Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 10 of 12 for:    "Photosensitive Epilepsy"

PF-06372865 in Subjects With Photosensitive Epilepsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02564029
Recruitment Status : Completed
First Posted : September 30, 2015
Results First Posted : March 14, 2018
Last Update Posted : March 14, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Basic Science
Condition Reflex Epilepsy, Photosensitive
Interventions Drug: PF-06372865
Drug: Placebo
Drug: Lorazepam
Enrollment 7
Recruitment Details  
Pre-assignment Details  
Arm/Group Title All Study Participants
Hide Arm/Group Description Subjects were randomly allocated to one of 4 different treatment sequences that each included the 4 treatment groups: Placebo, PF-06372865 17.5 mg, PF-06372865 52.5 mg and Lorazepam 2 mg.
Period Title: Overall Study
Started 7
Completed 7
Not Completed 0
Arm/Group Title All Participants
Hide Arm/Group Description A total of 7 participants were enrolled and assigned to study treatment.
Overall Number of Baseline Participants 7
Hide Baseline Analysis Population Description
Full analysis set: all participants randomized and who had received at least 1 dose of randomized treatment and had at least 1 primary efficacy measurement in at least 1 study treatment period.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants
27  (7.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
Female
5
  71.4%
Male
2
  28.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
American Indian or Alaska Native 0
Asian 0
Native Hawaiian or Other Pacific Islander 0
Black or African American 0
White 7
More than one race 0
Unknown or Not Reported 0
1.Primary Outcome
Title The Standardized Photosensitivity Range (SPR) in the Subject’s Most Sensitive Eye Condition
Hide Description The SPR was defined as the number of frequency steps between and including the lower and upper bound at which a generalized electroencephalogram (EEG) epileptiform activity had occurred, whereby subjects were exposed to 14 different frequencies ranging from 2 to 60 flashes per second. The SPR is then an integer score that ranges from 0 to 14 with lower scores representing better outcomes. The primary outcome measure was based on the average Least Squares Mean (LSmean) effect over the first 6 hours postdose.
Time Frame Pre-dose, 1, 2, 4 and 6 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set: all participants randomized and who had received at least 1 dose of randomized treatment and had at least 1 primary efficacy measurement in at least 1 study treatment period.
Arm/Group Title PF-06372865 17.5 mg PF-06372865 52.5 mg Lorazepam 2 mg Placebo
Hide Arm/Group Description:
One (1) lorazepam placebo tablet and seven (7) PF-06372865 2.5 mg tablets.
One (1) lorazepam placebo tablet and seven (7) PF-06372865 7.5 mg tablets.
One (1) lorazepam 2 mg tablet and seven (7) PF-06372865 placebo tablets.
One (1) lorazepam placebo tablet and seven (7) PF-06372865 placebo tablets.
Overall Number of Participants Analyzed 7 7 7 7
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
0.57  (0.98) 1.38  (0.96) 1.58  (0.97) 6.80  (0.96)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-06372865 17.5 mg, Placebo
Comments A mixed effects model was applied with fixed effects for period, time, treatment, and the interaction between treatment and time. Baseline was included as 2 separate covariates. The interaction between each baseline covariate and time were included as fixed effects. Participant was fitted as a random effect and time was fitted as a repeated effect within each participant × period. An unstructured correlation matrix was used. The effect reported is an average across all post-dose measurements.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Model Repeated Measures Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -6.23
Confidence Interval (2-Sided) 90%
-8.60 to -3.86
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.37
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PF-06372865 52.5 mg, Placebo
Comments A mixed effects model was applied with fixed effects for period, time, treatment, and the interaction between treatment and time. Baseline was included as 2 separate covariates. The interaction between each baseline covariate and time were included as fixed effects. Participant was fitted as a random effect and time was fitted as a repeated effect within each participant × period. An unstructured correlation matrix was used. The effect reported is an average across all post-dose measurements.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Model Repeated Measures Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -5.42
Confidence Interval (2-Sided) 90%
-7.78 to -3.06
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.36
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Lorazepam 2 mg, Placebo
Comments A mixed effects model was applied with fixed effects for period, time, treatment, and the interaction between treatment and time. Baseline was included as 2 separate covariates. The interaction between each baseline covariate and time were included as fixed effects. Participant was fitted as a random effect and time was fitted as a repeated effect within each participant × period. An unstructured correlation matrix was used. The effect reported is an average across all post-dose measurements.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Model Repeated Measures Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -5.22
Confidence Interval (2-Sided) 90%
-7.60 to -2.84
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.37
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PF-06372865 17.5 mg, PF-06372865 52.5 mg
Comments A mixed effects model was applied with fixed effects for period, time, treatment, and the interaction between treatment and time. Baseline was included as 2 separate covariates. The interaction between each baseline covariate and time were included as fixed effects. Participant was fitted as a random effect and time was fitted as a repeated effect within each participant × period. An unstructured correlation matrix was used. The effect reported is an average across all post-dose measurements.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Model Repeated Measures Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.81
Confidence Interval (2-Sided) 90%
-1.58 to 3.20
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.38
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection PF-06372865 17.5 mg, Lorazepam 2 mg
Comments A mixed effects model was applied with fixed effects for period, time, treatment, and the interaction between treatment and time. Baseline was included as 2 separate covariates. The interaction between each baseline covariate and time were included as fixed effects. Participant was fitted as a random effect and time was fitted as a repeated effect within each participant × period. An unstructured correlation matrix was used. The effect reported is an average across all post-dose measurements.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Model Repreated Measure Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.01
Confidence Interval (2-Sided) 90%
-3.43 to 1.41
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.4
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection PF-06372865 52.5 mg, Lorazepam 2 mg
Comments A mixed effects model was applied with fixed effects for period, time, treatment, and the interaction between treatment and time. Baseline was included as 2 separate covariates. The interaction between each baseline covariate and time were included as fixed effects. Participant was fitted as a random effect and time was fitted as a repeated effect within each participant × period. An unstructured correlation matrix was used. The effect reported is an average across all post-dose measurements.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Model Repeated Measures Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.2
Confidence Interval (2-Sided) 90%
-2.56 to 2.16
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.36
Estimation Comments [Not Specified]
2.Secondary Outcome
Title The SPR in the Eye Closure, Eyes Closed, and Eyes Open Condition
Hide Description The SPR was defined as the number of frequency steps between and including the lower and upper bound at which a generalized electroencephalogram (EEG) epileptiform activity had occurred, whereby subjects were exposed to 14 different frequencies ranging from 2 to 60 flashes per second. The SPR is then an integer score that ranges from 0 to 14 with lower scores representing better outcomes. The outcome measure was based on the average Least Squares Mean (LSmean) effect over the first 6 hours postdose.
Time Frame Pre-dose, 1, 2, 4 and 6 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set: all participants randomized and who had received at least 1 dose of randomized treatment and had at least 1 primary efficacy measurement in at least 1 study treatment period.
Arm/Group Title PF-06372865 17.5 mg PF-06372865 52.5 mg Lorazepam 2 mg Placebo
Hide Arm/Group Description:
One (1) lorazepam placebo tablet and seven (7) PF-06372865 2.5 mg tablets.
One (1) lorazepam placebo tablet and seven (7) PF-06372865 7.5 mg tablets.
One (1) lorazepam 2 mg tablet and seven (7) PF-06372865 placebo tablets.
One (1) lorazepam placebo tablet and seven (7) PF-06372865 placebo tablets.
Overall Number of Participants Analyzed 7 7 7 7
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Eye Closure Number Analyzed 7 participants 7 participants 7 participants 7 participants
0.57  (0.98) 1.38  (0.96) 1.58  (0.97) 6.80  (0.96)
Eyes Closed Number Analyzed 7 participants 7 participants 7 participants 6 participants
0.33  (0.57) 0.40  (0.57) 1.09  (0.57) 6.84  (0.64)
Eyes Open Number Analyzed 7 participants 7 participants 7 participants 6 participants
0.04  (0.46) 0.09  (0.46) 0.08  (0.46) 4.46  (0.51)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-06372865 17.5 mg, Placebo
Comments In eye closure condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Model Repeated Measure Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -6.23
Confidence Interval (2-Sided) 90%
-8.60 to -3.86
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.37
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PF-06372865 52.5 mg, Placebo
Comments In eye closure condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Model Repeated Measures Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -5.42
Confidence Interval (2-Sided) 90%
-7.78 to -3.06
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.36
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Lorazepam 2 mg, Placebo
Comments In eye closure condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Model Repeated Measures Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -5.22
Confidence Interval (2-Sided) 90%
-7.60 to -2.84
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.37
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PF-06372865 17.5 mg, PF-06372865 52.5 mg
Comments In eye closure condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Model Repeated Measures Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.81
Confidence Interval (2-Sided) 90%
-1.58 to 3.20
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.38
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection PF-06372865 17.5 mg, Lorazepam 2 mg
Comments In eye closure condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Model Repeated Measures Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.01
Confidence Interval (2-Sided) 90%
-3.43 to 1.41
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.4
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection PF-06372865 52.5 mg, Lorazepam 2 mg
Comments In eye closure condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Model Repeated Measures Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.2
Confidence Interval (2-Sided) 90%
-2.56 to 2.16
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.36
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection PF-06372865 17.5 mg, Placebo
Comments In eyes closed condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Model Repeated Measures Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -6.51
Confidence Interval (2-Sided) 90%
-8.01 to -5.01
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.79
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection PF-06372865 52.5 mg, Placebo
Comments In eyes closed condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Model Repeated Measures Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -6.44
Confidence Interval (2-Sided) 90%
-7.93 to -4.95
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.78
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Lorazepam 2 mg, Placebo
Comments In eyes closed condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Model Repeated Measures Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -5.74
Confidence Interval (2-Sided) 90%
-7.20 to -4.28
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.76
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection PF-06372865 17.5 mg, PF-06372865 52.5 mg
Comments In eyes closed condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Model Repeated Measures Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.07
Confidence Interval (2-Sided) 90%
-1.31 to 1.46
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.72
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection PF-06372865 17.5 mg, Lorazepam 2 mg
Comments In eyes closed condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Model Repeated Measures Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.77
Confidence Interval (2-Sided) 90%
-2.19 to 0.65
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.74
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection PF-06372865 52.5 mg, Lorazepam 2 mg
Comments In eyes closed condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Model Repeated Measures Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.7
Confidence Interval (2-Sided) 90%
-2.09 to 0.70
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.72
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection PF-06372865 17.5 mg, Placebo
Comments In eyes open condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Model Repeated Measures Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.42
Confidence Interval (2-Sided) 90%
-5.60 to -3.25
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.68
Estimation Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection PF-06372865 52.5 mg, Placebo
Comments In eyes open condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Model Repeated Measures Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.37
Confidence Interval (2-Sided) 90%
-5.57 to -3.17
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.69
Estimation Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Lorazepam 2 mg, Placebo
Comments In eyes open condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Model Repeated Measures Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.38
Confidence Interval (2-Sided) 90%
-5.57 to -3.19
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.69
Estimation Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection PF-06372865 17.5 mg, PF-06372865 52.5 mg
Comments In eyes open condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Model Repeated Measures Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.05
Confidence Interval (2-Sided) 90%
-1.08 to 1.19
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.66
Estimation Comments [Not Specified]
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection PF-06372865 17.5 mg, Lorazepam 2 mg
Comments In eyes open condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Model Repeated Measures Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.04
Confidence Interval (2-Sided) 90%
-1.18 to 1.10
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.66
Estimation Comments [Not Specified]
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection PF-06372865 52.5 mg, Lorazepam 2 mg
Comments In eyes open condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Model Repeated Measures Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.01
Confidence Interval (2-Sided) 90%
-1.11 to 1.13
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.65
Estimation Comments [Not Specified]
3.Secondary Outcome
Title The Percentage of Participants With Complete Suppression, Partial Response, and no Response to Intermittent Photic Stimulation (IPS)
Hide Description Complete suppression: SPR = 0 in all three eye conditions at the same time point. Partial response: A reduction in SPR of at least 3 units from baseline for at least 3 time points, and no time points with at least 3 units of increase, in the most sensitive eye condition; without meeting the complete suppression definition. No response: Did not meet complete suppression or partial response definitions.
Time Frame Pre-dose, 1, 2, 4 and 6 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set: all participants randomized and who had received at least 1 dose of randomized treatment and had at least 1 primary efficacy measurement in at least 1 study treatment period.
Arm/Group Title PF-06372865 17.5 mg PF-06372865 52.5 mg Lorazepam 2 mg Placebo
Hide Arm/Group Description:
One (1) lorazepam placebo tablet and seven (7) PF-06372865 2.5 mg tablets.
One (1) lorazepam placebo tablet and seven (7) PF-06372865 7.5 mg tablets.
One (1) lorazepam 2 mg tablet and seven (7) PF-06372865 placebo tablets.
One (1) lorazepam placebo tablet and seven (7) PF-06372865 placebo tablets.
Overall Number of Participants Analyzed 7 7 7 7
Measure Type: Number
Unit of Measure: Percentage of participants
Complete suppression 85.7 85.7 85.7 28.6
Partial response 0 0 0 0
No response 14.3 14.3 14.3 71.4
4.Secondary Outcome
Title Maximum Plasma Concentration (Cmax) of PF-06372865
Hide Description [Not Specified]
Time Frame 1, 2, 4 and 6 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants treated who had at least 1 measureable concentration in the respective study dose period.
Arm/Group Title PF-06372865 17.5 mg PF-06372865 52.5 mg
Hide Arm/Group Description:
One (1) lorazepam placebo tablet and seven (7) PF-06372865 2.5 mg tablets.
One (1) lorazepam placebo tablet and seven (7) PF-06372865 7.5 mg tablets.
Overall Number of Participants Analyzed 7 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
81.30
(23%)
200.6
(45%)
5.Secondary Outcome
Title Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-06372865
Hide Description [Not Specified]
Time Frame Pre-dose, 1, 2, 3, 4 and 6 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants treated who had at least 1 measureable concentration in the respective study dose period.
Arm/Group Title PF-06372865 17.5 mg PF-06372865 52.5 mg
Hide Arm/Group Description:
One (1) lorazepam placebo tablet and seven (7) PF-06372865 2.5 mg tablets.
One (1) lorazepam placebo tablet and seven (7) PF-06372865 7.5 mg tablets.
Overall Number of Participants Analyzed 7 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*hr/mL
331.3
(22%)
771.4
(56%)
6.Secondary Outcome
Title Time for Cmax (Tmax) of PF-06372865
Hide Description [Not Specified]
Time Frame 1, 2, 4 and 6 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants treated who had at least 1 measureable concentration in the respective study dose period.
Arm/Group Title PF-06372865 17.5 mg PF-06372865 52.5 mg
Hide Arm/Group Description:
One (1) lorazepam placebo tablet and seven (7) PF-06372865 2.5 mg tablets.
One (1) lorazepam placebo tablet and seven (7) PF-06372865 7.5 mg tablets.
Overall Number of Participants Analyzed 7 7
Median (Full Range)
Unit of Measure: hour
2.12
(1.02 to 3.03)
3.02
(1.98 to 5.95)
7.Secondary Outcome
Title Plasma Concentration of Lorazepam
Hide Description [Not Specified]
Time Frame 1, 2, 3, 4 and 6 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants treated who had at least 1 measureable concentration in the respective study dose period.
Arm/Group Title Lorazepam 2 mg
Hide Arm/Group Description:
One (1) lorazepam 2 mg tablet and seven (7) PF-06372865 placebo tablets.
Overall Number of Participants Analyzed 7
Mean (Standard Deviation)
Unit of Measure: ng/mL
1 hours post dose Number Analyzed 5 participants
7.38  (5.92)
2 hours post dose Number Analyzed 7 participants
13.32  (6.67)
3 hours post dose Number Analyzed 7 participants
17.10  (4.32)
4 hours post dose Number Analyzed 7 participants
17.87  (2.97)
6 hours post dose Number Analyzed 7 participants
15.93  (1.92)
8.Secondary Outcome
Title Number of Participants With Clinically Significant Laboratory Test Abnormalities
Hide Description Safety laboratory tests included hematological, clinical chemistry (serum) and urinalysis safety tests.
Time Frame 17 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Analysis Set included all participants who received at least 1 dose of investigational product in the respective study treatment period.
Arm/Group Title PF-06372865 17.5 mg PF-06372865 52.5 mg Lorazepam 2 mg Placebo
Hide Arm/Group Description:
One (1) lorazepam placebo tablet and seven (7) PF-06372865 2.5 mg tablets.
One (1) lorazepam placebo tablet and seven (7) PF-06372865 7.5 mg tablets.
One (1) lorazepam 2 mg tablet and seven (7) PF-06372865 placebo tablets.
One (1) lorazepam placebo tablet and seven (7) PF-06372865 placebo tablets.
Overall Number of Participants Analyzed 7 7 7 7
Measure Type: Number
Unit of Measure: Participants
0 0 0 0
9.Secondary Outcome
Title Number of Participants With Clinically Significant Change From Baseline in Blood Pressure and Pulse Rate
Hide Description [Not Specified]
Time Frame 17 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Analysis Set included all participants who received at least 1 dose of investigational product in the respective study treatment period.
Arm/Group Title PF-06372865 17.5 mg PF-06372865 52.5 mg Lorazepam 2 mg Placebo
Hide Arm/Group Description:
One (1) lorazepam placebo tablet and seven (7) PF-06372865 2.5 mg tablets.
One (1) lorazepam placebo tablet and seven (7) PF-06372865 7.5 mg tablets.
One (1) lorazepam 2 mg tablet and seven (7) PF-06372865 placebo tablets.
One (1) lorazepam placebo tablet and seven (7) PF-06372865 placebo tablets.
Overall Number of Participants Analyzed 7 7 7 7
Measure Type: Number
Unit of Measure: Participants
0 0 0 0
10.Secondary Outcome
Title Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings
Hide Description [Not Specified]
Time Frame 17 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Analysis Set included all participants who received at least 1 dose of investigational product in the respective study treatment period.
Arm/Group Title PF-06372865 17.5 mg PF-06372865 52.5 mg Lorazepam 2 mg Placebo
Hide Arm/Group Description:
One (1) lorazepam placebo tablet and seven (7) PF-06372865 2.5 mg tablets.
One (1) lorazepam placebo tablet and seven (7) PF-06372865 7.5 mg tablets.
One (1) lorazepam 2 mg tablet and seven (7) PF-06372865 placebo tablets.
One (1) lorazepam placebo tablet and seven (7) PF-06372865 placebo tablets.
Overall Number of Participants Analyzed 7 7 7 7
Measure Type: Number
Unit of Measure: Participants
0 0 0 0
11.Secondary Outcome
Title Number of Participants With Treatment-emergent Adverse Events (AEs)
Hide Description The all causalities treatment-emergent AEs by System Organ Class and Preferred Term in >5% of subjects. AEs included serious AEs and non-serious AEs.
Time Frame 19 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Analysis Set included all participants who received at least 1 dose of investigational product in the respective study treatment period.
Arm/Group Title PF-06372865 17.5 mg PF-06372865 52.5 mg Lorazepam 2 mg Placebo
Hide Arm/Group Description:
One (1) lorazepam placebo tablet and seven (7) PF-06372865 2.5 mg tablets.
One (1) lorazepam placebo tablet and seven (7) PF-06372865 7.5 mg tablets.
One (1) lorazepam 2 mg tablet and seven (7) PF-06372865 placebo tablets.
One (1) lorazepam placebo tablet and seven (7) PF-06372865 placebo tablets.
Overall Number of Participants Analyzed 7 7 7 7
Measure Type: Number
Unit of Measure: Participants
Treatment-emergent non serious AEs 4 6 6 5
Treatment-emergent serious AEs 0 0 0 0
Time Frame 19 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo PF-06372865 17.5 mg PF-06372865 52.5 mg Lorazepam 2 mg
Hide Arm/Group Description One (1) lorazepam placebo tablet and seven (7) PF-06372865 placebo tablets. One (1) lorazepam placebo tablet and seven (7) PF-06372865 2.5 mg tablets. One (1) lorazepam placebo tablet and seven (7) PF-06372865 7.5 mg tablets. One (1) lorazepam 2 mg tablet and seven (7) PF-06372865 placebo tablets.
All-Cause Mortality
Placebo PF-06372865 17.5 mg PF-06372865 52.5 mg Lorazepam 2 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   0/7 (0.00%)   0/7 (0.00%)   0/7 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo PF-06372865 17.5 mg PF-06372865 52.5 mg Lorazepam 2 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   0/7 (0.00%)   0/7 (0.00%)   0/7 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo PF-06372865 17.5 mg PF-06372865 52.5 mg Lorazepam 2 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/7 (57.14%)   6/7 (85.71%)   6/7 (85.71%)   5/7 (71.43%) 
Eye disorders         
Vision blurred * 1  0/7 (0.00%)  0/7 (0.00%)  1/7 (14.29%)  0/7 (0.00%) 
Gastrointestinal disorders         
Abdominal pain upper * 1  1/7 (14.29%)  0/7 (0.00%)  0/7 (0.00%)  0/7 (0.00%) 
Nausea * 1  1/7 (14.29%)  0/7 (0.00%)  1/7 (14.29%)  0/7 (0.00%) 
Vomiting * 1  1/7 (14.29%)  1/7 (14.29%)  1/7 (14.29%)  0/7 (0.00%) 
General disorders         
Fatigue * 1  0/7 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/7 (14.29%) 
Feeling hot * 1  0/7 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/7 (0.00%) 
Pain * 1  0/7 (0.00%)  0/7 (0.00%)  1/7 (14.29%)  0/7 (0.00%) 
Infections and infestations         
Pharyngitis * 1  0/7 (0.00%)  1/7 (14.29%)  1/7 (14.29%)  0/7 (0.00%) 
Upper respiratory tract infection * 1  1/7 (14.29%)  0/7 (0.00%)  0/7 (0.00%)  1/7 (14.29%) 
Musculoskeletal and connective tissue disorders         
Muscular weakness * 1  0/7 (0.00%)  0/7 (0.00%)  1/7 (14.29%)  0/7 (0.00%) 
Nervous system disorders         
Balance disorder * 1  0/7 (0.00%)  0/7 (0.00%)  1/7 (14.29%)  0/7 (0.00%) 
Disturbance in attention * 1  1/7 (14.29%)  1/7 (14.29%)  1/7 (14.29%)  0/7 (0.00%) 
Dizziness * 1  0/7 (0.00%)  3/7 (42.86%)  3/7 (42.86%)  1/7 (14.29%) 
Dysarthria * 1  0/7 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/7 (0.00%) 
Dysgeusia * 1  0/7 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/7 (0.00%) 
Headache * 1  0/7 (0.00%)  1/7 (14.29%)  1/7 (14.29%)  0/7 (0.00%) 
Lethargy * 1  0/7 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/7 (0.00%) 
Somnolence * 1  3/7 (42.86%)  3/7 (42.86%)  4/7 (57.14%)  3/7 (42.86%) 
Psychiatric disorders         
Euphoric mood * 1  0/7 (0.00%)  0/7 (0.00%)  1/7 (14.29%)  1/7 (14.29%) 
Irritability * 1  0/7 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/7 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Oropharyngeal pain * 1  0/7 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/7 (14.29%) 
Rhinorrhoea * 1  0/7 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/7 (14.29%) 
Skin and subcutaneous tissue disorders         
Rash pruritic * 1  0/7 (0.00%)  0/7 (0.00%)  1/7 (14.29%)  0/7 (0.00%) 
1
Term from vocabulary, MedDRA 19.1
*
Indicates events were collected by non-systematic assessment
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.
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
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02564029     History of Changes
Other Study ID Numbers: B7431005
First Submitted: September 10, 2015
First Posted: September 30, 2015
Results First Submitted: December 21, 2017
Results First Posted: March 14, 2018
Last Update Posted: March 14, 2018