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Trial record 5 of 11 for:    PF-06649751

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02687542
Recruitment Status : Terminated (Terminated 25Sep17 due to insufficient efficacy. Not due to safety reasons.)
First Posted : February 22, 2016
Results First Posted : December 24, 2018
Last Update Posted : December 24, 2018
Sponsor:
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
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
Hide 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
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
Hide 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
Hide 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%
1.Primary Outcome
Title Change From Baseline in Daily OFF Time at Week 10
Hide 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).
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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
Hide 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).
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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).
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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%
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
Hide 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%)    
Hide 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
Hide 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
The study was terminated prematurely due to insufficient efficacy and not due to safety reasons.
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
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
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: December 24, 2018