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A Study To Assess the Effects Of PF-04457845 On BOLD fMRI In Subjects With Post Traumatic Stress Disorder

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ClinicalTrials.gov Identifier: NCT02216097
Recruitment Status : Terminated (The study stopped based on Pfizer portfolio prioritization and not due to safety and/or efficacy concern or change in benefit:risk assessment of PF-04457845.)
First Posted : August 13, 2014
Results First Posted : April 8, 2016
Last Update Posted : June 29, 2016
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Post-Traumatic Stress Disorder
Interventions Drug: PF-04457845
Drug: Placebo
Enrollment 14
Recruitment Details  
Pre-assignment Details  
Arm/Group Title PF-04457845 Placebo
Hide Arm/Group Description PF-04457845 4 milligrams (mg) was orally administered once daily in the morning on Days 1 to 7. Placebo matched to PF-04457845 was orally administered once daily in the morning on Days 1 to 7.
Period Title: Overall Study
Started 8 6
Completed 8 6
Not Completed 0 0
Arm/Group Title PF-04457845 Placebo Total
Hide Arm/Group Description PF-04457845 4 milligrams (mg) was orally administered once daily in the morning on Days 1 to 7. Placebo matched to PF-04457845 was orally administered once daily in the morning on Days 1 to 7. Total of all reporting groups
Overall Number of Baseline Participants 8 6 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 6 participants 14 participants
35.6  (11.4) 36.2  (15.1) 35.9  (12.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 6 participants 14 participants
Female
5
  62.5%
4
  66.7%
9
  64.3%
Male
3
  37.5%
2
  33.3%
5
  35.7%
1.Primary Outcome
Title Change From Baseline Blood-Oxygen-Level Dependent (BOLD) Functional Magnetic Resonance Imaging fMRI) Percent Signal Change in Fearful Versus Neutral Face Contrast in Bilateral Amygdala
Hide Description Baseline BOLD fMRI percent signal change measured from baseline in fearful versus neutral face contrast during the emotional face processing task in bilateral amygdala.
Time Frame Baseline, Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
There were no efficacy evaluations done in this study because of a change in the planned analysis after the study was prematurely terminated due to Good Clinical Practice (GCP) non-compliance that resulted in data integrity and quality issues.
Arm/Group Title PF-04457845 Placebo
Hide Arm/Group Description:
PF-04457845 4 milligrams (mg) was orally administered once daily in the morning on Days 1 to 7.
Placebo matched to PF-04457845 was orally administered once daily in the morning on Days 1 to 7.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Change From Baseline in BOLD fMRI Percent Activation in Bilateral Ventromedial Pre-Frontal Cortex (vmPFC)
Hide Description Difference measured in BOLD fMRI percent activation in the bilateral vmPFC during the fear extinction recall phase of the fear extinction paradigm.
Time Frame Baseline, Day 2
Hide Outcome Measure Data
Hide Analysis Population Description
There were no efficacy evaluations done in this study because of a change in the planned analysis after the study was prematurely terminated due to GCP non-compliance that resulted in data integrity and quality issues.
Arm/Group Title PF-04457845 Placebo
Hide Arm/Group Description:
PF-04457845 4 milligrams (mg) was orally administered once daily in the morning on Days 1 to 7.
Placebo matched to PF-04457845 was orally administered once daily in the morning on Days 1 to 7.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Change From Baseline in BOLD fMRI Percent Signal Change in Fearful Versus Neutral Face Contrast in Right Amygdala
Hide Description Difference measured in BOLD fMRI percent signal change in the right amygdala in fear versus neutral faces during the emotional face processing task.
Time Frame Baseline, Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
There were no efficacy evaluations done in this study because of a change in the planned analysis after the study was prematurely terminated due to GCP non-compliance that resulted in data integrity and quality issues.
Arm/Group Title PF-04457845 Placebo
Hide Arm/Group Description:
PF-04457845 4 milligrams (mg) was orally administered once daily in the morning on Days 1 to 7.
Placebo matched to PF-04457845 was orally administered once daily in the morning on Days 1 to 7.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Change From Baseline in BOLD fMRI Percent Signal Change in Fearful Versus Neutral Face Contrast in Left Amygdala
Hide Description Difference measured in BOLD fMRI percent signal change in the left amygdala in fearful versus neutral faces during face processing task.
Time Frame Baseline, Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
There were no efficacy evaluations done in this study because of a change in the planned analysis after the study was prematurely terminated due to GCP non-compliance that resulted in data integrity and quality issues.
Arm/Group Title PF-04457845 Placebo
Hide Arm/Group Description:
PF-04457845 4 milligrams (mg) was orally administered once daily in the morning on Days 1 to 7.
Placebo matched to PF-04457845 was orally administered once daily in the morning on Days 1 to 7.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Number of Participants With Abnormal Physical Examination Findings
Hide Description The full physical examination included head, ears, eyes, nose, mouth, skin, heart, and lung examinations, lymph nodes, gastrointestinal, skeletal, and neurological systems.
Time Frame Baseline to up to Day 18
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population included all participants who received study medication.
Arm/Group Title PF-04457845 Placebo
Hide Arm/Group Description:
PF-04457845 4 milligrams (mg) was orally administered once daily in the morning on Days 1 to 7.
Placebo matched to PF-04457845 was orally administered once daily in the morning on Days 1 to 7.
Overall Number of Participants Analyzed 8 6
Measure Type: Number
Unit of Measure: participants
0 0
6.Secondary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Withdrawals Due to AEs
Hide Description An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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 study drug and up to 28 days after last study drug administration that were absent before treatment or that worsened relative to pretreatment state. AEs included non-serious AEs and SAEs.
Time Frame Baseline up to 28 days after last study drug administration (Day 35)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population included all participants who received study medication.
Arm/Group Title PF-04457845 Placebo
Hide Arm/Group Description:
PF-04457845 4 milligrams (mg) was orally administered once daily in the morning on Days 1 to 7.
Placebo matched to PF-04457845 was orally administered once daily in the morning on Days 1 to 7.
Overall Number of Participants Analyzed 8 6
Measure Type: Number
Unit of Measure: participants
Number of Participants with AEs 6 4
Number of Participants with SAEs 0 0
Number of Participants Discontinued Due to AEs 0 0
7.Secondary Outcome
Title Number of Participants With Clinical Laboratory Values Meeting Criteria for Potential Clinical Concern
Hide Description The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell count, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes; liver function (aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, albumin, total protein); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (sodium, potassium, chloride, calcium, bicarbonate); chemistry (glucose); urinalysis (dipstick) (urine pH, urine glucose, urine protein, urine blood, urine ketones, urine bilirubin, urine nitrite, urine leukocyte esterase); urinalysis microscopy (urine red blood cell, urine white blood cell, urine bacteria). Only parameters with abnormal values were reported.
Time Frame Baseline up to Day 18
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population included all participants who received study medication.
Arm/Group Title PF-04457845 Placebo
Hide Arm/Group Description:
PF-04457845 4 milligrams (mg) was orally administered once daily in the morning on Days 1 to 7.
Placebo matched to PF-04457845 was orally administered once daily in the morning on Days 1 to 7.
Overall Number of Participants Analyzed 8 6
Measure Type: Number
Unit of Measure: participants
Total neutrophils <0.8 times lower limit of normal 1 0
Urine positive for nitrite 1 0
Urine positive for leukocyte esterase 0 1
8.Secondary Outcome
Title Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern
Hide Description Vital signs assessment included pulse rate and blood pressure. Criteria for vital sign values meeting potential clinical concern included: supine pulse rate <40 or >120 beats per minute (bpm), standing pulse rate <40 or >140 bpm; systolic blood pressure (SBP) of >=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.
Time Frame Baseline up to Day 18
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population included all participants who received study medication.
Arm/Group Title PF-04457845 Placebo
Hide Arm/Group Description:
PF-04457845 4 milligrams (mg) was orally administered once daily in the morning on Days 1 to 7.
Placebo matched to PF-04457845 was orally administered once daily in the morning on Days 1 to 7.
Overall Number of Participants Analyzed 8 6
Measure Type: Number
Unit of Measure: participants
Supine SBP <90 mmHg 0 0
Standing SBP <90 mmHg 0 0
Supine DBP <50 mmHg 0 0
Standing DBP <50 mmHg 0 0
Supine Pulse Rate <40 or >120 bpm 0 0
Standing Pulse Rate <40 or >140 bpm 0 0
Supine SBP >=30 mmHg Increase From Baseline 0 0
Standing SBP >=30 mmHg Increase From Baseline 0 1
Supine DBP >=20 mmHg Increase From Baseline 1 0
Standing DBP >=20 mmHg Increase From Baseline 0 0
Supine SBP >=30 mmHg Decrease From Baseline 0 0
Standing SBP >=30 mmHg Decrease From Baseline 0 0
Supine DBP >=20 mmHg Decrease From Baseline 0 0
Standing DBP >=20 mmHg Decrease From Baseline 1 1
9.Secondary Outcome
Title Number of Participants With Post-Baseline Electrocardiogram (ECG) Values Meeting Criteria of Potential Clinical Concern
Hide Description ECG criteria of potential clinical concern were QTc absolute value >=450 milliseconds (msec) or QTc absolute change >=30 msec.
Time Frame Baseline up to Day 18
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population included all participants who received study medication.
Arm/Group Title PF-04457845 Placebo
Hide Arm/Group Description:
PF-04457845 4 milligrams (mg) was orally administered once daily in the morning on Days 1 to 7.
Placebo matched to PF-04457845 was orally administered once daily in the morning on Days 1 to 7.
Overall Number of Participants Analyzed 8 6
Measure Type: Number
Unit of Measure: participants
QTcF Interval 450-<480 msec 0 0
QTcF Interval 480-<500 msec 0 0
QTcF Interval >=500 msec 0 0
QTcF Interval >=30 msec Increase From Baseline 0 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PF-04457845 Placebo
Hide Arm/Group Description PF-04457845 4 milligrams (mg) was orally administered once daily in the morning on Days 1 to 7. Placebo matched to PF-04457845 was orally administered once daily in the morning on Days 1 to 7.
All-Cause Mortality
PF-04457845 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
PF-04457845 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/0      0/0    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
PF-04457845 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/8 (75.00%)      4/6 (66.67%)    
Cardiac disorders     
Palpitations * 1  1/8 (12.50%)  1 0/6 (0.00%)  0
Gastrointestinal disorders     
Abdominal discomfort * 1  1/8 (12.50%)  1 0/6 (0.00%)  0
Diarrhoea * 1  1/8 (12.50%)  2 0/6 (0.00%)  0
Nausea * 1  1/8 (12.50%)  1 1/6 (16.67%)  1
General disorders     
Chest discomfort * 1  0/8 (0.00%)  0 1/6 (16.67%)  1
Fatigue * 1  0/8 (0.00%)  0 1/6 (16.67%)  1
Infections and infestations     
Nasopharyngitis * 1  1/8 (12.50%)  1 0/6 (0.00%)  0
Injury, poisoning and procedural complications     
Post procedural haematoma * 1  0/8 (0.00%)  0 1/6 (16.67%)  1
Metabolism and nutrition disorders     
Decreased appetite * 1  1/8 (12.50%)  1 0/6 (0.00%)  0
Nervous system disorders     
Dizziness * 1  2/8 (25.00%)  3 0/6 (0.00%)  0
Headache * 1  4/8 (50.00%)  4 3/6 (50.00%)  3
Migraine * 1  0/8 (0.00%)  0 1/6 (16.67%)  1
Sleep paralysis * 1  0/8 (0.00%)  0 1/6 (16.67%)  1
Psychiatric disorders     
Affect lability * 1  1/8 (12.50%)  1 0/6 (0.00%)  0
Flashback * 1  1/8 (12.50%)  1 0/6 (0.00%)  0
Post-traumatic stress disorder * 1  1/8 (12.50%)  1 0/6 (0.00%)  0
Skin and subcutaneous tissue disorders     
Pruritus * 1  1/8 (12.50%)  1 0/6 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 18.1
There were no efficacy evaluations done in this study because of a change in the planned analysis after the study was prematurely terminated due to GCP non-compliance that resulted in data integrity and quality issues.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Restriction Description: Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02216097    
Other Study ID Numbers: B0541013
First Submitted: August 12, 2014
First Posted: August 13, 2014
Results First Submitted: March 10, 2016
Results First Posted: April 8, 2016
Last Update Posted: June 29, 2016