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CompletedNCT02564029Updated Mar 14, 2018Results posted

PF-06372865 in Subjects With Photosensitive Epilepsy

A Phase 2 interventional study of PF-06372865 and Placebo in Reflex Epilepsy, Photosensitive, sponsored by Pfizer. Completed at 16 sites in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2018-03-14.

Sponsored by Pfizer · Phase 2, Interventional, and Basic science

Phase
Phase 2
Study type
Interventional
Enrollment
7
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

PF-06372865 in subjects with photosensitive epilepsy

02

Conditions studied

  • Reflex Epilepsy, Photosensitive

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03

In context

Epilepsy

1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.

This study's enrollment of 7 is below the median of 50 across 1,206 interventional studies indexed under Epilepsy.

Browse Epilepsy studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • A diagnosis and history of photoparoxysmal response on electroencephalogram (EEG) with or without a diagnosis of epilepsy for which subjects are taking up to 0 - 2 concomitant antiepileptic drugs.
  • Subjects currently taking antiepileptic drug(s) to be on a stable dose for 4 weeks prior to Screening Visit.
  • A minimum average standardized photosensitive range (SPR) across all screening timepoints of 4 in the most sensitive eye condition and a non-zero average in at least one other eye condition.

Exclusion criteria

Exclusion Criteria:

  • Subjects with a history of status epilepticus.
  • Subjects who have experienced a generalized tonic-clonic convulsion in the past 6 months, at the time of the initial screening visit.
05

Study design

Phase
Phase 2
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
7 participants (actual)

Study arms

  • Experimental
    PF-06372865 dose level 1

    17.5 milligram (mg) single dose

    Drug: PF-06372865

  • Experimental
    PF-06372865 dose level 2

    52.5 mg single dose

    Drug: PF-06372865

  • Placebo comparator
    Placebo

    Single dose

    Drug: Placebo

  • Active comparator
    Lorazepam

    2mg single dose

    Drug: Lorazepam

Interventions

  • DrugPF-06372865

    Single dose

  • DrugPlacebo

    Placebo for PF-06372865 and placebo for lorazepam

  • DrugLorazepam

    2 mg single oral dose

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Pre-dose, 1, 2, 4 and 6 hours post-dose

Secondary outcomes

  1. 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.

    Time frame: Pre-dose, 1, 2, 4 and 6 hours post-dose

  2. 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.

    Time frame: Pre-dose, 1, 2, 4 and 6 hours post-dose

  3. Maximum Plasma Concentration (Cmax) of PF-06372865

    Time frame: 1, 2, 4 and 6 hours post-dose

  4. Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-06372865

    Time frame: Pre-dose, 1, 2, 3, 4 and 6 hours post-dose

  5. Time for Cmax (Tmax) of PF-06372865

    Time frame: 1, 2, 4 and 6 hours post-dose

  6. Plasma Concentration of Lorazepam

    Time frame: 1, 2, 3, 4 and 6 hours post-dose

  7. Number of Participants With Clinically Significant Laboratory Test Abnormalities

    Safety laboratory tests included hematological, clinical chemistry (serum) and urinalysis safety tests.

    Time frame: 17 weeks

  8. Number of Participants With Clinically Significant Change From Baseline in Blood Pressure and Pulse Rate

    Time frame: 17 weeks

  9. Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings

    Time frame: 17 weeks

  10. 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.

    Time frame: 19 weeks

07

Results

Posted Mar 14, 2018

Participant flow

Participant flow — Overall Study
MilestoneAll Study Participants
Started7
Completed7
Not completed0

Outcome measures

PrimaryThe 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.

Time frame:
Pre-dose, 1, 2, 4 and 6 hours post-dose
Reported as:
Least squares mean · Units on a scale
The Standardized Photosensitivity Range (SPR) in the Subject's Most Sensitive Eye Condition
Units on a scalePF-06372865 17.5 mgPF-06372865 52.5 mgLorazepam 2 mgPlacebo
The Standardized Photosensitivity Range (SPR) in the Subject's Most Sensitive Eye Condition0.57 ± 0.981.38 ± 0.961.58 ± 0.976.80 ± 0.96
Statistical analysis
  • PF-06372865 17.5 mg vs Placebo · Mixed Model Repeated Measures Analysis · Mean difference (final values): -6.23 · 90% CI -8.60 to -3.86
  • PF-06372865 52.5 mg vs Placebo · Mixed Model Repeated Measures Analysis · Mean difference (final values): -5.42 · 90% CI -7.78 to -3.06
  • Lorazepam 2 mg vs Placebo · Mixed Model Repeated Measures Analysis · Mean difference (final values): -5.22 · 90% CI -7.60 to -2.84
  • PF-06372865 17.5 mg vs PF-06372865 52.5 mg · Mixed Model Repeated Measures Analysis · Mean difference (final values): 0.81 · 90% CI -1.58 to 3.20
  • PF-06372865 17.5 mg vs Lorazepam 2 mg · Mixed Model Repreated Measure Analysis · Mean difference (final values): -1.01 · 90% CI -3.43 to 1.41
  • PF-06372865 52.5 mg vs Lorazepam 2 mg · Mixed Model Repeated Measures Analysis · Mean difference (final values): -0.2 · 90% CI -2.56 to 2.16
SecondaryThe 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.

Time frame:
Pre-dose, 1, 2, 4 and 6 hours post-dose
Reported as:
Least squares mean · Units on a scale
The SPR in the Eye Closure, Eyes Closed, and Eyes Open Condition
Units on a scalePF-06372865 17.5 mgPF-06372865 52.5 mgLorazepam 2 mgPlacebo
Eye Closure0.57 ± 0.981.38 ± 0.961.58 ± 0.976.80 ± 0.96
Eyes Closed0.33 ± 0.570.40 ± 0.571.09 ± 0.576.84 ± 0.64
Eyes Open0.04 ± 0.460.09 ± 0.460.08 ± 0.464.46 ± 0.51
Statistical analysis
  • PF-06372865 17.5 mg vs Placebo · Mixed Model Repeated Measure Analysis · Mean difference (final values): -6.23 · 90% CI -8.60 to -3.86
  • PF-06372865 52.5 mg vs Placebo · Mixed Model Repeated Measures Analysis · Mean difference (final values): -5.42 · 90% CI -7.78 to -3.06
  • Lorazepam 2 mg vs Placebo · Mixed Model Repeated Measures Analysis · Mean difference (final values): -5.22 · 90% CI -7.60 to -2.84
  • PF-06372865 17.5 mg vs PF-06372865 52.5 mg · Mixed Model Repeated Measures Analysis · Mean difference (final values): 0.81 · 90% CI -1.58 to 3.20
  • PF-06372865 17.5 mg vs Lorazepam 2 mg · Mixed Model Repeated Measures Analysis · Mean difference (final values): -1.01 · 90% CI -3.43 to 1.41
  • PF-06372865 52.5 mg vs Lorazepam 2 mg · Mixed Model Repeated Measures Analysis · Mean difference (final values): -0.2 · 90% CI -2.56 to 2.16
  • PF-06372865 17.5 mg vs Placebo · Mixed Model Repeated Measures Analysis · Mean difference (final values): -6.51 · 90% CI -8.01 to -5.01
  • PF-06372865 52.5 mg vs Placebo · Mixed Model Repeated Measures Analysis · Mean difference (final values): -6.44 · 90% CI -7.93 to -4.95
  • Lorazepam 2 mg vs Placebo · Mixed Model Repeated Measures Analysis · Mean difference (final values): -5.74 · 90% CI -7.20 to -4.28
  • PF-06372865 17.5 mg vs PF-06372865 52.5 mg · Mixed Model Repeated Measures Analysis · Mean difference (final values): 0.07 · 90% CI -1.31 to 1.46
  • PF-06372865 17.5 mg vs Lorazepam 2 mg · Mixed Model Repeated Measures Analysis · Mean difference (final values): -0.77 · 90% CI -2.19 to 0.65
  • PF-06372865 52.5 mg vs Lorazepam 2 mg · Mixed Model Repeated Measures Analysis · Mean difference (final values): -0.7 · 90% CI -2.09 to 0.70
  • PF-06372865 17.5 mg vs Placebo · Mixed Model Repeated Measures Analysis · Mean difference (final values): -4.42 · 90% CI -5.60 to -3.25
  • PF-06372865 52.5 mg vs Placebo · Mixed Model Repeated Measures Analysis · Mean difference (final values): -4.37 · 90% CI -5.57 to -3.17
  • Lorazepam 2 mg vs Placebo · Mixed Model Repeated Measures Analysis · Mean difference (final values): -4.38 · 90% CI -5.57 to -3.19
  • PF-06372865 17.5 mg vs PF-06372865 52.5 mg · Mixed Model Repeated Measures Analysis · Mean difference (final values): 0.05 · 90% CI -1.08 to 1.19
  • PF-06372865 17.5 mg vs Lorazepam 2 mg · Mixed Model Repeated Measures Analysis · Mean difference (final values): -0.04 · 90% CI -1.18 to 1.10
  • PF-06372865 52.5 mg vs Lorazepam 2 mg · Mixed Model Repeated Measures Analysis · Mean difference (final values): 0.01 · 90% CI -1.11 to 1.13
SecondaryThe 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.

Time frame:
Pre-dose, 1, 2, 4 and 6 hours post-dose
Reported as:
Number · Percentage of participants
The Percentage of Participants With Complete Suppression, Partial Response, and no Response to Intermittent Photic Stimulation (IPS)
Percentage of participantsPF-06372865 17.5 mgPF-06372865 52.5 mgLorazepam 2 mgPlacebo
Complete suppression85.785.785.728.6
Partial response0000
No response14.314.314.371.4
SecondaryMaximum Plasma Concentration (Cmax) of PF-06372865
Time frame:
1, 2, 4 and 6 hours post-dose
Reported as:
Geometric mean · ng/mL
Maximum Plasma Concentration (Cmax) of PF-06372865
ng/mLPF-06372865 17.5 mgPF-06372865 52.5 mg
Maximum Plasma Concentration (Cmax) of PF-0637286581.30 ± 23200.6 ± 45
SecondaryArea Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-06372865
Time frame:
Pre-dose, 1, 2, 3, 4 and 6 hours post-dose
Reported as:
Geometric mean · ng*hr/mL
Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-06372865
ng*hr/mLPF-06372865 17.5 mgPF-06372865 52.5 mg
Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-06372865331.3 ± 22771.4 ± 56
SecondaryTime for Cmax (Tmax) of PF-06372865
Time frame:
1, 2, 4 and 6 hours post-dose
Reported as:
Median · hour
Time for Cmax (Tmax) of PF-06372865
hourPF-06372865 17.5 mgPF-06372865 52.5 mg
Time for Cmax (Tmax) of PF-063728652.12 ± 223.02 ± 56
SecondaryPlasma Concentration of Lorazepam
Time frame:
1, 2, 3, 4 and 6 hours post-dose
Reported as:
Mean · ng/mL
Plasma Concentration of Lorazepam
ng/mLLorazepam 2 mg
1 hours post dose7.38 ± 5.92
2 hours post dose13.32 ± 6.67
3 hours post dose17.10 ± 4.32
4 hours post dose17.87 ± 2.97
6 hours post dose15.93 ± 1.92
SecondaryNumber of Participants With Clinically Significant Laboratory Test Abnormalities

Safety laboratory tests included hematological, clinical chemistry (serum) and urinalysis safety tests.

Time frame:
17 weeks
Reported as:
Number · Participants
Number of Participants With Clinically Significant Laboratory Test Abnormalities
ParticipantsPF-06372865 17.5 mgPF-06372865 52.5 mgLorazepam 2 mgPlacebo
Number of Participants With Clinically Significant Laboratory Test Abnormalities0000
SecondaryNumber of Participants With Clinically Significant Change From Baseline in Blood Pressure and Pulse Rate
Time frame:
17 weeks
Reported as:
Number · Participants
Number of Participants With Clinically Significant Change From Baseline in Blood Pressure and Pulse Rate
ParticipantsPF-06372865 17.5 mgPF-06372865 52.5 mgLorazepam 2 mgPlacebo
Number of Participants With Clinically Significant Change From Baseline in Blood Pressure and Pulse Rate0000
SecondaryNumber of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings
Time frame:
17 weeks
Reported as:
Number · Participants
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings
ParticipantsPF-06372865 17.5 mgPF-06372865 52.5 mgLorazepam 2 mgPlacebo
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings0000
SecondaryNumber 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.

Time frame:
19 weeks
Reported as:
Number · Participants
Number of Participants With Treatment-emergent Adverse Events (AEs)
ParticipantsPF-06372865 17.5 mgPF-06372865 52.5 mgLorazepam 2 mgPlacebo
Treatment-emergent non serious AEs4665
Treatment-emergent serious AEs0000

Adverse events

Collected over 19 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo0/7 (0%)0/7 (0%)4/7 (57.1%)
PF-06372865 17.5 mg0/7 (0%)0/7 (0%)6/7 (85.7%)
PF-06372865 52.5 mg0/7 (0%)0/7 (0%)6/7 (85.7%)
Lorazepam 2 mg0/7 (0%)0/7 (0%)5/7 (71.4%)
Most frequent other events
Showing 10 of 23
Most frequent other events
EventPlaceboPF-06372865 17.5 mgPF-06372865 52.5 mgLorazepam 2 mg
SomnolenceNervous system disorders3/73/74/73/7
DizzinessNervous system disorders0/73/73/71/7
Vision blurredEye disorders0/70/71/70/7
Abdominal pain upperGastrointestinal disorders1/70/70/70/7
NauseaGastrointestinal disorders1/70/71/70/7
VomitingGastrointestinal disorders1/71/71/70/7
FatigueGeneral disorders0/70/70/71/7
Feeling hotGeneral disorders0/71/70/70/7
PainGeneral disorders0/70/71/70/7
PharyngitisInfections and infestations0/71/71/70/7

Baseline characteristics

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
Age, Continuous(years)All Participants
Mean27 ± 7.3
Sex: Female, Male
Sex: Female, Male(Participants)All Participants
Female5
Male2
Race (NIH/OMB)
Race (NIH/OMB)(Participants)All Participants
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American0
White7
More than one race0
Unknown or Not Reported0
08

Study locations

16 sites
  • Consultants in Epilepsy & Neurology, PLLC
    Boise, Idaho 83702, United States
  • Johns Hopkins University Department of Neurology
    Baltimore, Maryland 21287-7247, United States
  • Barnes Jewish Hospital
    Saint Louis, Missouri 63110, United States
  • Center for Advanced Medicine
    Saint Louis, Missouri 63110, United States
  • Washington University School of Medicine
    Saint 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
09

References and documents

Publications

  • 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. PubMed 30877186 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 14, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02564029
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Sep 30, 2015
Start date
Dec 16, 2015
Primary completion
Jan 10, 2017
Completion
Feb 7, 2017
Results posted
Mar 14, 2018
Last update
Mar 14, 2018

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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