	Day 1 to follow-up (Week 19 visit)

Outcome Measure Data

Analysis Population Description

Safety Analysis Set included all participants who received at least 1 dose of PF-06649751 or placebo.

Arm/Group Title	Placebo	PF-06649751 1 mg QD	PF-06649751 3 mg QD	PF-06649751 7 mg QD	PF-06649751 15 mg QD
Arm/Group Description:	The participants swallowed 3 tablets once daily (QD) at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks. A follow-up visit was at Week 17, 2 weeks after discontinuation of Placebo. A follow-up phone visit was scheduled at Week 19 for participant's safety.	The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety.	The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety.	The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety.	The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety.
Overall Number of Participants Analyzed	23	13	15	13	44
Measure Type: Count of Participants; Unit of Measure: Participants
AEs	20 87.0%	7 53.8%	11 73.3%	10 76.9%	37 84.1%
SAEs	1 4.3%	1 7.7%	0 0.0%	0 0.0%	2 4.5%
Discontinuation due to AEs	3 13.0%	1 7.7%	3 20.0%	2 15.4%	9 20.5%
Death	1 4.3%	0 0.0%	0 0.0%	0 0.0%	1 2.3%

Adverse Events

Time Frame	Day 1 to follow-up (Week 19 visit)
Adverse Event Reporting Description	Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Arm/Group Title	Placebo		PF-06649751 1 mg QD		PF-06649751 3 mg QD		PF-06649751 7 mg QD		PF-06649751 15 mg QD
Arm/Group Description	The participants swallowed 3 tablets once daily (QD) at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks. A follow-up visit was at Week 17, 2 weeks after discontinuation of Placebo. A follow-up phone visit was scheduled at Week 19 for participant's safety.		The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety.		The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety.		The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety.		The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety.
All-Cause Mortality
	Placebo		PF-06649751 1 mg QD		PF-06649751 3 mg QD		PF-06649751 7 mg QD		PF-06649751 15 mg QD
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	1/23 (4.35%)		0/13 (0.00%)		0/15 (0.00%)		0/13 (0.00%)		1/44 (2.27%)
Serious Adverse Events
	Placebo		PF-06649751 1 mg QD		PF-06649751 3 mg QD		PF-06649751 7 mg QD		PF-06649751 15 mg QD
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/23 (4.35%)		1/13 (7.69%)		0/15 (0.00%)		0/13 (0.00%)		2/44 (4.55%)
Gastrointestinal disorders
Abdominal pain * 1	0/23 (0.00%)	0	0/13 (0.00%)	0	0/15 (0.00%)	0	0/13 (0.00%)	0	1/44 (2.27%)	1
Immune system disorders
Allergic oedema * 1	0/23 (0.00%)	0	0/13 (0.00%)	0	0/15 (0.00%)	0	0/13 (0.00%)	0	1/44 (2.27%)	1
Musculoskeletal and connective tissue disorders
Neck pain * 1	0/23 (0.00%)	0	0/13 (0.00%)	0	0/15 (0.00%)	0	0/13 (0.00%)	0	1/44 (2.27%)	1
Pain in extremity * 1	0/23 (0.00%)	0	0/13 (0.00%)	0	0/15 (0.00%)	0	0/13 (0.00%)	0	1/44 (2.27%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma * 1	1/23 (4.35%)	1	0/13 (0.00%)	0	0/15 (0.00%)	0	0/13 (0.00%)	0	0/44 (0.00%)	0
Renal and urinary disorders
Nephrolithiasis * 1	0/23 (0.00%)	0	1/13 (7.69%)	1	0/15 (0.00%)	0	0/13 (0.00%)	0	0/44 (0.00%)	0
Ureterolithiasis * 1	0/23 (0.00%)	0	1/13 (7.69%)	1	0/15 (0.00%)	0	0/13 (0.00%)	0	0/44 (0.00%)	0
Skin and subcutaneous tissue disorders
Dermatitis allergic * 1	0/23 (0.00%)	0	0/13 (0.00%)	0	0/15 (0.00%)	0	0/13 (0.00%)	0	1/44 (2.27%)	1
1 Term from vocabulary, MedDRA version 20.1; * Indicates events were collected by non-systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Placebo		PF-06649751 1 mg QD		PF-06649751 3 mg QD		PF-06649751 7 mg QD		PF-06649751 15 mg QD
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	15/23 (65.22%)		7/13 (53.85%)		11/15 (73.33%)		10/13 (76.92%)		31/44 (70.45%)
Cardiac disorders
Ventricular extrasystoles * 1	0/23 (0.00%)	0	0/13 (0.00%)	0	1/15 (6.67%)	1	0/13 (0.00%)	0	1/44 (2.27%)	1
Gastrointestinal disorders
Abdominal pain * 1	1/23 (4.35%)	1	1/13 (7.69%)	1	0/15 (0.00%)	0	0/13 (0.00%)	0	0/44 (0.00%)	0
Constipation * 1	1/23 (4.35%)	1	0/13 (0.00%)	0	0/15 (0.00%)	0	1/13 (7.69%)	1	1/44 (2.27%)	1
Diarrhoea * 1	0/23 (0.00%)	0	0/13 (0.00%)	0	0/15 (0.00%)	0	1/13 (7.69%)	1	1/44 (2.27%)	1
Dysphagia * 1	0/23 (0.00%)	0	0/13 (0.00%)	0	0/15 (0.00%)	0	1/13 (7.69%)	1	0/44 (0.00%)	0
Flatulence * 1	0/23 (0.00%)	0	1/13 (7.69%)	1	0/15 (0.00%)	0	0/13 (0.00%)	0	0/44 (0.00%)	0
Gastrooesophageal reflux disease * 1	0/23 (0.00%)	0	0/13 (0.00%)	0	0/15 (0.00%)	0	0/13 (0.00%)	0	3/44 (6.82%)	3
Nausea * 1	1/23 (4.35%)	1	2/13 (15.38%)	2	2/15 (13.33%)	2	1/13 (7.69%)	1	11/44 (25.00%)	14
Vomiting * 1	0/23 (0.00%)	0	0/13 (0.00%)	0	1/15 (6.67%)	1	0/13 (0.00%)	0	2/44 (4.55%)	2
General disorders
Asthenia * 1	0/23 (0.00%)	0	0/13 (0.00%)	0	1/15 (6.67%)	1	0/13 (0.00%)	0	1/44 (2.27%)	1
Fatigue * 1	3/23 (13.04%)	3	1/13 (7.69%)	1	2/15 (13.33%)	2	2/13 (15.38%)	2	1/44 (2.27%)	1
Malaise * 1	0/23 (0.00%)	0	1/13 (7.69%)	1	0/15 (0.00%)	0	0/13 (0.00%)	0	0/44 (0.00%)	0
Pyrexia * 1	0/23 (0.00%)	0	0/13 (0.00%)	0	0/15 (0.00%)	0	1/13 (7.69%)	1	0/44 (0.00%)	0
Infections and infestations
Asymptomatic bacteriuria * 1	0/23 (0.00%)	0	1/13 (7.69%)	1	0/15 (0.00%)	0	0/13 (0.00%)	0	0/44 (0.00%)	0
Chronic sinusitis * 1	0/23 (0.00%)	0	1/13 (7.69%)	1	0/15 (0.00%)	0	0/13 (0.00%)	0	0/44 (0.00%)	0
Nasopharyngitis * 1	3/23 (13.04%)	4	0/13 (0.00%)	0	0/15 (0.00%)	0	0/13 (0.00%)	0	0/44 (0.00%)	0
Tooth abscess * 1	1/23 (4.35%)	1	0/13 (0.00%)	0	0/15 (0.00%)	0	1/13 (7.69%)	1	0/44 (0.00%)	0
Injury, poisoning and procedural complications
Bone contusion * 1	0/23 (0.00%)	0	0/13 (0.00%)	0	0/15 (0.00%)	0	1/13 (7.69%)	1	0/44 (0.00%)	0
Contusion * 1	0/23 (0.00%)	0	1/13 (7.69%)	1	0/15 (0.00%)	0	2/13 (15.38%)	3	0/44 (0.00%)	0
Fall * 1	2/23 (8.70%)	2	2/13 (15.38%)	2	1/15 (6.67%)	1	2/13 (15.38%)	2	2/44 (4.55%)	3
Joint injury * 1	0/23 (0.00%)	0	0/13 (0.00%)	0	1/15 (6.67%)	1	0/13 (0.00%)	0	0/44 (0.00%)	0
Laceration * 1	0/23 (0.00%)	0	1/13 (7.69%)	1	0/15 (0.00%)	0	0/13 (0.00%)	0	1/44 (2.27%)	1
Skin abrasion * 1	0/23 (0.00%)	0	0/13 (0.00%)	0	0/15 (0.00%)	0	1/13 (7.69%)	1	1/44 (2.27%)	1
Investigations
Blood pressure decreased * 1	0/23 (0.00%)	0	0/13 (0.00%)	0	0/15 (0.00%)	0	1/13 (7.69%)	1	0/44 (0.00%)	0
Urine output decreased * 1	0/23 (0.00%)	0	0/13 (0.00%)	0	0/15 (0.00%)	0	1/13 (7.69%)	1	0/44 (0.00%)	0
Metabolism and nutrition disorders
Decreased appetite * 1	1/23 (4.35%)	1	1/13 (7.69%)	1	0/15 (0.00%)	0	1/13 (7.69%)	1	3/44 (6.82%)	3
Musculoskeletal and connective tissue disorders
Flank pain * 1	0/23 (0.00%)	0	0/13 (0.00%)	0	0/15 (0.00%)	0	1/13 (7.69%)	1	0/44 (0.00%)	0
Musculoskeletal pain * 1	0/23 (0.00%)	0	1/13 (7.69%)	2	0/15 (0.00%)	0	0/13 (0.00%)	0	1/44 (2.27%)	1
Musculoskeletal stiffness * 1	0/23 (0.00%)	0	1/13 (7.69%)	1	0/15 (0.00%)	0	0/13 (0.00%)	0	1/44 (2.27%)	1
Neck pain * 1	0/23 (0.00%)	0	1/13 (7.69%)	2	0/15 (0.00%)	0	0/13 (0.00%)	0	0/44 (0.00%)	0
Pain in extremity * 1	1/23 (4.35%)	1	0/13 (0.00%)	0	0/15 (0.00%)	0	1/13 (7.69%)	1	0/44 (0.00%)	0
Posture abnormal * 1	0/23 (0.00%)	0	0/13 (0.00%)	0	0/15 (0.00%)	0	1/13 (7.69%)	1	0/44 (0.00%)	0
Nervous system disorders
Balance disorder * 1	1/23 (4.35%)	1	0/13 (0.00%)	0	1/15 (6.67%)	1	1/13 (7.69%)	1	0/44 (0.00%)	0
Dizziness * 1	0/23 (0.00%)	0	0/13 (0.00%)	0	1/15 (6.67%)	1	2/13 (15.38%)	2	4/44 (9.09%)	4
Dyskinesia * 1	2/23 (8.70%)	2	1/13 (7.69%)	2	1/15 (6.67%)	1	3/13 (23.08%)	3	7/44 (15.91%)	7
Dystonia * 1	2/23 (8.70%)	3	0/13 (0.00%)	0	0/15 (0.00%)	0	0/13 (0.00%)	0	1/44 (2.27%)	1
Headache * 1	0/23 (0.00%)	0	2/13 (15.38%)	2	1/15 (6.67%)	1	3/13 (23.08%)	3	11/44 (25.00%)	14
Memory impairment * 1	0/23 (0.00%)	0	0/13 (0.00%)	0	0/15 (0.00%)	0	1/13 (7.69%)	1	1/44 (2.27%)	1
Myoclonus * 1	0/23 (0.00%)	0	0/13 (0.00%)	0	1/15 (6.67%)	1	0/13 (0.00%)	0	0/44 (0.00%)	0
Neuropathy peripheral * 1	0/23 (0.00%)	0	0/13 (0.00%)	0	1/15 (6.67%)	1	0/13 (0.00%)	0	1/44 (2.27%)	1
Parkinson's disease * 1	0/23 (0.00%)	0	0/13 (0.00%)	0	1/15 (6.67%)	1	0/13 (0.00%)	0	1/44 (2.27%)	1
Somnolence * 1	0/23 (0.00%)	0	0/13 (0.00%)	0	1/15 (6.67%)	1	1/13 (7.69%)	1	0/44 (0.00%)	0
Psychiatric disorders
Abnormal dreams * 1	1/23 (4.35%)	1	1/13 (7.69%)	1	1/15 (6.67%)	1	0/13 (0.00%)	0	3/44 (6.82%)	4
Aggression * 1	0/23 (0.00%)	0	0/13 (0.00%)	0	0/15 (0.00%)	0	1/13 (7.69%)	1	0/44 (0.00%)	0
Anxiety * 1	1/23 (4.35%)	1	0/13 (0.00%)	0	0/15 (0.00%)	0	0/13 (0.00%)	0	3/44 (6.82%)	3
Delusion * 1	0/23 (0.00%)	0	0/13 (0.00%)	0	0/15 (0.00%)	0	1/13 (7.69%)	1	0/44 (0.00%)	0
Depersonalisation/derealisation disorder * 1	0/23 (0.00%)	0	1/13 (7.69%)	1	0/15 (0.00%)	0	0/13 (0.00%)	0	1/44 (2.27%)	1
Depression * 1	0/23 (0.00%)	0	0/13 (0.00%)	0	1/15 (6.67%)	1	1/13 (7.69%)	1	1/44 (2.27%)	1
Dysphemia * 1	0/23 (0.00%)	0	0/13 (0.00%)	0	0/15 (0.00%)	0	1/13 (7.69%)	1	0/44 (0.00%)	0
Hallucination * 1	0/23 (0.00%)	0	0/13 (0.00%)	0	0/15 (0.00%)	0	1/13 (7.69%)	1	0/44 (0.00%)	0
Hypersexuality * 1	0/23 (0.00%)	0	0/13 (0.00%)	0	1/15 (6.67%)	1	0/13 (0.00%)	0	0/44 (0.00%)	0
Insomnia * 1	3/23 (13.04%)	3	1/13 (7.69%)	1	0/15 (0.00%)	0	1/13 (7.69%)	1	2/44 (4.55%)	2
Irritability * 1	0/23 (0.00%)	0	0/13 (0.00%)	0	0/15 (0.00%)	0	0/13 (0.00%)	0	4/44 (9.09%)	4
Rapid eye movement sleep behaviour disorder * 1	0/23 (0.00%)	0	0/13 (0.00%)	0	0/15 (0.00%)	0	1/13 (7.69%)	1	0/44 (0.00%)	0
Sleep disorder * 1	0/23 (0.00%)	0	0/13 (0.00%)	0	1/15 (6.67%)	1	1/13 (7.69%)	1	1/44 (2.27%)	2
Renal and urinary disorders
Nephrolithiasis * 1	0/23 (0.00%)	0	1/13 (7.69%)	1	0/15 (0.00%)	0	0/13 (0.00%)	0	0/44 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
Dysphonia * 1	0/23 (0.00%)	0	0/13 (0.00%)	0	0/15 (0.00%)	0	1/13 (7.69%)	1	0/44 (0.00%)	0
Vascular disorders
Flushing * 1	0/23 (0.00%)	0	1/13 (7.69%)	1	0/15 (0.00%)	0	0/13 (0.00%)	0	0/44 (0.00%)	0
Hot flush * 1	1/23 (4.35%)	1	0/13 (0.00%)	0	0/15 (0.00%)	0	1/13 (7.69%)	1	1/44 (2.27%)	1
Hypertension * 1	0/23 (0.00%)	0	0/13 (0.00%)	0	1/15 (6.67%)	1	0/13 (0.00%)	0	0/44 (0.00%)	0
Hypotension * 1	0/23 (0.00%)	0	0/13 (0.00%)	0	2/15 (13.33%)	2	0/13 (0.00%)	0	0/44 (0.00%)	0
Orthostatic hypotension * 1	0/23 (0.00%)	0	0/13 (0.00%)	0	1/15 (6.67%)	1	0/13 (0.00%)	0	2/44 (4.55%)	2
1 Term from vocabulary, MedDRA version 20.1; * Indicates events were collected by non-systematic assessment

Limitations and Caveats

The study was terminated prematurely due to insufficient efficacy and not due to safety reasons.

More Information

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.

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

Results Point of Contact

• Name/Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.
• Phone: 1-800-718-1021
• EMail: ClinicalTrials.gov_Inquiries@pfizer.com

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT02687542
• Other Study ID Numbers: B7601003; 2015-004912-39 ( EudraCT Number ); A-ROSE PD ( Other Identifier: Alias Study Number ); A-ROSE ( Other Identifier: Alias Study Number )
• First Submitted: January 29, 2016
• First Posted: February 22, 2016
• Results First Submitted: October 30, 2018
• Results First Posted: December 24, 2018
• Last Update Posted: November 23, 2020