Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2012-004432-31 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will evaluate the Safety, Tolerability and Brain Function of 2 doses of PF-0254920 in Subjects with Early Huntington's Disease.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 20 mg Arm Cohort A | Experimental |
| |
| Placebo Arm Cohort A | Placebo Comparator |
| |
| 5 mg Arm Cohort B | Experimental |
| |
| Placebo Arm Cohort B | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-02545920 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. 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 are events between first dose of treatment and up to the follow-up period that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-serious AEs. | Baseline up to Day 38 |
| Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern (Without Regard to Baseline Abnormality) | The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell [RBC] count, platelet count, white blood cell [WBC] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen [BUN], creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase [AST], alanine aminotransferase [ALT], total and direct bilirubin, alkaline phosphatase, uric acid, albumin, and total protein; urinalysis (pH, glucose, protein/albumin, hemoglobin/blood, ketones/acetone, nitrites, leukocyte esterase, microscopy [if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase]); others (urine/serum pregnancy test, glycosylated hemoglobin [HbA1c, if diabetic]). | Baseline up to Day 38 |
| Number of Participants With Potentially Clinically Significant Vital Signs Findings | Vital signs assessment included pulse rate and blood pressure. Criteria for vital sign values meeting potential clinical concern included: supine/sitting pulse rate less than (<)40 or greater than (>)120 beats per minute (bpm), standing pulse rate <40 or >140 bpm; systolic blood pressure (SBP) of greater than or equal to (>=)30 millimeters of mercury (mmHg) change from baseline or SBP <90 mmHg, diastolic blood pressure (DBP) >=20 mmHg change from baseline or DBP <50 mmHg. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Functional Magnetic Resonance Imaging (fMRI) in Monetary Incentive Delay (MID) Task at Day 28 | The monetary incentive delay (MID) task is established as a reliable method to elicit ventral striatal (VS) activity in relation to reward/punishment anticipation and tracked with dysfunctionalities across a range of conditions in which incentive motivation is thought to be abnormal (schizophrenia, depression, substance abuse, and pathological gambling). Pharmacological intervention has demonstrated reversal of observed deficit. The beta contrast value of 'REW' is for analysis of reward-related activity in VS within the task-related 'reward network' during the gain condition (relative to neutral) of the MID task. The changes in beta contrasts (fMRI) provided are changes in parameter estimates and do not have a unit of measure. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre d'Investigation Clinique (CIC)/ Institut du Cerveau et de la Möelle Epinière (ICM) | Paris | 75651 | France |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | PF-02545920 20 mg Twice a Day | Participants received PF-02545920 orally every 12 hours according to a titration dosing scheme: 5 mg twice daily (BID) on Days 1-2, 10 mg BID on Days 3-4, 15 mg BID on Days 5-6, and 20 mg BID on Days 7-28; followed by a 7 to 10 day safety evaluation period. |
| FG001 | Placebo Twice a Day | Participants received placebo matched to PF-02545920 orally every 12 hours for 28 days, followed by a 7 to 10 day safety evaluation period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The baseline analysis population included all participants who were randomized and received at least 1 dose of PF-02545920 or placebo.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | PF-02545920 20 mg Twice a Day | Participants received PF-02545920 orally every 12 hours according to a titration dosing scheme: 5 mg twice daily (BID) on Days 1-2, 10 mg BID on Days 3-4, 15 mg BID on Days 5-6, and 20 mg BID on Days 7-28; followed by a 7 to 10 day safety evaluation period. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. 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 are events between first dose of treatment and up to the follow-up period that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-serious AEs. | The safety analysis population included all participants who received at least 1 dose of PF-02545920 or placebo. | Posted | Number | participants | Baseline up to Day 38 |
|
Baseline up to Day 38
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 non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PF-02545920 20 mg Twice a Day | Participants received PF-02545920 orally every 12 hours according to a titration dosing scheme: 5 mg twice daily (BID) on Days 1-2, 10 mg BID on Days 3-4, 15 mg BID on Days 5-6, and 20 mg BID on Days 7-28; followed by a 7 to 10 day safety evaluation period. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chorea | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 18.0 | Non-systematic Assessment |
The study was initially designed to include 20 mg BID and 5 mg BID. Interim analysis of 20 mg BID/placebo supported the development of PF-02545920, and therefore, 5 mg BID was not enrolled.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Not provided
| ID | Term |
|---|---|
| D006816 | Huntington Disease |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C545121 | 2-((4-(1-methyl-4-pyridin-4-yl-1H-pyrazol-3-yl)phenoxy)methyl)quinoline |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo | Drug | - Orally, approx. Q12H (range 10-14 hours), administered at least one hour prior to, or two hours after meals. Dosing for 28 days. |
|
| PF-02545920 | Drug |
|
|
| Placebo | Drug |
|
|
| Baseline up to Day 38 |
| Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | ECG parameters included PR interval, QRS complex, and corrected QT interval using Fridericia's formula (QTcF). Criteria for ECG changes meeting potential clinical concern included: PR interval ≥200 milliseconds (msec) or ≥25% increase when baseline is >100 msec; QRS interval ≥50% increase from baseline when baseline is less than or equal to (<=)200 msec; and QTcF ≥450 msec or ≥30 msec increase from baseline. | Baseline up to Day 38 |
| Number of Participants With Change From Baseline in Body Weight of >=7% | Weight assessment was performed by a study physician or a trained study nurse and was included in the physical examination. | Baseline up to Day 38 |
| Categorical Summary of Participants Meeting Stopping Criteria | Absolute neutrophil count (ANC) and WBC were monitored for safety. Participants with WBC <3000 but >=2000 cells/mm^3 or ANC <1500 but >=1000 cells/mm^3 were to have study treatment suspended. Participants with WBC <2000 or ANC <1000 cells/mm^3 were to be discontinued from study participation. | Baseline up to Day 38 |
| Change From Baseline in Unified Huntington Disease Rating Scale (UHDRS) Total Motor Score at Day 28 | The UHDRS is a clinical rating scale to provide a uniform assessment of the clinical features and course of Huntington Disease. The Total Motor Score (TMS) is 1 of the 6 components of UHDRS, includes 31 items, and ranges from a scale of 0 to 124 (higher scores indicate more severe disease). | Baseline, Day 28 |
| Number of Participants With Suicidal Tendencies (C-SSRS Mapped to C-CASA) at Baseline | C-SSRS is a participant rated questionnaire to assess suicidal ideation, suicidal behavior, actual attempts (yes or no responses), and intensity of ideation (rated 1=low severity to 5=high severity). Yes/No responses are mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) categories: completed suicide, suicide attempt, preparatory acts towards imminent suicidal behavior, suicidal ideation, and self-injurious behavior, or no suicidal intent. A participant could have a yes or no response in more than 1 category. | Baseline (Day 1) |
| Number of Participants With Suicidal Tendencies (C-SSRS Mapped to C-CASA) at Day 7 | C-SSRS is a participant rated questionnaire to assess suicidal ideation, suicidal behavior, actual attempts (yes or no responses), and intensity of ideation (rated 1=low severity to 5=high severity). Yes/No responses are mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) categories: completed suicide, suicide attempt, preparatory acts toward imminent suicidal behavior, suicidal ideation, and self-injurious behavior, or no suicidal intent. A participant could have a yes or no response in more than 1 category. | Day 7 |
| Number of Participants With Suicidal Tendencies (C-SSRS Mapped to C-CASA) at Day 28 | C-SSRS is a participant rated questionnaire to assess suicidal ideation, suicidal behavior, actual attempts (yes or no responses), and intensity of ideation (rated 1=low severity to 5=high severity). Yes/No responses are mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) categories: completed suicide, suicide attempt, preparatory acts toward imminent suicidal behavior, suicidal ideation, and self-injurious behavior, or no suicidal intent. A participant could have a yes or no response in more than 1 category. | Day 28 |
| Baseline (Day 1), Day 28 |
| Change From Baseline in Grip Strength Incentive Motivation Task at Day 28: Percent of Maximum Voluntary Contraction (MVC) | This incentive force task was developed to independently dissociate the degree to which a participant responds to reward motivation versus emotional motivation. The task itself included 12 repetitions of 9 trial types, for a total of 108 trials, grouped in a single session lasting about 20 minutes. The trial types were generated according to a combination of 3 emotional categories (negative, neutral, and positive pictures presented) and to 3 monetary incentives (0.01, 0.1, and 1€). Emotional categories and monetary incentives were randomly distributed over the trials and the sequence was fixed such that all subjects were assessed on the exact same task. For each trial, the subject was first presented with an emotional picture displayed on screen for 3000 milliseconds (ms). | Baseline, Day 28 |
| Placebo Twice a Day |
Participants received placebo matched to PF-02545920 orally every 12 hours for 28 days, followed by a 7 to 10 day safety evaluation period. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Participants received PF-02545920 orally every 12 hours according to a titration dosing scheme: 5 mg twice daily (BID) on Days 1-2, 10 mg BID on Days 3-4, 15 mg BID on Days 5-6, and 20 mg BID on Days 7-28; followed by a 7 to 10 day safety evaluation period.
| OG001 | Placebo Twice a Day | Participants received placebo matched to PF-02545920 orally every 12 hours for 28 days, followed by a 7 to 10 day safety evaluation period. |
|
|
| Primary | Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern (Without Regard to Baseline Abnormality) | The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell [RBC] count, platelet count, white blood cell [WBC] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen [BUN], creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase [AST], alanine aminotransferase [ALT], total and direct bilirubin, alkaline phosphatase, uric acid, albumin, and total protein; urinalysis (pH, glucose, protein/albumin, hemoglobin/blood, ketones/acetone, nitrites, leukocyte esterase, microscopy [if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase]); others (urine/serum pregnancy test, glycosylated hemoglobin [HbA1c, if diabetic]). | The safety analysis population included all participants who received at least 1 dose of PF-02545920 or placebo. | Posted | Number | participants | Baseline up to Day 38 |
|
|
|
| Primary | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Vital signs assessment included pulse rate and blood pressure. Criteria for vital sign values meeting potential clinical concern included: supine/sitting pulse rate less than (<)40 or greater than (>)120 beats per minute (bpm), standing pulse rate <40 or >140 bpm; systolic blood pressure (SBP) of greater than or equal to (>=)30 millimeters of mercury (mmHg) change from baseline or SBP <90 mmHg, diastolic blood pressure (DBP) >=20 mmHg change from baseline or DBP <50 mmHg. | The safety analysis population included all participants who received at least 1 dose of PF-02545920 or placebo. | Posted | Number | participants | Baseline up to Day 38 |
|
|
|
| Primary | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | ECG parameters included PR interval, QRS complex, and corrected QT interval using Fridericia's formula (QTcF). Criteria for ECG changes meeting potential clinical concern included: PR interval ≥200 milliseconds (msec) or ≥25% increase when baseline is >100 msec; QRS interval ≥50% increase from baseline when baseline is less than or equal to (<=)200 msec; and QTcF ≥450 msec or ≥30 msec increase from baseline. | The safety analysis population included all participants who received at least 1 dose of PF-02545920 or placebo. | Posted | Number | participants | Baseline up to Day 38 |
|
|
|
| Primary | Number of Participants With Change From Baseline in Body Weight of >=7% | Weight assessment was performed by a study physician or a trained study nurse and was included in the physical examination. | The safety analysis population included all participants who received at least 1 dose of PF-02545920 or placebo. | Posted | Number | participants | Baseline up to Day 38 |
|
|
|
| Primary | Categorical Summary of Participants Meeting Stopping Criteria | Absolute neutrophil count (ANC) and WBC were monitored for safety. Participants with WBC <3000 but >=2000 cells/mm^3 or ANC <1500 but >=1000 cells/mm^3 were to have study treatment suspended. Participants with WBC <2000 or ANC <1000 cells/mm^3 were to be discontinued from study participation. | The safety analysis population included all participants who received at least 1 dose of PF-02545920 or placebo. | Posted | Number | participants | Baseline up to Day 38 |
|
|
|
| Primary | Change From Baseline in Unified Huntington Disease Rating Scale (UHDRS) Total Motor Score at Day 28 | The UHDRS is a clinical rating scale to provide a uniform assessment of the clinical features and course of Huntington Disease. The Total Motor Score (TMS) is 1 of the 6 components of UHDRS, includes 31 items, and ranges from a scale of 0 to 124 (higher scores indicate more severe disease). | The full analysis population included all participants randomized and had taken at least 1 dose of PF-02545920 or placebo. | Posted | Least Squares Mean | 90% Confidence Interval | units on a scale | Baseline, Day 28 |
|
|
|
|
| Primary | Number of Participants With Suicidal Tendencies (C-SSRS Mapped to C-CASA) at Baseline | C-SSRS is a participant rated questionnaire to assess suicidal ideation, suicidal behavior, actual attempts (yes or no responses), and intensity of ideation (rated 1=low severity to 5=high severity). Yes/No responses are mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) categories: completed suicide, suicide attempt, preparatory acts towards imminent suicidal behavior, suicidal ideation, and self-injurious behavior, or no suicidal intent. A participant could have a yes or no response in more than 1 category. | The full analysis population included all participants randomized and had taken at least 1 dose of PF-02545920 or placebo. | Posted | Number | participants | Baseline (Day 1) |
|
|
|
| Secondary | Change From Baseline in Functional Magnetic Resonance Imaging (fMRI) in Monetary Incentive Delay (MID) Task at Day 28 | The monetary incentive delay (MID) task is established as a reliable method to elicit ventral striatal (VS) activity in relation to reward/punishment anticipation and tracked with dysfunctionalities across a range of conditions in which incentive motivation is thought to be abnormal (schizophrenia, depression, substance abuse, and pathological gambling). Pharmacological intervention has demonstrated reversal of observed deficit. The beta contrast value of 'REW' is for analysis of reward-related activity in VS within the task-related 'reward network' during the gain condition (relative to neutral) of the MID task. The changes in beta contrasts (fMRI) provided are changes in parameter estimates and do not have a unit of measure. | The analysis population included all participants randomized, who had taken at least 1 dose of PF-02545920 or placebo and who had valid data (thresholded by acceptable motion). n=number of participants analyzed in the respective arms. The per-protocol set (PPS) table was used, not the full analysis set (FAS) table. | Posted | Least Squares Mean | 90% Confidence Interval | beta contrasts | Baseline (Day 1), Day 28 |
|
|
|
|
| Primary | Number of Participants With Suicidal Tendencies (C-SSRS Mapped to C-CASA) at Day 7 | C-SSRS is a participant rated questionnaire to assess suicidal ideation, suicidal behavior, actual attempts (yes or no responses), and intensity of ideation (rated 1=low severity to 5=high severity). Yes/No responses are mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) categories: completed suicide, suicide attempt, preparatory acts toward imminent suicidal behavior, suicidal ideation, and self-injurious behavior, or no suicidal intent. A participant could have a yes or no response in more than 1 category. | The full analysis population included all participants randomized and had taken at least 1 dose of PF-02545920 or placebo. | Posted | Number | participants | Day 7 |
|
|
|
| Primary | Number of Participants With Suicidal Tendencies (C-SSRS Mapped to C-CASA) at Day 28 | C-SSRS is a participant rated questionnaire to assess suicidal ideation, suicidal behavior, actual attempts (yes or no responses), and intensity of ideation (rated 1=low severity to 5=high severity). Yes/No responses are mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) categories: completed suicide, suicide attempt, preparatory acts toward imminent suicidal behavior, suicidal ideation, and self-injurious behavior, or no suicidal intent. A participant could have a yes or no response in more than 1 category. | The full analysis population included all participants randomized and had taken at least 1 dose of PF-02545920 or placebo. | Posted | Number | participants | Day 28 |
|
|
|
| Secondary | Change From Baseline in Grip Strength Incentive Motivation Task at Day 28: Percent of Maximum Voluntary Contraction (MVC) | This incentive force task was developed to independently dissociate the degree to which a participant responds to reward motivation versus emotional motivation. The task itself included 12 repetitions of 9 trial types, for a total of 108 trials, grouped in a single session lasting about 20 minutes. The trial types were generated according to a combination of 3 emotional categories (negative, neutral, and positive pictures presented) and to 3 monetary incentives (0.01, 0.1, and 1€). Emotional categories and monetary incentives were randomly distributed over the trials and the sequence was fixed such that all subjects were assessed on the exact same task. For each trial, the subject was first presented with an emotional picture displayed on screen for 3000 milliseconds (ms). | The analysis population included all participants randomized, who had taken at least 1 dose of PF-02545920 or placebo and who had valid data (acceptable task engagement). n=number of participants analyzed in the respective arms. The PPS table was used, not the FAS table. | Posted | Least Squares Mean | 90% Confidence Interval | percentage of MVC | Baseline, Day 28 |
|
|
|
|
| 1 |
| 19 |
| 18 |
| 19 |
| EG001 | Placebo Twice a Day | Participants received placebo matched to PF-02545920 orally every 12 hours for 28 days, followed by a 7 to 10 day safety evaluation period. | 1 | 17 | 14 | 17 |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Feeling hot | General disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Gait disturbance | General disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Thirst | General disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA 18.0 | Non-systematic Assessment |
|
| Blood urine present | Investigations | MedDRA 18.0 | Non-systematic Assessment |
|
| Electrocardiogram QRS complex prolonged | Investigations | MedDRA 18.0 | Non-systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA 18.0 | Non-systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 18.0 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Glucose tolerance impaired | Metabolism and nutrition disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Akathisia | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Chorea | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Oromandibular dystonia | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Aggression | Psychiatric disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Bradyphrenia | Psychiatric disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Irritability | Psychiatric disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Libido decreased | Psychiatric disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Negative thoughts | Psychiatric disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 18.0 | Non-systematic Assessment |
|
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.
| D003704 | Dementia |
| D002819 | Chorea |
| D020820 | Dyskinesias |
| D009069 | Movement Disorders |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| Supine DBP <50 mmHg |
|
| Standing DBP <50 mmHg |
|
| Supine Pulse Rate <40 or >120 bpm |
|
| Standing Pulse Rate <40 or >140 bpm |
|
| Increase From Baseline in Supine SBP >=30 mmHg |
|
| Increase From Baseline in Standing SBP >=30 mmHg |
|
| Increase From Baseline in Supine DBP >=20 mmHg |
|
| Increase From Baseline in Standing DBP >=20 mmHg |
|
| Decrease From Baseline in Supine SBP >=30 mmHg |
|
| Decrease From Baseline in Standing SBP >=30 mmHg |
|
| Decrease From Baseline in Supine DBP >=20 mmHg |
|
| Decrease From Baseline in Standing DBP >=20 mmHg |
|
| QTcF Interval 450-<480 msec |
|
| QTcF Interval 480-<500 msec |
|
| QTcF Interval >=500 msec |
|
| PR Interval >=25% increase when baseline >100 msec |
|
| PR Interval >=25% increase when baseline >200 msec |
|
| QRS >=50% increase when baseline <=100 msec |
|
| QRS >=50% increase when baseline <=200 msec |
|
| QTcF Interval Increase 30-<60 msec |
|
| QTcF Interval Increase >=60 msec |
|
| Discontinued/Suspended Due to WBC or ANC Findings |
|
| ANC<500 cells/mm^3 |
|
| Acts Towards Imminent Suicidal Behavior |
|
| Suicidal Ideation |
|
| Self-Injurious Behavior, No Suicidal Intent |
|
| Out_win_Rew>Out_win N Left VS |
|
| Out_win_Rew>Out_win N Right VS |
|
|
PF-02545920 versus Placebo (Cue Rew>Neut Right VS) |
| ANCOVA |
Treatment differences are based on a mixed effect model including treatment as fixed effect and baseline, age, gender and CAG repeats as covariates. |
| 0.70 |
2-sided p-value |
| Least square mean |
| -0.15 |
| Standard Error of the Mean |
| 0.37 |
| 2-Sided |
| 90 |
| -0.80 |
| 0.51 |
| Superiority or Other |
| PF-02545920 versus Placebo (Out_win_Rew>Out_win N Left VS) | ANCOVA | Treatment differences are based on a mixed effect model including treatment as fixed effect and baseline, age, gender and CAG repeats as covariates. | 0.51 | 2-sided p-value | Least square mean | -0.25 | Standard Error of the Mean | 0.37 | 2-Sided | 90 | -0.89 | 0.40 | Superiority or Other |
| PF-02545920 versus Placebo (Out_win_Rew>Out_win N Right VS) | ANCOVA | Treatment differences are based on a mixed effect model including treatment as fixed effect and baseline, age, gender and CAG repeats as covariates. | 0.13 | 2-sided p-value | Least square mean | -0.53 | Standard Error of the Mean | 0.33 | 2-Sided | 90 | -1.10 | 0.04 | Superiority or Other |
| Acts Towards Imminent Suicidal Behavior |
|
| Suicidal Ideation |
|
| Self-Injurious Behavior, No Suicidal Intent |
|
| Acts Towards Imminent Suicidal Behavior |
|
| Suicidal Ideation |
|
| Self-Injurious Behavior, No Suicidal Intent |
|
| Negative Emotional Incentive Day 28 |
|
| 0.01 Euro Monetary Incentive Day 28 |
|
| 0.1 Euro Monetary Incentive Day 28 |
|
| 1 Euro Monetary Incentive Day 28 |
|
|
PF-02545920 versus Placebo (Emotional Incentive-Positive) Day 28 |
| ANCOVA |
Mixed effect model including treatment, incentive and treatment*incentive as fixed effects; baseline, age, gender and CAG repeats as covariates. |
| 0.03 |
2-sided p-value |
| Least square mean |
| 7.57 |
| Standard Error of the Mean |
| 3.57 |
| 2-Sided |
| 90 |
| 1.69 |
| 13.45 |
| Superiority or Other |
| PF-02545920 versus Placebo (Emotional Incentive-Negative) Day 28 | ANCOVA | Mixed effect model including treatment, incentive and treatment*incentive as fixed effects; baseline, age, gender and CAG repeats as covariates. | 0.04 | 2-sided p-value | Least square mean | 7.28 | Standard Error of the Mean | 3.56 | 2-Sided | 90 | 1.41 | 13.15 | Superiority or Other |
| PF-02545920 versus Placebo (Monetary Incentive-0.01 Euro) Day 28 | ANCOVA | Mixed effect model including treatment, incentive and treatment*incentive as fixed effects; baseline, age, gender and CAG repeats as covariates. | 0.78 | 2-sided p-value | Least square mean | 0.98 | Standard Error of the Mean | 3.58 | 2-Sided | 90 | -4.91 | 6.87 | Superiority or Other |
| PF-02545920 versus Placebo (Monetary Incentive-0.1 Euro) Day 28 | ANCOVA | Mixed effect model including treatment, incentive and treatment*incentive as fixed effects; baseline, age, gender and CAG repeats as covariates. | 0.18 | 2-sided p-value | Least square mean | 4.78 | Standard Error of the Mean | 3.58 | 2-Sided | 90 | -1.11 | 10.67 | Superiority or Other |
| PF-02545920 versus Placebo (Monetary Incentive-1 Euro) Day 28 | ANCOVA | Mixed effect model including treatment, incentive and treatment*incentive as fixed effects; baseline, age, gender and CAG repeats as covariates. | <0.01 | 2-sided p-value | Least square mean | 16.35 | Standard Error of the Mean | 3.58 | 2-Sided | 90 | 10.46 | 22.24 | Superiority or Other |