Trial · NCT02564029

PF-06372865 in Subjects With Photosensitive Epilepsy

NCT02564029, Phase 2, Completed, Pfizer; results first posted 2018-03-14

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. PF-06372865 in Subjects With Photosensitive Epilepsy. Trials, record NCT02564029. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02564029

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: PF-06372865 in Subjects With Photosensitive Epilepsy
NCT number: NCT02564029
Status: Completed
Phases: Phase 2
Enrollment: 7 participants, actual
Lead sponsor: Pfizer
Conditions: Reflex Epilepsy, Photosensitive
Interventions: PF-06372865, Placebo, Lorazepam
First posted: 2015-09-30
Last updated: 2018-03-14
Results first posted: 2018-03-14

Source ClinicalTrials.gov

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	The Standardized Photosensitivity Range (SPR) in the Subject's Most Sensitive Eye Condition	Pre-dose, 1, 2, 4 and 6 hours post-dose	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.
Secondary	The SPR in the Eye Closure, Eyes Closed, and Eyes Open Condition	Pre-dose, 1, 2, 4 and 6 hours post-dose	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.
Secondary	The Percentage of Participants With Complete Suppression, Partial Response, and no Response to Intermittent Photic Stimulation (IPS)	Pre-dose, 1, 2, 4 and 6 hours post-dose	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.
Secondary	Maximum Plasma Concentration (Cmax) of PF-06372865	1, 2, 4 and 6 hours post-dose
Secondary	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
Secondary	Time for Cmax (Tmax) of PF-06372865	1, 2, 4 and 6 hours post-dose
Secondary	Plasma Concentration of Lorazepam	1, 2, 3, 4 and 6 hours post-dose
Secondary	Number of Participants With Clinically Significant Laboratory Test Abnormalities	17 weeks	Safety laboratory tests included hematological, clinical chemistry (serum) and urinalysis safety tests.
Secondary	Number of Participants With Clinically Significant Change From Baseline in Blood Pressure and Pulse Rate	17 weeks
Secondary	Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings	17 weeks

1 to 10 of 11Source ClinicalTrials.gov

See all 11 registered outcomes

Outcomes11

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	The Standardized Photosensitivity Range (SPR) in the Subject's Most Sensitive Eye Condition	Pre-dose, 1, 2, 4 and 6 hours post-dose	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.	Units on a scale	LEAST_SQUARES_MEAN
SECONDARY	The SPR in the Eye Closure, Eyes Closed, and Eyes Open Condition	Pre-dose, 1, 2, 4 and 6 hours post-dose	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.	Units on a scale	LEAST_SQUARES_MEAN
SECONDARY	The Percentage of Participants With Complete Suppression, Partial Response, and no Response to Intermittent Photic Stimulation (IPS)	Pre-dose, 1, 2, 4 and 6 hours post-dose	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.	Percentage of participants	NUMBER
SECONDARY	Maximum Plasma Concentration (Cmax) of PF-06372865	1, 2, 4 and 6 hours post-dose	All enrolled participants treated who had at least 1 measureable concentration in the respective study dose period.	ng/mL	GEOMETRIC_MEAN
SECONDARY	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	All enrolled participants treated who had at least 1 measureable concentration in the respective study dose period.	ng*hr/mL	GEOMETRIC_MEAN
SECONDARY	Time for Cmax (Tmax) of PF-06372865	1, 2, 4 and 6 hours post-dose	All enrolled participants treated who had at least 1 measureable concentration in the respective study dose period.	hour	MEDIAN
SECONDARY	Plasma Concentration of Lorazepam	1, 2, 3, 4 and 6 hours post-dose	All enrolled participants treated who had at least 1 measureable concentration in the respective study dose period.	ng/mL	MEAN
SECONDARY	Number of Participants With Clinically Significant Laboratory Test Abnormalities	17 weeks	The Safety Analysis Set included all participants who received at least 1 dose of investigational product in the respective study treatment period.	Participants	NUMBER
SECONDARY	Number of Participants With Clinically Significant Change From Baseline in Blood Pressure and Pulse Rate	17 weeks	The Safety Analysis Set included all participants who received at least 1 dose of investigational product in the respective study treatment period.	Participants	NUMBER
SECONDARY	Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings	17 weeks	The Safety Analysis Set included all participants who received at least 1 dose of investigational product in the respective study treatment period.	Participants	NUMBER

1 to 10 of 11Source ClinicalTrials.gov

See all 11 outcomes

Results by group59

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
The Standardized Photosensitivity Range (SPR) in the Subject's Most Sensitive Eye Condition	PF-06372865 17.5 mg		0.57	Standard Error 0.98	Units on a scale
The Standardized Photosensitivity Range (SPR) in the Subject's Most Sensitive Eye Condition	PF-06372865 52.5 mg		1.38	Standard Error 0.96	Units on a scale
The Standardized Photosensitivity Range (SPR) in the Subject's Most Sensitive Eye Condition	Lorazepam 2 mg		1.58	Standard Error 0.97	Units on a scale
The Standardized Photosensitivity Range (SPR) in the Subject's Most Sensitive Eye Condition	Placebo		6.80	Standard Error 0.96	Units on a scale
The SPR in the Eye Closure, Eyes Closed, and Eyes Open Condition	PF-06372865 17.5 mg	Eye Closure	0.57	Standard Error 0.98	Units on a scale
The SPR in the Eye Closure, Eyes Closed, and Eyes Open Condition	PF-06372865 52.5 mg	Eye Closure	1.38	Standard Error 0.96	Units on a scale
The SPR in the Eye Closure, Eyes Closed, and Eyes Open Condition	Lorazepam 2 mg	Eye Closure	1.58	Standard Error 0.97	Units on a scale
The SPR in the Eye Closure, Eyes Closed, and Eyes Open Condition	Placebo	Eye Closure	6.80	Standard Error 0.96	Units on a scale
The SPR in the Eye Closure, Eyes Closed, and Eyes Open Condition	PF-06372865 17.5 mg	Eyes Closed	0.33	Standard Error 0.57	Units on a scale
The SPR in the Eye Closure, Eyes Closed, and Eyes Open Condition	PF-06372865 52.5 mg	Eyes Closed	0.40	Standard Error 0.57	Units on a scale

1 to 10 of 59Source ClinicalTrials.gov

See all 59 results by group

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	All Study Participants	7
Overall Study	COMPLETED	All Study Participants	7
Overall Study	NOT COMPLETED	All Study Participants	0

Source ClinicalTrials.gov

Adverse events92

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Vision blurred	Eye disorders	Placebo	0	7
other	Vision blurred	Eye disorders	PF-06372865 17.5 mg	0	7
other	Vision blurred	Eye disorders	PF-06372865 52.5 mg	1	7
other	Vision blurred	Eye disorders	Lorazepam 2 mg	0	7
other	Abdominal pain upper	Gastrointestinal disorders	Placebo	1	7
other	Abdominal pain upper	Gastrointestinal disorders	PF-06372865 17.5 mg	0	7
other	Abdominal pain upper	Gastrointestinal disorders	PF-06372865 52.5 mg	0	7
other	Abdominal pain upper	Gastrointestinal disorders	Lorazepam 2 mg	0	7
other	Nausea	Gastrointestinal disorders	Placebo	1	7
other	Nausea	Gastrointestinal disorders	PF-06372865 17.5 mg	0	7

1 to 10 of 92Source ClinicalTrials.gov

See all 92 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	7
Total, all-cause mortality	PF-06372865 17.5 mg	0	7
Total, all-cause mortality	PF-06372865 52.5 mg	0	7
Total, all-cause mortality	Lorazepam 2 mg	0	7
Total, other adverse events	Placebo	4	7
Total, other adverse events	PF-06372865 17.5 mg	6	7
Total, other adverse events	PF-06372865 52.5 mg	6	7
Total, other adverse events	Lorazepam 2 mg	5	7
Total, serious adverse events	Placebo	0	7
Total, serious adverse events	PF-06372865 17.5 mg	0	7

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
30877186	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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Read this trial from software.

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