An Outpatient Study Of The Efficacy, Safety, And Tolerabi... | NCT01939548

Label	Type	Intervention Names
PF-02545920 (5mg)	Experimental	Drug: PF-02545920
Placebo	Placebo Comparator	Drug: Placebo
PF-02545920 (15mg)	Experimental	Drug: PF-02545920

Name	Type	Description	Arm Group Labels	Other Names
PF-02545920	Drug	PF-02545920 2 mg BID x 7 days, then 5 mg BID until the Week 12 visit	PF-02545920 (5mg)

Measure	Description	Time Frame
Positive and Negative Syndrome Scale (PANSS) Total Score at Baseline	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.	Baseline
Change From Baseline to Week 12 in PANSS Total Score	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.	Baseline, Week 12

Measure	Description	Time Frame
Change From Baseline to Week 12 in Personal and Social Performance Scale (PSP) Total Score	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.

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Birmingham Psychiatry Pharmaceutical Studies, Inc.		Birmingham	Alabama	35226	United States
Woodland International Research Group, INC

PubMed Identifier	Type	Citation	Retractions
25554563	Derived	Targum SD, Cara Pendergrass J, Toner C, Zumpano L, Rauh P, DeMartinis N. Impact of BPRS interview length on ratings reliability in a schizophrenia trial. Eur Neuropsychopharmacol. 2015 Mar;25(3):312-8. doi: 10.1016/j.euroneuro.2014.11.023. Epub 2014 Dec 13.

Label	URL
To obtain contact information for a study center near you, click here.	View source

ID	Title	Description
FG000	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).

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Positive and Negative Syndrome Scale (PANSS) Total Score at Baseline

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.

All participants who received study treatment.

Posted

Mean

Standard Deviation

units on a scale

Baseline

ID	Title	Description
OG000	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).
OG001	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).
OG002	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).

Units	Counts
Participants	OG00078 OG00182 OG00280

Title

Denominators

Categories

Title	Measurements
	OG00081.7± 11.66 OG00182.5± 11.71 OG00280.8± 11.19

Primary

Change From Baseline to Week 12 in PANSS Total Score

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.

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.

Posted

Mean

Standard Deviation

units on a scale

Baseline, Week 12

ID	Title	Description
OG000	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).
OG001	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).

Secondary

Change From Baseline to Week 12 in Personal and Social Performance Scale (PSP) Total Score

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.

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)

Posted

Mean

Standard Deviation

units on a scale

Baseline, Week 12

ID	Title	Description
OG000	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).
OG001	PF-02545920 15 mg BID

Secondary

Change From Baseline to Week 12 in PANSS Positive, Negative, and General Subscales

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.

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.

Posted

Mean

Standard Deviation

units on a scale

Baseline, Week 12

ID	Title	Description
OG000	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).
OG001	PF-02545920 15 mg BID

Secondary

Change From Baseline to Week 12 in PANSS-Derived Marder Factor Scores

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.

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.

Posted

Mean

Standard Deviation

units on a scale

Baseline, Week 12

ID	Title	Description
OG000	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).
OG001	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).

Secondary

Change From Baseline to Week 12 in Clinical Global Impression of Severity (CGI-S)

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.

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.

Posted

Mean

Standard Deviation

units on a scale

Baseline, Week 12

ID	Title	Description
OG000	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).
OG001	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).

Secondary

Clinical Global Impression - Improvement (CGI-I) Total Score 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.

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

Posted

Mean

Standard Deviation

units on a scale

Week 12

ID	Title	Description
OG000	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).
OG001	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).

Secondary

Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations Due to Adverse Events (AEs)

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.

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

Posted

Number

participants

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

ID	Title	Description
OG000	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).
OG001	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).

Secondary

Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria

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.

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.

Posted

Number

participants

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

ID	Title	Description
OG000	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).
OG001	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).

Secondary

Number of Participants With Electrocardiogram (ECG) Values Meeting Categorical Summarization Criteria

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.

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.

Posted

Number

participants

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

ID	Title	Description
OG000	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).
OG001

Secondary

Number of Participants With Weight Change >=7%

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.

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

Posted

Number

participants

Screening up to Day 84

ID	Title	Description
OG000	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).
OG001	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).
OG002	Placebo

Secondary

Number of Participants With New/Intensified Physical Examination Findings From Baseline by Body Site

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

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

Posted

Number

participants

Baseline and Week 12 or Early Termination

ID	Title	Description
OG000	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).
OG001	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).

Secondary

Number of Participants With Laboratory Test 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).

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

Posted

Number

participants

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

ID	Title	Description
OG000	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).
OG001	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).

Secondary

Number of Participants With Extrapyramidal Motor System (EPS) AEs

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

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

Posted

Number

participants

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

ID	Title	Description
OG000	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).
OG001	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).
OG002

Secondary

Change From Baseline in Cholesterol, Triglycerides (TG), Low-Density Lipoprotein (LDL), and High-Density Lipoprotein (HDL) at Weeks 6 and 12

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

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.

Posted

Mean

Standard Deviation

milligram (mg)/deciliter (dL)

Baseline; Weeks 6 and 12

ID	Title	Description
OG000	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).
OG001	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).

Secondary

Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Weeks 6 and 12

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

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.

Posted

Mean

Standard Deviation

percent

Baseline; Weeks 6 and 12

ID	Title	Description
OG000	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).
OG001	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).

Secondary

Change From Baseline in Insulin at Weeks 6 and 12

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

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.

Posted

Mean

Standard Deviation

micro international unit/milliliter

Baseline; Weeks 6 and 12

ID	Title	Description
OG000	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).
OG001	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).

Secondary

Change From Baseline in Prolactin at Weeks 6 and 12

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

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.

Posted

Mean

Standard Deviation

nanogram (ng)/milliliter

Baseline; Weeks 6 and 12

ID	Title	Description
OG000	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).
OG001	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).

Secondary

Change From Baseline to Week 12 on the Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A)

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.

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

Posted

Mean

Standard Deviation

units on a scale

Baseline, Week 12

ID	Title	Description
OG000	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).
OG001	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).

Secondary

Absolute Values of Movement Disorder Burden Score - Dystonia (MDBS-D) Over Active Treatment Period

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.

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

Posted

Mean

Standard Deviation

units on a scale

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

ID	Title	Description
OG000	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).
OG001	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).

Secondary

Overall Number of Participants With Positive Responses to Categories on the Columbia Suicide Severity Rating Scale (C-SSRS)

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").

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

Posted

Number

participants

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

ID	Title	Description
OG000	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).
OG001	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).

Secondary

Concentration of PF-02545920 and Its Metabolite, PF-01001252

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.

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

Posted

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

ID	Title	Description
OG000	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).
OG001	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).

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute myocardial infarction	Cardiac disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 affected78 at risk EG0010 affected82 at risk EG0020 affected80 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected78 at risk EG0010 affected82 at risk EG0021 affected80 at risk
Alcohol poisoning	Injury, poisoning and procedural complications	MedDRA 17.1	Non-systematic Assessment	EG0000 affected78 at risk EG0010 affected82 at risk EG0021 affected80 at risk
Injury	Injury, poisoning and procedural complications	MedDRA 17.1	Non-systematic Assessment	EG0000 affected78 at risk EG0010 affected82 at risk EG0021 affected80 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA 17.1	Non-systematic Assessment	EG0000 affected78 at risk EG0010 affected82 at risk EG0021 affected80 at risk
Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Non-systematic Assessment	EG0000 affected78 at risk EG0010 affected82 at risk EG0021 affected80 at risk
Paranoia	Psychiatric disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 affected78 at risk EG0010 affected82 at risk EG0020 affected80 at risk
Psychotic disorder	Psychiatric disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected78 at risk EG0010 affected82 at risk EG0021 affected80 at risk
Suicide attempt	Psychiatric disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected78 at risk EG0010 affected82 at risk EG0021 affected80 at risk

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Dry mouth	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0004 affected78 at risk EG0014 affected82 at risk EG0023 affected80 at risk
Nausea	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0002 affected78 at risk EG0014 affected82 at risk EG0025 affected80 at risk
Vomiting	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0004 affected78 at risk EG0011 affected82 at risk EG0023 affected80 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0001 affected78 at risk EG0014 affected82 at risk EG0026 affected80 at risk
Headache	Nervous system disorders	MedDRA 17.1	Non-systematic Assessment	EG0005 affected78 at risk EG0011 affected82 at risk EG0026 affected80 at risk
Sedation	Nervous system disorders	MedDRA 17.1	Non-systematic Assessment	EG0004 affected78 at risk EG0016 affected82 at risk EG0027 affected80 at risk
Somnolence	Nervous system disorders	MedDRA 17.1	Non-systematic Assessment	EG0005 affected78 at risk EG0018 affected82 at risk EG0022 affected80 at risk

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders

ID	Term
C545121	2-((4-(1-methyl-4-pyridin-4-yl-1H-pyrazol-3-yl)phenoxy)methyl)quinoline
C494814	BID protein, human

ID	Title	Description
BG000	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).
BG001	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).
BG002	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).
BG003	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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).	2	78	20	78
EG001	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).	0	82	22	82
EG002	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).	6	80	25	80