Trial Outcomes & Findings for An Outpatient Study Of The Efficacy, Safety, And Tolerability Of PF-02545920 In The Adjunctive Treatment Of Sub-Optimally Controlled Symptoms of Schizophrenia (NCT NCT01939548)

Results Overview

The Positive and Negative Syndrome Scale (PANSS) assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS Total Score and ranges from 30 to 210; higher score indicates greater severity.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

240 participants

Primary outcome timeframe

Baseline

Results posted on

2016-08-22

Participant Flow

Participant milestones

Participant milestones
Measure	PF-02545920 5 mg BID Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).	PF-02545920 15 mg BID Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).	Placebo Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
Overall Study STARTED	78	82	80
Overall Study COMPLETED	41	33	50
Overall Study NOT COMPLETED	37	49	30

Reasons for withdrawal

Reasons for withdrawal
Measure	PF-02545920 5 mg BID Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).	PF-02545920 15 mg BID Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).	Placebo Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
Overall Study Non compliance	0	2	0
Overall Study Study Terminated by Sponsor	17	19	12
Overall Study Insufficient Clinical Response	1	0	0
Overall Study Did Not Meet Entrance Criteria	1	0	0
Overall Study Withdrawal by Subject	4	4	1
Overall Study Protocol Violation	7	6	5
Overall Study Lost to Follow-up	5	5	3
Overall Study Adverse Event	2	9	7
Overall Study Death	0	0	1
Overall Study Participant dropped	0	0	1
Overall Study Participant unwilling to continue	0	1	0
Overall Study Participant withdrew consent	0	2	0
Overall Study Did not complete follow-up	0	1	0

Baseline Characteristics

An Outpatient Study Of The Efficacy, Safety, And Tolerability Of PF-02545920 In The Adjunctive Treatment Of Sub-Optimally Controlled Symptoms of Schizophrenia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PF-02545920 5 mg BID n=78 Participants Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).	PF-02545920 15 mg BID n=82 Participants Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).	Placebo n=80 Participants Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).	Total n=240 Participants Total of all reporting groups
Age, Continuous	47.5 years STANDARD_DEVIATION 10.4 • n=5 Participants	46.3 years STANDARD_DEVIATION 9.4 • n=7 Participants	45.6 years STANDARD_DEVIATION 9.9 • n=5 Participants	46.5 years STANDARD_DEVIATION 9.9 • n=4 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	26 Participants n=7 Participants	27 Participants n=5 Participants	76 Participants n=4 Participants
Sex: Female, Male Male	55 Participants n=5 Participants	56 Participants n=7 Participants	53 Participants n=5 Participants	164 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline

Population: All participants who received study treatment.

The Positive and Negative Syndrome Scale (PANSS) assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS Total Score and ranges from 30 to 210; higher score indicates greater severity.

Outcome measures

Outcome measures
Measure	PF-02545920 5 mg BID n=78 Participants Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).	PF-02545920 15 mg BID n=82 Participants Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).	Placebo n=80 Participants Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
Positive and Negative Syndrome Scale (PANSS) Total Score at Baseline	81.7 units on a scale Standard Deviation 11.66	82.5 units on a scale Standard Deviation 11.71	80.8 units on a scale Standard Deviation 11.19

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: All participants in the Full Analysis Set (FAS, defined as all participants who received at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline measurement) who had available data for this outcome measure at Week 12.

The PANSS assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS Total Score and ranges from 30 to 210; higher score indicates greater severity.

Outcome measures

Outcome measures
Measure	PF-02545920 5 mg BID n=40 Participants Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).	PF-02545920 15 mg BID n=33 Participants Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).	Placebo n=49 Participants Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
Change From Baseline to Week 12 in PANSS Total Score	-13.1 units on a scale Standard Deviation 12.68	-16.0 units on a scale Standard Deviation 13.76	-16.7 units on a scale Standard Deviation 13.68

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: All participants who received study treatment were included in the baseline evaluation. The number of evaluable participants at Week 12 were those in the FAS with available data at Week 12 (n=number of evaluable participants at the specified time point)

The Personal and Social Performance Scale (PSP) is a validated clinician-related scale that measured personal and social functioning in the domains of: socially useful activities (eg, work and study), personal and social relationships, self-care, disturbing and aggressive behaviors. Information from the participant and the informant were utilized in determining the rating. A PSP total score was determined from the 4 domains (score range 0-100). A score between 71 and 100 indicates a mild degree of difficulty; a score between 31 and 70 indicates a moderate degree of dysfunction, and a participant with a score of 30 or less has functioning so poor he or she requires intensive supervision.

Outcome measures

Outcome measures
Measure	PF-02545920 5 mg BID n=78 Participants Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).	PF-02545920 15 mg BID n=82 Participants Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).	Placebo n=80 Participants Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
Change From Baseline to Week 12 in Personal and Social Performance Scale (PSP) Total Score Change at Week 12 (n=40, 34, 50)	6.3 units on a scale Standard Deviation 7.25	6.0 units on a scale Standard Deviation 10.12	8.7 units on a scale Standard Deviation 10.19
Change From Baseline to Week 12 in Personal and Social Performance Scale (PSP) Total Score Baseline (n=78, 82, 80)	54.3 units on a scale Standard Deviation 9.14	53.9 units on a scale Standard Deviation 10.38	52.6 units on a scale Standard Deviation 10.18

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: All participants who received study treatment were included in the baseline evaluation. At Week 12, the number of evaluable participants in the FAS were 40, 33, and 49.

The PANSS includes 3 scales and 30 items: 7 items that make up the Positive Scale (eg, delusions, conceptual disorganization, hallucinatory behavior); 7 items that make up the Negative Scale (eg, blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal); and 16 items that make up the General Psychopathology Scale (eg, somatic concern, anxiety, guilt feelings, mannerisms and posturing, motor retardation, uncooperativeness, disorientation, poor impulse control, preoccupation). Individual items are scored with values ranging from 1 to 7. Total Negative and Positive Subscale scores each range from 7 to 49; higher score indicates greater severity. Total General Psychopathology Subscale score range from 16 to 112; higher score indicates greater severity.

Outcome measures

Outcome measures
Measure	PF-02545920 5 mg BID n=78 Participants Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).	PF-02545920 15 mg BID n=82 Participants Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).	Placebo n=80 Participants Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
Change From Baseline to Week 12 in PANSS Positive, Negative, and General Subscales Positive subscale score, baseline	21.4 units on a scale Standard Deviation 4.05	21.3 units on a scale Standard Deviation 4.83	21.8 units on a scale Standard Deviation 4.07
Change From Baseline to Week 12 in PANSS Positive, Negative, and General Subscales Positive subscale score, change at Week 12	-4.2 units on a scale Standard Deviation 3.91	-3.6 units on a scale Standard Deviation 4.34	-5.3 units on a scale Standard Deviation 4.25
Change From Baseline to Week 12 in PANSS Positive, Negative, and General Subscales Negative subscale score, baseline	20.5 units on a scale Standard Deviation 4.01	20.6 units on a scale Standard Deviation 4.27	20.6 units on a scale Standard Deviation 4.30
Change From Baseline to Week 12 in PANSS Positive, Negative, and General Subscales Negative subscale score, change at Week 12	-3.0 units on a scale Standard Deviation 4.22	-3.6 units on a scale Standard Deviation 4.90	-3.7 units on a scale Standard Deviation 4.13
Change From Baseline to Week 12 in PANSS Positive, Negative, and General Subscales General subscale score, baseline	39.8 units on a scale Standard Deviation 6.96	40.7 units on a scale Standard Deviation 6.79	38.4 units on a scale Standard Deviation 6.02
Change From Baseline to Week 12 in PANSS Positive, Negative, and General Subscales General subscale score, change at Week 12	-6.0 units on a scale Standard Deviation 7.23	-8.8 units on a scale Standard Deviation 7.94	-7.7 units on a scale Standard Deviation 7.69

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: All participants who received study treatment were included in the baseline evaluation. At Week 12, the number of evaluable participants in the FAS were 40, 33, and 49.

The subscales based on Marder factors are: negative symptoms, positive symptoms, disorganized thoughts factor, uncontrolled hostility/excitement factor, and anxiety/depression factor. The symptoms are rated on a 7-point scale, with a range of 7 to 49 for negative symptoms, 8 to 56 for positive symptoms, 7 to 49 for disorganized thoughts and 4 to 28 for uncontrolled hostility/excitement and anxiety/depression. Higher scores indicate higher severity of symptoms.

Outcome measures

Outcome measures
Measure	PF-02545920 5 mg BID n=78 Participants Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).	PF-02545920 15 mg BID n=82 Participants Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).	Placebo n=80 Participants Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
Change From Baseline to Week 12 in PANSS-Derived Marder Factor Scores Anxiety/depression, baseline	10.7 units on a scale Standard Deviation 3.16	10.9 units on a scale Standard Deviation 3.03	10.0 units on a scale Standard Deviation 2.95
Change From Baseline to Week 12 in PANSS-Derived Marder Factor Scores Anxiety/depression, change at Week 12 (W12)	-1.9 units on a scale Standard Deviation 4.09	-2.4 units on a scale Standard Deviation 3.71	-2.9 units on a scale Standard Deviation 3.15
Change From Baseline to Week 12 in PANSS-Derived Marder Factor Scores Disorganized thought, baseline	17.4 units on a scale Standard Deviation 3.40	17.5 units on a scale Standard Deviation 4.11	17.5 units on a scale Standard Deviation 3.80
Change From Baseline to Week 12 in PANSS-Derived Marder Factor Scores Disorganized thought, change at W12	-2.4 units on a scale Standard Deviation 2.92	-3.9 units on a scale Standard Deviation 3.25	-2.2 units on a scale Standard Deviation 3.24
Change From Baseline to Week 12 in PANSS-Derived Marder Factor Scores Negative symptom, baseline	20.7 units on a scale Standard Deviation 4.44	20.8 units on a scale Standard Deviation 4.71	20.4 units on a scale Standard Deviation 4.62
Change From Baseline to Week 12 in PANSS-Derived Marder Factor Scores Negative symptom, change at W12	-3.4 units on a scale Standard Deviation 4.50	-4.2 units on a scale Standard Deviation 5.19	-4.4 units on a scale Standard Deviation 4.52
Change From Baseline to Week 12 in PANSS-Derived Marder Factor Scores Positive symptom, baseline	25.3 units on a scale Standard Deviation 4.72	24.9 units on a scale Standard Deviation 5.23	25.3 units on a scale Standard Deviation 4.90
Change From Baseline to Week 12 in PANSS-Derived Marder Factor Scores Positive symptom, change at W12	-4.6 units on a scale Standard Deviation 4.71	-3.6 units on a scale Standard Deviation 5.49	-5.5 units on a scale Standard Deviation 4.61
Change From Baseline to Week 12 in PANSS-Derived Marder Factor Scores Uncontrolled hostility/excitement, baseline	7.7 units on a scale Standard Deviation 2.58	8.5 units on a scale Standard Deviation 2.96	7.5 units on a scale Standard Deviation 2.65
Change From Baseline to Week 12 in PANSS-Derived Marder Factor Scores Uncontrolled hostility/excitement, change at W12	-0.8 units on a scale Standard Deviation 2.22	-1.9 units on a scale Standard Deviation 2.25	-1.6 units on a scale Standard Deviation 2.76

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: All participants who received study treatment were included in the baseline evaluation. n=number of evaluable participants in the FAS at the specified time point.

CGI-S: 7-point clinician-rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. Change: score at observation minus score at baseline.

Outcome measures

Outcome measures
Measure	PF-02545920 5 mg BID n=78 Participants Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).	PF-02545920 15 mg BID n=82 Participants Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).	Placebo n=80 Participants Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
Change From Baseline to Week 12 in Clinical Global Impression of Severity (CGI-S) Baseline (n=78, 82, 80)	4.3 units on a scale Standard Deviation 0.50	4.3 units on a scale Standard Deviation 0.45	4.4 units on a scale Standard Deviation 0.54
Change From Baseline to Week 12 in Clinical Global Impression of Severity (CGI-S) Change at Week 12 (n=40, 34, 50)	-0.8 units on a scale Standard Deviation 0.78	-0.7 units on a scale Standard Deviation 0.59	-0.8 units on a scale Standard Deviation 0.74

SECONDARY outcome

Timeframe: Week 12

Population: Participants in the FAS who were evaluable for this outcome measure at Week 12.

CGI-I: 7-point clinician-rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.

Outcome measures

Outcome measures
Measure	PF-02545920 5 mg BID n=40 Participants Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).	PF-02545920 15 mg BID n=34 Participants Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).	Placebo n=50 Participants Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
Clinical Global Impression - Improvement (CGI-I) Total Score at Week 12	2.9 units on a scale Standard Deviation 1.00	2.7 units on a scale Standard Deviation 0.96	2.9 units on a scale Standard Deviation 0.88

SECONDARY outcome

Timeframe: Baseline up to 7-10 days after last dose of study drug (follow-up)

Population: All participants who received at least 1 dose of study drug were included in the AE summarization/analysis.

An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs comprised both SAEs and non-SAEs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse events (TEAEs) were defined as newly occurring AEs or those worsening after first dose.

Outcome measures

Outcome measures
Measure	PF-02545920 5 mg BID n=78 Participants Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).	PF-02545920 15 mg BID n=82 Participants Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).	Placebo n=80 Participants Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations Due to Adverse Events (AEs) Participants with TEAEs	41 participants	53 participants	51 participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations Due to Adverse Events (AEs) Participants with SAEs	2 participants	0 participants	6 participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations Due to Adverse Events (AEs) Participants discontinued permanently due to AEs	2 participants	9 participants	8 participants

SECONDARY outcome

Timeframe: Screening up to 7-10 days after last dose of study drug (follow-up)

Population: All participants who received at least 1 dose of study drug were included in the safety analyses. n=number of evaluable participants for each specified vital sign parameter.

Categorical summarization criteria in vital signs included: sitting, supine, and standing systolic blood pressure (SBP) of less than (\<)90 millimeters of mercury (mm Hg) or change in sitting, supine and standing SBP of more than or equal to (\>=)30 mm Hg; supine, sitting, and standing diastolic blood pressure (DBP) of \<50 mm Hg or change in sitting, supine, and standing DBP of \>=20 mm Hg; supine and sitting pulse rate of \<40 or more than (\>)120 beats per minute (bpm); and standing pulse rate of \<40 or \>140 bpm.

Outcome measures

Outcome measures
Measure	PF-02545920 5 mg BID n=78 Participants Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).	PF-02545920 15 mg BID n=82 Participants Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).	Placebo n=80 Participants Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria Increase in supine SBP >=30 mmHg (n=75,81,79)	3 participants	1 participants	3 participants
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria Supine SBP <90 mmHg (n=78,82,80)	0 participants	0 participants	0 participants
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria Sitting SBP <90 mmHg (n=74,79,79)	0 participants	1 participants	1 participants
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria Standing SBP <90 mmHg (n=78,82,80)	0 participants	2 participants	1 participants
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria Supine DBP <50 mmHg (n=78,82,80)	0 participants	1 participants	0 participants
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria Sitting DBP <50 mmHg (n=74,79,79)	0 participants	0 participants	0 participants
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria Standing DBP <50 mmHg (n=78,82,80)	0 participants	0 participants	0 participants
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria Supine pulse rate <40 or >120 bpm (n=78,82,80)	0 participants	0 participants	0 participants
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria Sitting pulse rate <40 or >120 bpm (n=74,79,79)	0 participants	0 participants	0 participants
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria Standing pulse rate <40 bpm (n=78,82,80)	0 participants	1 participants	0 participants
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria Standing pulse rate >140 bpm (n=78,82,80)	0 participants	0 participants	0 participants
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria Increase in sitting SBP >=30 mmHg (n=73,79,79)	0 participants	2 participants	2 participants
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria Increase in standing SBP >=30 mmHg (n=75,81,79)	3 participants	2 participants	2 participants
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria Increase in supine DBP >=20 mmHg (n=75,81,79)	3 participants	1 participants	4 participants
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria Increase in sitting DBP >=20 mmHg (n=73,79,79)	2 participants	2 participants	5 participants
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria Increase in standing DBP >=20 mmHg (n=75,81,79)	6 participants	2 participants	1 participants
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria Decrease in supine SBP >=30 mmHg (n=75,81,79)	1 participants	4 participants	1 participants
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria Decrease in sitting SBP >=30 mmHg (n=73,79,79)	2 participants	2 participants	2 participants
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria Decrease in standing SBP >=30 mmHg (n=75,81,79)	1 participants	2 participants	1 participants
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria Decrease in supine DBP >=20 mmHg (n=75,81,79)	3 participants	0 participants	3 participants
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria Decrease in sitting DBP >=20 mmHg (n=73,79,79)	3 participants	8 participants	2 participants
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria Decrease in standing DBP >=20 mmHg (n=75,81,79)	4 participants	0 participants	3 participants

SECONDARY outcome

Timeframe: Screening/Baseline up to Week 12 (or Early Termination)

Population: All participants who received at least 1 dose of study drug were included in the safety analyses. n=number of evaluable participants for each specified ECG parameter.

Criteria for ECG (12-lead) values meeting categorical summarization criteria were: the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization (PR interval \>=300 milliseconds (msec) and increase from baseline \>=25/50%; time from the beginning of the electrocardiogram Q wave to the end of the S wave corresponding to ventricular depolarization (QRS) interval \>=140 msec and increase of \>=50%; the beginning of the Q wave to the end of the T wave corresponding to electrical systole (QT) interval corrected using the Fridericia formula (QTcF) of 450 to \<480 msec, 480 to \<500 msec and \>=500 msec, or an increase of 30 to \<60 msec or \>=60 msec.

Outcome measures

Outcome measures
Measure	PF-02545920 5 mg BID n=78 Participants Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).	PF-02545920 15 mg BID n=82 Participants Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).	Placebo n=80 Participants Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
Number of Participants With Electrocardiogram (ECG) Values Meeting Categorical Summarization Criteria PR interval >=300 msec (n=78,82,80)	0 participants	0 participants	0 participants
Number of Participants With Electrocardiogram (ECG) Values Meeting Categorical Summarization Criteria QRS >=140 msec (n=78,82,80)	1 participants	0 participants	0 participants
Number of Participants With Electrocardiogram (ECG) Values Meeting Categorical Summarization Criteria QTcF 450 to <480 msec (n=78,82,80)	5 participants	6 participants	2 participants
Number of Participants With Electrocardiogram (ECG) Values Meeting Categorical Summarization Criteria QTcF >=500 msec (n=78,82,80)	0 participants	0 participants	0 participants
Number of Participants With Electrocardiogram (ECG) Values Meeting Categorical Summarization Criteria PR interval increase >=25/50% (n=72,81,77)	0 participants	0 participants	0 participants
Number of Participants With Electrocardiogram (ECG) Values Meeting Categorical Summarization Criteria QRS increase >=50% (n=72,81,77)	1 participants	0 participants	0 participants
Number of Participants With Electrocardiogram (ECG) Values Meeting Categorical Summarization Criteria QTcF increase 30 to <60 msec (n=72,81,77)	3 participants	1 participants	3 participants
Number of Participants With Electrocardiogram (ECG) Values Meeting Categorical Summarization Criteria QTcF increase >=60 msec (n=72,81,77)	0 participants	0 participants	1 participants
Number of Participants With Electrocardiogram (ECG) Values Meeting Categorical Summarization Criteria QTcF 480 to <500 msec (n=78,82,80)	0 participants	0 participants	1 participants

SECONDARY outcome

Timeframe: Screening up to Day 84

Population: All participants who received at least 1 dose of study treatment.

The effects of PF-02545920 on body weight were evaluated. The number of participants with changes from baseline in body weight of \>=7% were tabulated and summarized.

Outcome measures

Outcome measures
Measure	PF-02545920 5 mg BID n=78 Participants Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).	PF-02545920 15 mg BID n=82 Participants Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).	Placebo n=80 Participants Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
Number of Participants With Weight Change >=7% Increase from baseline >=7%	2 participants	1 participants	3 participants
Number of Participants With Weight Change >=7% Decrease from baseline >=7%	1 participants	7 participants	3 participants

SECONDARY outcome

Timeframe: Baseline and Week 12 or Early Termination

Population: All participants who received at least 1 dose of study drug and who were evaluable for physical examinations.

A complete physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems.

Outcome measures

Outcome measures
Measure	PF-02545920 5 mg BID n=72 Participants Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).	PF-02545920 15 mg BID n=77 Participants Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).	Placebo n=74 Participants Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
Number of Participants With New/Intensified Physical Examination Findings From Baseline by Body Site Ears	0 participants	0 participants	0 participants
Number of Participants With New/Intensified Physical Examination Findings From Baseline by Body Site Eyes	1 participants	0 participants	0 participants
Number of Participants With New/Intensified Physical Examination Findings From Baseline by Body Site Gastrointestinal	0 participants	0 participants	1 participants
Number of Participants With New/Intensified Physical Examination Findings From Baseline by Body Site General Appearance	1 participants	0 participants	1 participants
Number of Participants With New/Intensified Physical Examination Findings From Baseline by Body Site Head	1 participants	0 participants	1 participants
Number of Participants With New/Intensified Physical Examination Findings From Baseline by Body Site Heart	0 participants	1 participants	0 participants
Number of Participants With New/Intensified Physical Examination Findings From Baseline by Body Site Lungs	0 participants	0 participants	0 participants
Number of Participants With New/Intensified Physical Examination Findings From Baseline by Body Site Lymph nodes	0 participants	0 participants	0 participants
Number of Participants With New/Intensified Physical Examination Findings From Baseline by Body Site Mouth	0 participants	1 participants	1 participants
Number of Participants With New/Intensified Physical Examination Findings From Baseline by Body Site Musculoskeletal	2 participants	1 participants	0 participants
Number of Participants With New/Intensified Physical Examination Findings From Baseline by Body Site Neurological	0 participants	0 participants	1 participants
Number of Participants With New/Intensified Physical Examination Findings From Baseline by Body Site Nose	0 participants	0 participants	0 participants
Number of Participants With New/Intensified Physical Examination Findings From Baseline by Body Site Skin	1 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Screening up to Week 12/Early Termination and 7-10 days after last dose of study drug (hematology only)

Population: All participants who had received at least 1 dose of study drug and who were evaluable for laboratory abnormalities.

Number of participants with laboratory test abnormalities without regard to baseline abnormality. Laboratory test parameters included hematology, liver function, renal function, lipids, electrolytes, hormones (prolactin), clinical chemistry, and urinalysis (dipstick and microscopy).

Outcome measures

Outcome measures
Measure	PF-02545920 5 mg BID n=75 Participants Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).	PF-02545920 15 mg BID n=81 Participants Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).	Placebo n=78 Participants Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
Number of Participants With Laboratory Test Abnormalities	46 participants	54 participants	49 participants

SECONDARY outcome

Timeframe: Baseline up to 7-10 days after last dose of study drug (follow-up)

Population: All participants who received at least 1 dose of study drug were included in the AE summarization/analysis.

EPS AEs consisted of oromandibular dystonia, extrapyramidal disorder, akathisia, dyskinesia, and tremor.

Outcome measures

Outcome measures
Measure	PF-02545920 5 mg BID n=78 Participants Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).	PF-02545920 15 mg BID n=82 Participants Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).	Placebo n=80 Participants Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
Number of Participants With Extrapyramidal Motor System (EPS) AEs Oromandibular dystonia	0 participants	2 participants	0 participants
Number of Participants With Extrapyramidal Motor System (EPS) AEs Extrapyramidal disorder	0 participants	1 participants	0 participants
Number of Participants With Extrapyramidal Motor System (EPS) AEs Akathisia	0 participants	2 participants	0 participants
Number of Participants With Extrapyramidal Motor System (EPS) AEs Dyskinesia	0 participants	2 participants	0 participants
Number of Participants With Extrapyramidal Motor System (EPS) AEs Tremor	0 participants	3 participants	0 participants

SECONDARY outcome

Timeframe: Baseline; Weeks 6 and 12

Population: All participants who had received at least 1 dose of study drug and who had available data for metabolic parameters. n=number of evaluable participants at the specified time points.

Choleseterol, TG, glycosylated hemoglobin (HbA1c), LDL, HDL, insulin, and prolactin were a part of the laboratory tests done (metabolic tests).

Outcome measures

Outcome measures
Measure	PF-02545920 5 mg BID n=78 Participants Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).	PF-02545920 15 mg BID n=81 Participants Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).	Placebo n=78 Participants Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
Change From Baseline in Cholesterol, Triglycerides (TG), Low-Density Lipoprotein (LDL), and High-Density Lipoprotein (HDL) at Weeks 6 and 12 Cholesterol, baseline (n=78,81,78)	197.4 milligram (mg)/deciliter (dL) Standard Deviation 41.84	196.9 milligram (mg)/deciliter (dL) Standard Deviation 39.08	188.6 milligram (mg)/deciliter (dL) Standard Deviation 42.42
Change From Baseline in Cholesterol, Triglycerides (TG), Low-Density Lipoprotein (LDL), and High-Density Lipoprotein (HDL) at Weeks 6 and 12 Cholesterol, change at Week 6 (n=53,45,58)	-2.5 milligram (mg)/deciliter (dL) Standard Deviation 25.03	-6.2 milligram (mg)/deciliter (dL) Standard Deviation 24.89	-1.1 milligram (mg)/deciliter (dL) Standard Deviation 22.82
Change From Baseline in Cholesterol, Triglycerides (TG), Low-Density Lipoprotein (LDL), and High-Density Lipoprotein (HDL) at Weeks 6 and 12 Cholesterol, change at Week 12 (n=71,67,65)	-5.3 milligram (mg)/deciliter (dL) Standard Deviation 31.56	-8.9 milligram (mg)/deciliter (dL) Standard Deviation 25.49	0.3 milligram (mg)/deciliter (dL) Standard Deviation 24.38
Change From Baseline in Cholesterol, Triglycerides (TG), Low-Density Lipoprotein (LDL), and High-Density Lipoprotein (HDL) at Weeks 6 and 12 TG, baseline (n=78,81,78)	126.7 milligram (mg)/deciliter (dL) Standard Deviation 82.31	125.3 milligram (mg)/deciliter (dL) Standard Deviation 62.13	143.0 milligram (mg)/deciliter (dL) Standard Deviation 121.41
Change From Baseline in Cholesterol, Triglycerides (TG), Low-Density Lipoprotein (LDL), and High-Density Lipoprotein (HDL) at Weeks 6 and 12 TG, change at Week 6 (n=53,45,58)	7.7 milligram (mg)/deciliter (dL) Standard Deviation 69.01	-15.0 milligram (mg)/deciliter (dL) Standard Deviation 59.10	3.1 milligram (mg)/deciliter (dL) Standard Deviation 68.39
Change From Baseline in Cholesterol, Triglycerides (TG), Low-Density Lipoprotein (LDL), and High-Density Lipoprotein (HDL) at Weeks 6 and 12 TG, change at Week 12 (n=71,67,65)	-3.7 milligram (mg)/deciliter (dL) Standard Deviation 57.77	-10.2 milligram (mg)/deciliter (dL) Standard Deviation 60.46	7.8 milligram (mg)/deciliter (dL) Standard Deviation 67.02
Change From Baseline in Cholesterol, Triglycerides (TG), Low-Density Lipoprotein (LDL), and High-Density Lipoprotein (HDL) at Weeks 6 and 12 LDL, baseline (n=77,81,76)	113.6 milligram (mg)/deciliter (dL) Standard Deviation 34.80	115.1 milligram (mg)/deciliter (dL) Standard Deviation 35.22	108.3 milligram (mg)/deciliter (dL) Standard Deviation 31.88
Change From Baseline in Cholesterol, Triglycerides (TG), Low-Density Lipoprotein (LDL), and High-Density Lipoprotein (HDL) at Weeks 6 and 12 LDL, change at Week 6 (n=52,45,56)	-1.5 milligram (mg)/deciliter (dL) Standard Deviation 19.19	-1.1 milligram (mg)/deciliter (dL) Standard Deviation 21.97	-1.5 milligram (mg)/deciliter (dL) Standard Deviation 19.57
Change From Baseline in Cholesterol, Triglycerides (TG), Low-Density Lipoprotein (LDL), and High-Density Lipoprotein (HDL) at Weeks 6 and 12 LDL, change at Week 12 (n=70,67,61)	-2.8 milligram (mg)/deciliter (dL) Standard Deviation 24.29	-7.3 milligram (mg)/deciliter (dL) Standard Deviation 20.87	0.5 milligram (mg)/deciliter (dL) Standard Deviation 20.88
Change From Baseline in Cholesterol, Triglycerides (TG), Low-Density Lipoprotein (LDL), and High-Density Lipoprotein (HDL) at Weeks 6 and 12 HDL, baseline (n=78,81,78)	57.8 milligram (mg)/deciliter (dL) Standard Deviation 19.06	56.7 milligram (mg)/deciliter (dL) Standard Deviation 15.17	51.5 milligram (mg)/deciliter (dL) Standard Deviation 13.28
Change From Baseline in Cholesterol, Triglycerides (TG), Low-Density Lipoprotein (LDL), and High-Density Lipoprotein (HDL) at Weeks 6 and 12 HDL, change at Week 6 (n=53,45,58)	-2.7 milligram (mg)/deciliter (dL) Standard Deviation 8.71	-2.1 milligram (mg)/deciliter (dL) Standard Deviation 8.41	-0.2 milligram (mg)/deciliter (dL) Standard Deviation 5.83
Change From Baseline in Cholesterol, Triglycerides (TG), Low-Density Lipoprotein (LDL), and High-Density Lipoprotein (HDL) at Weeks 6 and 12 HDL, change at Week 12 (n=71,67,65)	-1.5 milligram (mg)/deciliter (dL) Standard Deviation 10.22	0.5 milligram (mg)/deciliter (dL) Standard Deviation 7.46	0.8 milligram (mg)/deciliter (dL) Standard Deviation 7.26

SECONDARY outcome

Timeframe: Baseline; Weeks 6 and 12

Population: All participants who had received at least 1 dose of study drug and who had available data for metabolic parameters. n=number of evaluable participants at the specified time points.

Choleseterol, TG, HbA1c, LDL, HDL, insulin, and prolactin were a part of the laboratory tests done (metabolic tests).

Outcome measures

Outcome measures
Measure	PF-02545920 5 mg BID n=78 Participants Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).	PF-02545920 15 mg BID n=81 Participants Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).	Placebo n=78 Participants Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Weeks 6 and 12 Change at Week 12 (n=70,67,65)	-0.05 percent Standard Deviation 0.278	-0.07 percent Standard Deviation 0.305	-0.07 percent Standard Deviation 0.314
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Weeks 6 and 12 Baseline (n=78,81,77)	5.70 percent Standard Deviation 0.638	5.74 percent Standard Deviation 0.619	5.70 percent Standard Deviation 0.651
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Weeks 6 and 12 Change at Week 6 (n=53,45,58)	-0.04 percent Standard Deviation 0.321	0.00 percent Standard Deviation 0.234	0.01 percent Standard Deviation 0.290

SECONDARY outcome

Timeframe: Baseline; Weeks 6 and 12

Population: All participants who had received at least 1 dose of study drug and who had available data for metabolic parameters. n=number of evaluable participants at the specified time points.

Choleseterol, TG, HbA1c, LDL, HDL, insulin, and prolactin were a part of the laboratory tests done (metabolic tests).

Outcome measures

Outcome measures
Measure	PF-02545920 5 mg BID n=78 Participants Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).	PF-02545920 15 mg BID n=81 Participants Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).	Placebo n=78 Participants Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
Change From Baseline in Insulin at Weeks 6 and 12 Baseline (n=74,80,78)	9.19 micro international unit/milliliter Standard Deviation 7.907	9.78 micro international unit/milliliter Standard Deviation 8.902	9.53 micro international unit/milliliter Standard Deviation 7.575
Change From Baseline in Insulin at Weeks 6 and 12 Change at Week 6 (n=48,48,62)	4.94 micro international unit/milliliter Standard Deviation 16.755	3.04 micro international unit/milliliter Standard Deviation 16.933	3.02 micro international unit/milliliter Standard Deviation 14.157
Change From Baseline in Insulin at Weeks 6 and 12 Change at Week 12 (n=67,67,69)	7.40 micro international unit/milliliter Standard Deviation 26.838	1.29 micro international unit/milliliter Standard Deviation 9.230	1.30 micro international unit/milliliter Standard Deviation 9.399

SECONDARY outcome

Timeframe: Baseline; Weeks 6 and 12

Population: All participants who had received at least 1 dose of study drug and who had available data for metabolic parameters. n=number of evaluable participants at the specified time points.

Choleseterol, TG, HbA1c, LDL, HDL, insulin, and prolactin were a part of the laboratory tests done (metabolic tests).

Outcome measures

Outcome measures
Measure	PF-02545920 5 mg BID n=78 Participants Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).	PF-02545920 15 mg BID n=81 Participants Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).	Placebo n=78 Participants Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
Change From Baseline in Prolactin at Weeks 6 and 12 Baseline (n=78,81,77)	13.71 nanogram (ng)/milliliter Standard Deviation 18.954	13.29 nanogram (ng)/milliliter Standard Deviation 17.709	12.51 nanogram (ng)/milliliter Standard Deviation 13.597
Change From Baseline in Prolactin at Weeks 6 and 12 Change at Week 6 (n=52,45,57)	0.27 nanogram (ng)/milliliter Standard Deviation 6.410	2.65 nanogram (ng)/milliliter Standard Deviation 12.080	0.99 nanogram (ng)/milliliter Standard Deviation 9.074
Change From Baseline in Prolactin at Weeks 6 and 12 Change at Week 12 (n=70,68,64)	0.04 nanogram (ng)/milliliter Standard Deviation 8.834	2.65 nanogram (ng)/milliliter Standard Deviation 15.786	0.01 nanogram (ng)/milliliter Standard Deviation 8.925

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: All participants who received at least 1 dose of study drug. n=number of evaluable participants for each parameter at the specified time points.

The ESRS-A is a 28-item instrument designed to facilitate standardized observations of parkinsonism, dystonia, dyskinesia, and akathisia. Ratings were determined through a combination of clinical interview and a motor examination. Scores were divided into individual domain scores and clinical global impression scores (CGI-S). Scores started from 0 (normal) to 6 (0 to 8 for CGI-S), with higher scores indicating greater severity.

Outcome measures

SECONDARY outcome

Timeframe: Active treatment period (Weeks 1 to 12/Early Termination)

Population: All participants who received at least 1 dose of study drug.

The MDBS-D quantified the dystonia burden during the active treatment period. For an individual participant, MDBS-D took into account all treatment-emergent dystonia events and was defined as a combination of the severity of the AE due to dystonia, AE duration, prescribed concomitant medication, and the total number of days the study treatment was received. Scores for the MDBS-D ranged from 0 (no dystonia events) to 4.5, with higher scores indicating greater dystonia burden.

Outcome measures

Outcome measures
Measure	PF-02545920 5 mg BID n=78 Participants Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).	PF-02545920 15 mg BID n=82 Participants Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).	Placebo n=80 Participants Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
Absolute Values of Movement Disorder Burden Score - Dystonia (MDBS-D) Over Active Treatment Period	0.00 units on a scale Standard Deviation 0.000	0.02 units on a scale Standard Deviation 0.175	0.00 units on a scale Standard Deviation 0.000

SECONDARY outcome

Timeframe: Baseline up to 7-10 days after last dose of study drug

Population: All participants who had received at least 1 dose of study drug.

C-SSRS assessed whether participant experienced the following: completed suicide (Category 1), suicide attempt (Category 2; response of "Yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior (Category 3; "Yes" on "preparatory acts or behavior"), suicidal ideation (Category 4; "Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (Category 7; "Yes" on "Has subject engaged in non-suicidal self-injurious behavior").

Outcome measures

Outcome measures
Measure	PF-02545920 5 mg BID n=78 Participants Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).	PF-02545920 15 mg BID n=82 Participants Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).	Placebo n=80 Participants Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
Overall Number of Participants With Positive Responses to Categories on the Columbia Suicide Severity Rating Scale (C-SSRS) Category 1	0 participants	0 participants	0 participants
Overall Number of Participants With Positive Responses to Categories on the Columbia Suicide Severity Rating Scale (C-SSRS) Category 2	0 participants	0 participants	0 participants
Overall Number of Participants With Positive Responses to Categories on the Columbia Suicide Severity Rating Scale (C-SSRS) Category 3	0 participants	0 participants	0 participants
Overall Number of Participants With Positive Responses to Categories on the Columbia Suicide Severity Rating Scale (C-SSRS) Category 4	1 participants	3 participants	1 participants
Overall Number of Participants With Positive Responses to Categories on the Columbia Suicide Severity Rating Scale (C-SSRS) Category 7	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Days 14, 28, 42, 56, 70, 84/Early Termination

Population: Summary PK analyses were not planned or performed due to sparse PK sampling.

Pharmacokinetic (PK) samples were collected at varying times relative to drug dosing whenever participants could be scheduled for study visits (sparse PK sampling). Thus, because of the variable time between the last dose and the collection of the PK samples, typical summary PK analyses were not planned or described in the study protocol and are not available. The study protocol analysis section specified that the sparse sampled PK data might be pooled with PK data from previous PF-02545920 clinical studies, however the study results did not support conducting those analyses.

Outcome measures

Outcome data not reported

Adverse Events

PF-02545920 5 mg BID

Serious events: 2 serious events

Other events: 20 other events

Deaths: 0 deaths

PF-02545920 15 mg BID

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Placebo

Serious events: 6 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	PF-02545920 5 mg BID n=78 participants at risk Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).	PF-02545920 15 mg BID n=82 participants at risk Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).	Placebo n=80 participants at risk Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
Cardiac disorders Acute myocardial infarction	1.3% 1/78 All treated participants were analyzed for AEs. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/82 All treated participants were analyzed for AEs. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/80 All treated participants were analyzed for AEs. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/78 All treated participants were analyzed for AEs. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/82 All treated participants were analyzed for AEs. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	1.2% 1/80 All treated participants were analyzed for AEs. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Alcohol poisoning	0.00% 0/78 All treated participants were analyzed for AEs. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/82 All treated participants were analyzed for AEs. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	1.2% 1/80 All treated participants were analyzed for AEs. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Injury	0.00% 0/78 All treated participants were analyzed for AEs. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/82 All treated participants were analyzed for AEs. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	1.2% 1/80 All treated participants were analyzed for AEs. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Toxicity to various agents	0.00% 0/78 All treated participants were analyzed for AEs. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/82 All treated participants were analyzed for AEs. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	1.2% 1/80 All treated participants were analyzed for AEs. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma	0.00% 0/78 All treated participants were analyzed for AEs. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/82 All treated participants were analyzed for AEs. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	1.2% 1/80 All treated participants were analyzed for AEs. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Paranoia	1.3% 1/78 All treated participants were analyzed for AEs. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/82 All treated participants were analyzed for AEs. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/80 All treated participants were analyzed for AEs. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Psychotic disorder	0.00% 0/78 All treated participants were analyzed for AEs. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/82 All treated participants were analyzed for AEs. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	1.2% 1/80 All treated participants were analyzed for AEs. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Suicide attempt	0.00% 0/78 All treated participants were analyzed for AEs. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/82 All treated participants were analyzed for AEs. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	1.2% 1/80 All treated participants were analyzed for AEs. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.

Other adverse events

Other adverse events
Measure	PF-02545920 5 mg BID n=78 participants at risk Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).	PF-02545920 15 mg BID n=82 participants at risk Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).	Placebo n=80 participants at risk Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
Nervous system disorders Headache	6.4% 5/78 All treated participants were analyzed for AEs. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	1.2% 1/82 All treated participants were analyzed for AEs. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.5% 6/80 All treated participants were analyzed for AEs. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Dry mouth	5.1% 4/78 All treated participants were analyzed for AEs. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	4.9% 4/82 All treated participants were analyzed for AEs. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	3.8% 3/80 All treated participants were analyzed for AEs. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Nausea	2.6% 2/78 All treated participants were analyzed for AEs. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	4.9% 4/82 All treated participants were analyzed for AEs. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	6.2% 5/80 All treated participants were analyzed for AEs. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Vomiting	5.1% 4/78 All treated participants were analyzed for AEs. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	1.2% 1/82 All treated participants were analyzed for AEs. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	3.8% 3/80 All treated participants were analyzed for AEs. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Upper respiratory tract infection	1.3% 1/78 All treated participants were analyzed for AEs. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	4.9% 4/82 All treated participants were analyzed for AEs. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.5% 6/80 All treated participants were analyzed for AEs. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders Sedation	5.1% 4/78 All treated participants were analyzed for AEs. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.3% 6/82 All treated participants were analyzed for AEs. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	8.8% 7/80 All treated participants were analyzed for AEs. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders Somnolence	6.4% 5/78 All treated participants were analyzed for AEs. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	9.8% 8/82 All treated participants were analyzed for AEs. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.5% 2/80 All treated participants were analyzed for AEs. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER

Measure	PF-02545920 5 mg BID n=78 Participants Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).	PF-02545920 15 mg BID n=82 Participants Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).	Placebo n=80 Participants Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
Change From Baseline to Week 12 on the Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A) Parkinsonism, baseline (n=78,82,80)	0.5 units on a scale Standard Deviation 1.70	0.8 units on a scale Standard Deviation 1.82	0.2 units on a scale Standard Deviation 0.69
Change From Baseline to Week 12 on the Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A) Parkinsonism, change at Week 12 (W12) (n=43,38,53)	-0.3 units on a scale Standard Deviation 1.77	0.1 units on a scale Standard Deviation 2.01	-0.0 units on a scale Standard Deviation 0.44
Change From Baseline to Week 12 on the Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A) Dystonia, baseline (n=78,82,80)	0.1 units on a scale Standard Deviation 0.27	0.0 units on a scale Standard Deviation 0.00	0.0 units on a scale Standard Deviation 0.11
Change From Baseline to Week 12 on the Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A) Dyskinesia, change at W12 (n=43,38,53)	-0.0 units on a scale Standard Deviation 0.21	0.0 units on a scale Standard Deviation 0.00	0.2 units on a scale Standard Deviation 0.66
Change From Baseline to Week 12 on the Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A) Dystonia, change at W12 (n=43,38,53)	-0.0 units on a scale Standard Deviation 0.21	0.1 units on a scale Standard Deviation 0.23	0.0 units on a scale Standard Deviation 0.00
Change From Baseline to Week 12 on the Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A) Dyskinesia, baseline (n=78,82,80)	0.1 units on a scale Standard Deviation 0.50	0.1 units on a scale Standard Deviation 0.46	0.2 units on a scale Standard Deviation 0.62
Change From Baseline to Week 12 on the Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A) Akathisia, baseline (n=78,82,80)	0.3 units on a scale Standard Deviation 0.87	0.3 units on a scale Standard Deviation 0.68	0.2 units on a scale Standard Deviation 0.83
Change From Baseline to Week 12 on the Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A) Akathisia, change at W12 (n=43,38,53)	-0.1 units on a scale Standard Deviation 0.54	0.0 units on a scale Standard Deviation 0.97	-0.1 units on a scale Standard Deviation 1.02
Change From Baseline to Week 12 on the Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A) CGI-S Parkinsonism, baseline (n=78,82,80)	0.2 units on a scale Standard Deviation 0.45	0.3 units on a scale Standard Deviation 0.68	0.1 units on a scale Standard Deviation 0.33
Change From Baseline to Week 12 on the Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A) CGI-S Parkinsonism, change at W12 (n=43,38,53)	-0.1 units on a scale Standard Deviation 0.34	0.1 units on a scale Standard Deviation 0.73	0.0 units on a scale Standard Deviation 0.20
Change From Baseline to Week 12 on the Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A) CGI-S Dystonia, baseline (n=78,82,80)	0.1 units on a scale Standard Deviation 0.25	0.0 units on a scale Standard Deviation 0.00	0.0 units on a scale Standard Deviation 0.11
Change From Baseline to Week 12 on the Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A) CGI-S Dystonia, change at W12 (n=43,38,53)	-0.1 units on a scale Standard Deviation 0.26	0.0 units on a scale Standard Deviation 0.16	0.0 units on a scale Standard Deviation 0.20
Change From Baseline to Week 12 on the Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A) CGI-S Dyskinesia, baseline (n=78,82,80)	0.1 units on a scale Standard Deviation 0.27	0.1 units on a scale Standard Deviation 0.29	0.1 units on a scale Standard Deviation 0.39
Change From Baseline to Week 12 on the Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A) CGI-S Dyskinesia, change at W12 (n=43,38,53)	-0.0 units on a scale Standard Deviation 0.15	0.0 units on a scale Standard Deviation 0.00	0.1 units on a scale Standard Deviation 0.41
Change From Baseline to Week 12 on the Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A) CGI-S Akathisia, baseline (n=78,82,80)	0.2 units on a scale Standard Deviation 0.46	0.1 units on a scale Standard Deviation 0.35	0.1 units on a scale Standard Deviation 0.43
Change From Baseline to Week 12 on the Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A) CGI-S Akathisia, change at W12 (n=43,38,53)	-0.1 units on a scale Standard Deviation 0.37	-0.0 units on a scale Standard Deviation 0.54	-0.1 units on a scale Standard Deviation 0.53