Trial Outcomes & Findings for Study Evaluating The Safety, Tolerability And Brain Function Of 2 Doses Of PF-0254920 In Subjects With Early Huntington's Disease (NCT NCT01806896)
NCT ID: NCT01806896
Last Updated: 2017-12-14
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
37 participants
Primary outcome timeframe
Baseline up to Day 38
Results posted on
2017-12-14
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
17
|
|
Overall Study
Received Treatment
|
19
|
17
|
|
Overall Study
COMPLETED
|
17
|
17
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
|
Overall Study
Other
|
1
|
0
|
Baseline Characteristics
Study Evaluating The Safety, Tolerability And Brain Function Of 2 Doses Of PF-0254920 In Subjects With Early Huntington's Disease
Baseline characteristics by cohort
| Measure |
PF-02545920 20 mg Twice a Day
n=19 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.
|
Placebo Twice a Day
n=17 Participants
Participants received placebo matched to PF-02545920 orally every 12 hours for 28 days, followed by a 7 to 10 day safety evaluation period.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.4 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
43.1 years
STANDARD_DEVIATION 11.8 • n=7 Participants
|
45.4 years
STANDARD_DEVIATION 12.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 38Population: The safety analysis population included all participants who received at least 1 dose of PF-02545920 or placebo.
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.
Outcome measures
| Measure |
PF-02545920 20 mg Twice a Day
n=19 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.
|
Placebo Twice a Day
n=17 Participants
Participants received placebo matched to PF-02545920 orally every 12 hours for 28 days, followed by a 7 to 10 day safety evaluation period.
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
AEs
|
18 participants
|
14 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
SAEs
|
1 participants
|
1 participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 38Population: The safety analysis population included all participants who received at least 1 dose of PF-02545920 or placebo.
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 \[HbA1c, if diabetic\]).
Outcome measures
| Measure |
PF-02545920 20 mg Twice a Day
n=19 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.
|
Placebo Twice a Day
n=17 Participants
Participants received placebo matched to PF-02545920 orally every 12 hours for 28 days, followed by a 7 to 10 day safety evaluation period.
|
|---|---|---|
|
Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern (Without Regard to Baseline Abnormality)
|
8 participants
|
8 participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 38Population: The safety analysis population included all participants who received at least 1 dose of PF-02545920 or placebo.
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.
Outcome measures
| Measure |
PF-02545920 20 mg Twice a Day
n=19 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.
|
Placebo Twice a Day
n=17 Participants
Participants received placebo matched to PF-02545920 orally every 12 hours for 28 days, followed by a 7 to 10 day safety evaluation period.
|
|---|---|---|
|
Number of Participants With Potentially Clinically Significant Vital Signs Findings
Standing DBP <50 mmHg
|
1 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Vital Signs Findings
Supine Pulse Rate <40 or >120 bpm
|
0 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Vital Signs Findings
Supine SBP <90 mmHg
|
0 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Vital Signs Findings
Standing SBP <90 mmHg
|
1 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Vital Signs Findings
Supine DBP <50 mmHg
|
2 participants
|
1 participants
|
|
Number of Participants With Potentially Clinically Significant Vital Signs Findings
Standing Pulse Rate <40 or >140 bpm
|
1 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Vital Signs Findings
Increase From Baseline in Supine SBP >=30 mmHg
|
1 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Vital Signs Findings
Increase From Baseline in Standing SBP >=30 mmHg
|
2 participants
|
2 participants
|
|
Number of Participants With Potentially Clinically Significant Vital Signs Findings
Increase From Baseline in Supine DBP >=20 mmHg
|
1 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Vital Signs Findings
Increase From Baseline in Standing DBP >=20 mmHg
|
1 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Vital Signs Findings
Decrease From Baseline in Supine SBP >=30 mmHg
|
1 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Vital Signs Findings
Decrease From Baseline in Standing SBP >=30 mmHg
|
1 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Vital Signs Findings
Decrease From Baseline in Supine DBP >=20 mmHg
|
2 participants
|
1 participants
|
|
Number of Participants With Potentially Clinically Significant Vital Signs Findings
Decrease From Baseline in Standing DBP >=20 mmHg
|
3 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 38Population: The safety analysis population included all participants who received at least 1 dose of PF-02545920 or placebo.
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.
Outcome measures
| Measure |
PF-02545920 20 mg Twice a Day
n=19 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.
|
Placebo Twice a Day
n=17 Participants
Participants received placebo matched to PF-02545920 orally every 12 hours for 28 days, followed by a 7 to 10 day safety evaluation period.
|
|---|---|---|
|
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings
PR Interval >=200 msec
|
1 participants
|
1 participants
|
|
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings
PR Interval >=300 msec
|
0 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings
QTcF Interval 450-<480 msec
|
2 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings
QTcF Interval 480-<500 msec
|
0 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings
QTcF Interval >=500 msec
|
0 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings
PR Interval >=25% increase when baseline >100 msec
|
0 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings
PR Interval >=25% increase when baseline >200 msec
|
0 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings
QRS >=50% increase when baseline <=100 msec
|
0 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings
QRS >=50% increase when baseline <=200 msec
|
0 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings
QTcF Interval Increase 30-<60 msec
|
1 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings
QTcF Interval Increase >=60 msec
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 38Population: The safety analysis population included all participants who received at least 1 dose of PF-02545920 or placebo.
Weight assessment was performed by a study physician or a trained study nurse and was included in the physical examination.
Outcome measures
| Measure |
PF-02545920 20 mg Twice a Day
n=19 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.
|
Placebo Twice a Day
n=17 Participants
Participants received placebo matched to PF-02545920 orally every 12 hours for 28 days, followed by a 7 to 10 day safety evaluation period.
|
|---|---|---|
|
Number of Participants With Change From Baseline in Body Weight of >=7%
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 38Population: The safety analysis population included all participants who received at least 1 dose of PF-02545920 or placebo.
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.
Outcome measures
| Measure |
PF-02545920 20 mg Twice a Day
n=19 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.
|
Placebo Twice a Day
n=17 Participants
Participants received placebo matched to PF-02545920 orally every 12 hours for 28 days, followed by a 7 to 10 day safety evaluation period.
|
|---|---|---|
|
Categorical Summary of Participants Meeting Stopping Criteria
WBC 2000-3000 or ANC 1000-1500 cells/mm^3
|
0 participants
|
1 participants
|
|
Categorical Summary of Participants Meeting Stopping Criteria
WBC <2000 or ANC <1000 cells/mm^3
|
0 participants
|
0 participants
|
|
Categorical Summary of Participants Meeting Stopping Criteria
Discontinued/Suspended Due to WBC or ANC Findings
|
0 participants
|
0 participants
|
|
Categorical Summary of Participants Meeting Stopping Criteria
ANC<500 cells/mm^3
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Baseline, Day 28Population: The full analysis population included all participants randomized and had taken at least 1 dose of PF-02545920 or placebo.
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).
Outcome measures
| Measure |
PF-02545920 20 mg Twice a Day
n=19 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.
|
Placebo Twice a Day
n=17 Participants
Participants received placebo matched to PF-02545920 orally every 12 hours for 28 days, followed by a 7 to 10 day safety evaluation period.
|
|---|---|---|
|
Change From Baseline in Unified Huntington Disease Rating Scale (UHDRS) Total Motor Score at Day 28
|
0.19 units on a scale
90% Confidence Interval 6.23 • Interval -1.73 to 2.12
|
0.90 units on a scale
90% Confidence Interval 5.70 • Interval -1.14 to 2.94
|
PRIMARY outcome
Timeframe: Baseline (Day 1)Population: The full analysis population included all participants randomized and had taken at least 1 dose of PF-02545920 or placebo.
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.
Outcome measures
| Measure |
PF-02545920 20 mg Twice a Day
n=19 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.
|
Placebo Twice a Day
n=17 Participants
Participants received placebo matched to PF-02545920 orally every 12 hours for 28 days, followed by a 7 to 10 day safety evaluation period.
|
|---|---|---|
|
Number of Participants With Suicidal Tendencies (C-SSRS Mapped to C-CASA) at Baseline
Completed Suicide
|
0 participants
|
0 participants
|
|
Number of Participants With Suicidal Tendencies (C-SSRS Mapped to C-CASA) at Baseline
Suicide Attempt
|
0 participants
|
0 participants
|
|
Number of Participants With Suicidal Tendencies (C-SSRS Mapped to C-CASA) at Baseline
Acts Towards Imminent Suicidal Behavior
|
0 participants
|
0 participants
|
|
Number of Participants With Suicidal Tendencies (C-SSRS Mapped to C-CASA) at Baseline
Suicidal Ideation
|
1 participants
|
0 participants
|
|
Number of Participants With Suicidal Tendencies (C-SSRS Mapped to C-CASA) at Baseline
Self-Injurious Behavior, No Suicidal Intent
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Day 7Population: The full analysis population included all participants randomized and had taken at least 1 dose of PF-02545920 or placebo.
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.
Outcome measures
| Measure |
PF-02545920 20 mg Twice a Day
n=19 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.
|
Placebo Twice a Day
n=17 Participants
Participants received placebo matched to PF-02545920 orally every 12 hours for 28 days, followed by a 7 to 10 day safety evaluation period.
|
|---|---|---|
|
Number of Participants With Suicidal Tendencies (C-SSRS Mapped to C-CASA) at Day 7
Completed Suicide
|
0 participants
|
0 participants
|
|
Number of Participants With Suicidal Tendencies (C-SSRS Mapped to C-CASA) at Day 7
Suicide Attempt
|
0 participants
|
0 participants
|
|
Number of Participants With Suicidal Tendencies (C-SSRS Mapped to C-CASA) at Day 7
Acts Towards Imminent Suicidal Behavior
|
0 participants
|
0 participants
|
|
Number of Participants With Suicidal Tendencies (C-SSRS Mapped to C-CASA) at Day 7
Suicidal Ideation
|
0 participants
|
0 participants
|
|
Number of Participants With Suicidal Tendencies (C-SSRS Mapped to C-CASA) at Day 7
Self-Injurious Behavior, No Suicidal Intent
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Day 28Population: The full analysis population included all participants randomized and had taken at least 1 dose of PF-02545920 or placebo.
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.
Outcome measures
| Measure |
PF-02545920 20 mg Twice a Day
n=19 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.
|
Placebo Twice a Day
n=17 Participants
Participants received placebo matched to PF-02545920 orally every 12 hours for 28 days, followed by a 7 to 10 day safety evaluation period.
|
|---|---|---|
|
Number of Participants With Suicidal Tendencies (C-SSRS Mapped to C-CASA) at Day 28
Suicide Attempt
|
0 participants
|
0 participants
|
|
Number of Participants With Suicidal Tendencies (C-SSRS Mapped to C-CASA) at Day 28
Acts Towards Imminent Suicidal Behavior
|
0 participants
|
0 participants
|
|
Number of Participants With Suicidal Tendencies (C-SSRS Mapped to C-CASA) at Day 28
Completed Suicide
|
0 participants
|
0 participants
|
|
Number of Participants With Suicidal Tendencies (C-SSRS Mapped to C-CASA) at Day 28
Suicidal Ideation
|
2 participants
|
0 participants
|
|
Number of Participants With Suicidal Tendencies (C-SSRS Mapped to C-CASA) at Day 28
Self-Injurious Behavior, No Suicidal Intent
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 28Population: 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.
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.
Outcome measures
| Measure |
PF-02545920 20 mg Twice a Day
n=10 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.
|
Placebo Twice a Day
n=12 Participants
Participants received placebo matched to PF-02545920 orally every 12 hours for 28 days, followed by a 7 to 10 day safety evaluation period.
|
|---|---|---|
|
Change From Baseline in Functional Magnetic Resonance Imaging (fMRI) in Monetary Incentive Delay (MID) Task at Day 28
Out_win_Rew>Out_win N Right VS
|
0.36 beta contrasts
90% Confidence Interval 2.00 • Interval -0.04 to 0.77
|
0.89 beta contrasts
90% Confidence Interval 1.14 • Interval 0.53 to 1.26
|
|
Change From Baseline in Functional Magnetic Resonance Imaging (fMRI) in Monetary Incentive Delay (MID) Task at Day 28
Cue Rew>Neut Left VS
|
0.01 beta contrasts
90% Confidence Interval 1.15 • Interval -0.43 to 0.45
|
0.11 beta contrasts
90% Confidence Interval 1.13 • Interval -0.29 to 0.5
|
|
Change From Baseline in Functional Magnetic Resonance Imaging (fMRI) in Monetary Incentive Delay (MID) Task at Day 28
Cue Rew>Neut Right VS
|
-0.20 beta contrasts
90% Confidence Interval 1.11 • Interval -0.66 to 0.26
|
-0.05 beta contrasts
90% Confidence Interval 1.32 • Interval -0.47 to 0.37
|
|
Change From Baseline in Functional Magnetic Resonance Imaging (fMRI) in Monetary Incentive Delay (MID) Task at Day 28
Out_win_Rew>Out_win N Left VS
|
0.20 beta contrasts
90% Confidence Interval 2.33 • Interval -0.26 to 0.66
|
0.45 beta contrasts
90% Confidence Interval 1.13 • Interval 0.03 to 0.87
|
SECONDARY outcome
Timeframe: Baseline, Day 28Population: 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.
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).
Outcome measures
| Measure |
PF-02545920 20 mg Twice a Day
n=16 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.
|
Placebo Twice a Day
n=17 Participants
Participants received placebo matched to PF-02545920 orally every 12 hours for 28 days, followed by a 7 to 10 day safety evaluation period.
|
|---|---|---|
|
Change From Baseline in Grip Strength Incentive Motivation Task at Day 28: Percent of Maximum Voluntary Contraction (MVC)
Neutral Emotional Incentive Day 28
|
0.93 percentage of MVC
Interval -3.28 to 5.14
|
-6.37 percentage of MVC
Interval -10.43 to -2.31
|
|
Change From Baseline in Grip Strength Incentive Motivation Task at Day 28: Percent of Maximum Voluntary Contraction (MVC)
Positive Emotional Incentive Day 28
|
1.10 percentage of MVC
Interval -3.1 to 5.31
|
-6.47 percentage of MVC
Interval -10.53 to -2.4
|
|
Change From Baseline in Grip Strength Incentive Motivation Task at Day 28: Percent of Maximum Voluntary Contraction (MVC)
Negative Emotional Incentive Day 28
|
0.18 percentage of MVC
Interval -4.02 to 4.39
|
-7.10 percentage of MVC
Interval -11.16 to -3.04
|
|
Change From Baseline in Grip Strength Incentive Motivation Task at Day 28: Percent of Maximum Voluntary Contraction (MVC)
0.01 Euro Monetary Incentive Day 28
|
-13.47 percentage of MVC
Interval -17.79 to -9.14
|
-14.45 percentage of MVC
Interval -18.59 to -10.31
|
|
Change From Baseline in Grip Strength Incentive Motivation Task at Day 28: Percent of Maximum Voluntary Contraction (MVC)
0.1 Euro Monetary Incentive Day 28
|
-1.19 percentage of MVC
Interval -5.43 to 3.06
|
-5.97 percentage of MVC
Interval -10.04 to -1.89
|
|
Change From Baseline in Grip Strength Incentive Motivation Task at Day 28: Percent of Maximum Voluntary Contraction (MVC)
1 Euro Monetary Incentive Day 28
|
16.85 percentage of MVC
Interval 12.49 to 21.21
|
0.50 percentage of MVC
Interval -3.78 to 4.78
|
Adverse Events
PF-02545920 20 mg Twice a Day
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Placebo Twice a Day
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PF-02545920 20 mg Twice a Day
n=19 participants at risk
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.
|
Placebo Twice a Day
n=17 participants at risk
Participants received placebo matched to PF-02545920 orally every 12 hours for 28 days, followed by a 7 to 10 day safety evaluation period.
|
|---|---|---|
|
Nervous system disorders
Chorea
|
5.3%
1/19 • 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.
|
0.00%
0/17 • 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.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/19 • 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.
|
5.9%
1/17 • 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.
|
Other adverse events
| Measure |
PF-02545920 20 mg Twice a Day
n=19 participants at risk
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.
|
Placebo Twice a Day
n=17 participants at risk
Participants received placebo matched to PF-02545920 orally every 12 hours for 28 days, followed by a 7 to 10 day safety evaluation period.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/19 • 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.
|
5.9%
1/17 • 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.
|
|
Cardiac disorders
Palpitations
|
5.3%
1/19 • 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.
|
0.00%
0/17 • 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.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/19 • 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.
|
11.8%
2/17 • 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.
|
|
Gastrointestinal disorders
Abdominal pain
|
10.5%
2/19 • 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.
|
0.00%
0/17 • 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.
|
|
Gastrointestinal disorders
Constipation
|
5.3%
1/19 • 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.
|
0.00%
0/17 • 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.
|
|
Gastrointestinal disorders
Diarrhoea
|
15.8%
3/19 • 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.
|
11.8%
2/17 • 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.
|
|
Gastrointestinal disorders
Dry mouth
|
21.1%
4/19 • 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.
|
5.9%
1/17 • 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.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/19 • 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.
|
5.9%
1/17 • 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.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
5.3%
1/19 • 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.
|
0.00%
0/17 • 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.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/19 • 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.
|
5.9%
1/17 • 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.
|
|
Gastrointestinal disorders
Nausea
|
26.3%
5/19 • 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.
|
11.8%
2/17 • 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.
|
|
Gastrointestinal disorders
Vomiting
|
10.5%
2/19 • 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.
|
0.00%
0/17 • 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.
|
|
General disorders
Asthenia
|
10.5%
2/19 • 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.
|
5.9%
1/17 • 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.
|
|
General disorders
Fatigue
|
42.1%
8/19 • 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.
|
23.5%
4/17 • 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.
|
|
General disorders
Feeling hot
|
5.3%
1/19 • 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.
|
0.00%
0/17 • 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.
|
|
General disorders
Gait disturbance
|
0.00%
0/19 • 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.
|
5.9%
1/17 • 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.
|
|
General disorders
Thirst
|
5.3%
1/19 • 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.
|
5.9%
1/17 • 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.
|
|
Infections and infestations
Nasopharyngitis
|
5.3%
1/19 • 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.
|
0.00%
0/17 • 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.
|
|
Infections and infestations
Pharyngitis
|
5.3%
1/19 • 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.
|
0.00%
0/17 • 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.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/19 • 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.
|
5.9%
1/17 • 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.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/19 • 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.
|
5.9%
1/17 • 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.
|
|
Investigations
Blood pressure increased
|
5.3%
1/19 • 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.
|
0.00%
0/17 • 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.
|
|
Investigations
Blood urine present
|
5.3%
1/19 • 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.
|
0.00%
0/17 • 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.
|
|
Investigations
Electrocardiogram QRS complex prolonged
|
0.00%
0/19 • 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.
|
5.9%
1/17 • 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.
|
|
Investigations
Electrocardiogram QT prolonged
|
5.3%
1/19 • 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.
|
5.9%
1/17 • 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.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/19 • 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.
|
17.6%
3/17 • 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.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.3%
1/19 • 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.
|
0.00%
0/17 • 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.
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.00%
0/19 • 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.
|
5.9%
1/17 • 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.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.3%
1/19 • 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.
|
0.00%
0/17 • 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.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/19 • 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.
|
5.9%
1/17 • 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.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.3%
1/19 • 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.
|
0.00%
0/17 • 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.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/19 • 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.
|
5.9%
1/17 • 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.
|
|
Nervous system disorders
Akathisia
|
10.5%
2/19 • 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.
|
0.00%
0/17 • 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.
|
|
Nervous system disorders
Chorea
|
21.1%
4/19 • 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.
|
0.00%
0/17 • 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.
|
|
Nervous system disorders
Dysgeusia
|
5.3%
1/19 • 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.
|
0.00%
0/17 • 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.
|
|
Nervous system disorders
Headache
|
26.3%
5/19 • 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.
|
35.3%
6/17 • 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.
|
|
Nervous system disorders
Migraine
|
5.3%
1/19 • 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.
|
5.9%
1/17 • 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.
|
|
Nervous system disorders
Oromandibular dystonia
|
5.3%
1/19 • 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.
|
0.00%
0/17 • 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.
|
|
Nervous system disorders
Presyncope
|
5.3%
1/19 • 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.
|
0.00%
0/17 • 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.
|
|
Nervous system disorders
Somnolence
|
15.8%
3/19 • 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.
|
0.00%
0/17 • 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.
|
|
Psychiatric disorders
Aggression
|
5.3%
1/19 • 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.
|
0.00%
0/17 • 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.
|
|
Psychiatric disorders
Bradyphrenia
|
5.3%
1/19 • 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.
|
0.00%
0/17 • 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.
|
|
Psychiatric disorders
Insomnia
|
10.5%
2/19 • 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.
|
0.00%
0/17 • 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.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/19 • 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.
|
5.9%
1/17 • 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.
|
|
Psychiatric disorders
Libido decreased
|
5.3%
1/19 • 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.
|
0.00%
0/17 • 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.
|
|
Psychiatric disorders
Negative thoughts
|
5.3%
1/19 • 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.
|
0.00%
0/17 • 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.
|
|
Renal and urinary disorders
Pollakiuria
|
5.3%
1/19 • 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.
|
0.00%
0/17 • 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.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/19 • 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.
|
5.9%
1/17 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.3%
1/19 • 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.
|
0.00%
0/17 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.3%
1/19 • 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.
|
0.00%
0/17 • 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.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/19 • 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.
|
5.9%
1/17 • 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.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
21.1%
4/19 • 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.
|
0.00%
0/17 • 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.
|
|
Vascular disorders
Hot flush
|
10.5%
2/19 • 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.
|
0.00%
0/17 • 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.
|
Additional Information
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