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PF-06372865 in subjects with photosensitive epilepsy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-06372865 dose level 1 | Experimental | 17.5 milligram (mg) single dose |
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| PF-06372865 dose level 2 | Experimental | 52.5 mg single dose |
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| Placebo | Placebo Comparator | Single dose |
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| Lorazepam | Active Comparator | 2mg single dose |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06372865 | Drug | Single dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The Standardized Photosensitivity Range (SPR) in the Subject's Most Sensitive Eye Condition | 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. | Pre-dose, 1, 2, 4 and 6 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| The SPR in the Eye Closure, Eyes Closed, and Eyes Open Condition | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Consultants in Epilepsy & Neurology, PLLC | Boise | Idaho | 83702 | United States | ||
| Johns Hopkins University Department of Neurology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30877186 | Derived | Gurrell R, Gorman D, Whitlock M, Ogden A, Reynolds DS, DiVentura B, Abou-Khalil B, Gelfand M, Pollard J, Hogan RE, Krauss G, Sperling M, Vazquez B, Wechsler RT, Friedman D, Butt RP, French J. Photosensitive epilepsy: Robust clinical efficacy of a selective GABA potentiator. Neurology. 2019 Apr 9;92(15):e1786-e1795. doi: 10.1212/WNL.0000000000007271. Epub 2019 Mar 15. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Study Participants | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo |
| Drug |
Placebo for PF-06372865 and placebo for lorazepam |
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| Lorazepam | Drug | 2 mg single oral dose |
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| Pre-dose, 1, 2, 4 and 6 hours post-dose |
| The Percentage of Participants With Complete Suppression, Partial Response, and no Response to Intermittent Photic Stimulation (IPS) | 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. | Pre-dose, 1, 2, 4 and 6 hours post-dose |
| Maximum Plasma Concentration (Cmax) of PF-06372865 | 1, 2, 4 and 6 hours post-dose |
| Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-06372865 | Pre-dose, 1, 2, 3, 4 and 6 hours post-dose |
| Time for Cmax (Tmax) of PF-06372865 | 1, 2, 4 and 6 hours post-dose |
| Plasma Concentration of Lorazepam | 1, 2, 3, 4 and 6 hours post-dose |
| Number of Participants With Clinically Significant Laboratory Test Abnormalities | Safety laboratory tests included hematological, clinical chemistry (serum) and urinalysis safety tests. | 17 weeks |
| Number of Participants With Clinically Significant Change From Baseline in Blood Pressure and Pulse Rate | 17 weeks |
| Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings | 17 weeks |
| Number of Participants With Treatment-emergent Adverse Events (AEs) | 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. | 19 weeks |
| Baltimore |
| Maryland |
| 21287-7247 |
| United States |
| Barnes Jewish Hospital | St Louis | Missouri | 63110 | United States |
| Center for Advanced Medicine | St Louis | Missouri | 63110 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| New York University Comprehensive Epilepsy Center | New York | New York | 10016 | United States |
| Clinical and Translational Research Center | Philadelphia | Pennsylvania | 19104 | United States |
| Hospital of the Univ of PA Pharmacy Service | Philadelphia | Pennsylvania | 19104 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Thomas Jefferson University Comprehensive Epilepsy Center | Philadelphia | Pennsylvania | 19107 | United States |
| Thomas Jefferson University Hospital EEG lab | Philadelphia | Pennsylvania | 19107 | United States |
| Thomas Jefferson University Investigational Drug Service | Philadelphia | Pennsylvania | 19107 | United States |
| General Clinical Research Center (GCRC) | Nashville | Tennessee | 37232 | United States |
| Vanderbilt University Epilepsy Clinic | Nashville | Tennessee | 37232 | United States |
| Vanderbilt University Hospital Pharmacy | Nashville | Tennessee | 37232 | United States |
| VU Department of Neurology | Nashville | Tennessee | 37232 | United States |
| COMPLETED |
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| NOT COMPLETED |
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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.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | A total of 7 participants were enrolled and assigned to study treatment. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Standardized Photosensitivity Range (SPR) in the Subject's Most Sensitive Eye Condition | 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. | 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. | Posted | Least Squares Mean | Standard Error | Units on a scale | Pre-dose, 1, 2, 4 and 6 hours post-dose |
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| Secondary | The SPR in the Eye Closure, Eyes Closed, and Eyes Open Condition | 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. | 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. | Posted | Least Squares Mean | Standard Error | Units on a scale | Pre-dose, 1, 2, 4 and 6 hours post-dose |
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| Secondary | The Percentage of Participants With Complete Suppression, Partial Response, and no Response to Intermittent Photic Stimulation (IPS) | 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. | 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. | Posted | Number | Percentage of participants | Pre-dose, 1, 2, 4 and 6 hours post-dose |
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| Secondary | Maximum Plasma Concentration (Cmax) of PF-06372865 | All enrolled participants treated who had at least 1 measureable concentration in the respective study dose period. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 1, 2, 4 and 6 hours post-dose |
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| Secondary | Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-06372865 | All enrolled participants treated who had at least 1 measureable concentration in the respective study dose period. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Pre-dose, 1, 2, 3, 4 and 6 hours post-dose |
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| Secondary | Time for Cmax (Tmax) of PF-06372865 | All enrolled participants treated who had at least 1 measureable concentration in the respective study dose period. | Posted | Median | Full Range | hour | 1, 2, 4 and 6 hours post-dose |
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| Secondary | Plasma Concentration of Lorazepam | All enrolled participants treated who had at least 1 measureable concentration in the respective study dose period. | Posted | Mean | Standard Deviation | ng/mL | 1, 2, 3, 4 and 6 hours post-dose |
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| Secondary | Number of Participants With Clinically Significant Laboratory Test Abnormalities | Safety laboratory tests included hematological, clinical chemistry (serum) and urinalysis safety tests. | The Safety Analysis Set included all participants who received at least 1 dose of investigational product in the respective study treatment period. | Posted | Number | Participants | 17 weeks |
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| Secondary | Number of Participants With Clinically Significant Change From Baseline in Blood Pressure and Pulse Rate | The Safety Analysis Set included all participants who received at least 1 dose of investigational product in the respective study treatment period. | Posted | Number | Participants | 17 weeks |
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| Secondary | Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings | The Safety Analysis Set included all participants who received at least 1 dose of investigational product in the respective study treatment period. | Posted | Number | Participants | 17 weeks |
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| Secondary | Number of Participants With Treatment-emergent Adverse Events (AEs) | 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. | The Safety Analysis Set included all participants who received at least 1 dose of investigational product in the respective study treatment period. | Posted | Number | Participants | 19 weeks |
|
19 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | One (1) lorazepam placebo tablet and seven (7) PF-06372865 placebo tablets. | 0 | 7 | 0 | 7 | 4 | 7 |
| EG001 | PF-06372865 17.5 mg | One (1) lorazepam placebo tablet and seven (7) PF-06372865 2.5 mg tablets. | 0 | 7 | 0 | 7 | 6 | 7 |
| EG002 | PF-06372865 52.5 mg | One (1) lorazepam placebo tablet and seven (7) PF-06372865 7.5 mg tablets. | 0 | 7 | 0 | 7 | 6 | 7 |
| EG003 | Lorazepam 2 mg | One (1) lorazepam 2 mg tablet and seven (7) PF-06372865 placebo tablets. | 0 | 7 | 0 | 7 | 5 | 7 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vision blurred | Eye disorders | MedDRA 19.1 | Non-systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA 19.1 | Non-systematic Assessment |
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| Feeling hot | General disorders | MedDRA 19.1 | Non-systematic Assessment |
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| Pain | General disorders | MedDRA 19.1 | Non-systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
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| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Non-systematic Assessment |
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| Balance disorder | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
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| Disturbance in attention | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
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| Dysarthria | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
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| Lethargy | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
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| Euphoric mood | Psychiatric disorders | MedDRA 19.1 | Non-systematic Assessment |
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| Irritability | Psychiatric disorders | MedDRA 19.1 | Non-systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Non-systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Non-systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D020195 | Epilepsy, Reflex |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C000630159 | PF-06372865 |
| D008140 | Lorazepam |
| ID | Term |
|---|---|
| D001570 | Benzodiazepinones |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| 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. | Mixed Model Repeated Measures Analysis | Mean Difference (Final Values) | -5.42 | Standard Error of the Mean | 1.36 | 2-Sided | 90 | -7.78 | -3.06 | Other |
| 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. | Mixed Model Repeated Measures Analysis | Mean Difference (Final Values) | -5.22 | Standard Error of the Mean | 1.37 | 2-Sided | 90 | -7.60 | -2.84 | Other |
| 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. | Mixed Model Repeated Measures Analysis | Mean Difference (Final Values) | 0.81 | Standard Error of the Mean | 1.38 | 2-Sided | 90 | -1.58 | 3.20 | Other |
| 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. | Mixed Model Repreated Measure Analysis | Mean Difference (Final Values) | -1.01 | Standard Error of the Mean | 1.4 | 2-Sided | 90 | -3.43 | 1.41 | Other |
| 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. | Mixed Model Repeated Measures Analysis | Mean Difference (Final Values) | -0.2 | Standard Error of the Mean | 1.36 | 2-Sided | 90 | -2.56 | 2.16 | Other |
| OG003 | Placebo | One (1) lorazepam placebo tablet and seven (7) PF-06372865 placebo tablets. |
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| OG003 | Placebo | One (1) lorazepam placebo tablet and seven (7) PF-06372865 placebo tablets. |
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