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PF-06372865 in Subjects With Photosensitive Epilepsy

Primary Purpose

Reflex Epilepsy, Photosensitive

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PF-06372865
Placebo
Lorazepam
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Reflex Epilepsy, Photosensitive

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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:

  • 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.

Sites / Locations

  • Consultants in Epilepsy & Neurology, PLLC
  • Johns Hopkins University Department of Neurology
  • Barnes Jewish Hospital
  • Center for Advanced Medicine
  • Washington University School of Medicine
  • New York University Comprehensive Epilepsy Center
  • Clinical and Translational Research Center
  • Hospital of the Univ of PA Pharmacy Service
  • University of Pennsylvania
  • Thomas Jefferson University Comprehensive Epilepsy Center
  • Thomas Jefferson University Hospital EEG lab
  • Thomas Jefferson University Investigational Drug Service
  • General Clinical Research Center (GCRC)
  • Vanderbilt University Epilepsy Clinic
  • Vanderbilt University Hospital Pharmacy
  • VU Department of Neurology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Placebo Comparator

Active Comparator

Arm Label

PF-06372865 dose level 1

PF-06372865 dose level 2

Placebo

Lorazepam

Arm Description

17.5 milligram (mg) single dose

52.5 mg single dose

Single dose

2mg single dose

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Maximum Plasma Concentration (Cmax) of PF-06372865
Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-06372865
Time for Cmax (Tmax) of PF-06372865
Plasma Concentration of Lorazepam
Number of Participants With Clinically Significant Laboratory Test Abnormalities
Safety laboratory tests included hematological, clinical chemistry (serum) and urinalysis safety tests.
Number of Participants With Clinically Significant Change From Baseline in Blood Pressure and Pulse Rate
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings
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.

Full Information

First Posted
September 10, 2015
Last Updated
February 16, 2018
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT02564029
Brief Title
PF-06372865 in Subjects With Photosensitive Epilepsy
Official Title
A Double Blind, Randomized, Cross- Over Study Examining Efficacy Of Pf-06372865 In A Photosensitivity Epilepsy Study Using Lorazepam As A Positive Control
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
December 16, 2015 (Actual)
Primary Completion Date
January 10, 2017 (Actual)
Study Completion Date
February 7, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
PF-06372865 in subjects with photosensitive epilepsy

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Reflex Epilepsy, Photosensitive

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PF-06372865 dose level 1
Arm Type
Experimental
Arm Description
17.5 milligram (mg) single dose
Arm Title
PF-06372865 dose level 2
Arm Type
Experimental
Arm Description
52.5 mg single dose
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Single dose
Arm Title
Lorazepam
Arm Type
Active Comparator
Arm Description
2mg single dose
Intervention Type
Drug
Intervention Name(s)
PF-06372865
Intervention Description
Single dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo for PF-06372865 and placebo for lorazepam
Intervention Type
Drug
Intervention Name(s)
Lorazepam
Intervention Description
2 mg single oral dose
Primary Outcome Measure Information:
Title
The Standardized Photosensitivity Range (SPR) in the Subject's Most Sensitive Eye Condition
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
Secondary Outcome Measure Information:
Title
The SPR in the Eye Closure, Eyes Closed, and Eyes Open Condition
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
Title
The Percentage of Participants With Complete Suppression, Partial Response, and no Response to Intermittent Photic Stimulation (IPS)
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
Title
Maximum Plasma Concentration (Cmax) of PF-06372865
Time Frame
1, 2, 4 and 6 hours post-dose
Title
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
Title
Time for Cmax (Tmax) of PF-06372865
Time Frame
1, 2, 4 and 6 hours post-dose
Title
Plasma Concentration of Lorazepam
Time Frame
1, 2, 3, 4 and 6 hours post-dose
Title
Number of Participants With Clinically Significant Laboratory Test Abnormalities
Description
Safety laboratory tests included hematological, clinical chemistry (serum) and urinalysis safety tests.
Time Frame
17 weeks
Title
Number of Participants With Clinically Significant Change From Baseline in Blood Pressure and Pulse Rate
Time Frame
17 weeks
Title
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings
Time Frame
17 weeks
Title
Number of Participants With Treatment-emergent Adverse Events (AEs)
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Consultants in Epilepsy & Neurology, PLLC
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
Facility Name
Johns Hopkins University Department of Neurology
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287-7247
Country
United States
Facility Name
Barnes Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Center for Advanced Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
New York University Comprehensive Epilepsy Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Clinical and Translational Research Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Hospital of the Univ of PA Pharmacy Service
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Thomas Jefferson University Comprehensive Epilepsy Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Thomas Jefferson University Hospital EEG lab
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Thomas Jefferson University Investigational Drug Service
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
General Clinical Research Center (GCRC)
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Vanderbilt University Epilepsy Clinic
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Vanderbilt University Hospital Pharmacy
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
VU Department of Neurology
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30877186
Citation
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7431005&StudyName=A%20Double%20Blind%2C%20Randomized%2C%20Cross-%20Over%20Study%20Examining%20Efficacy%20Of%20Pf-06372865%20In%20A%20Photosensitivity%20Epilepsy%20Study%20Using%20Lorazepam%20As%20A%20Positive%20Control
Description
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PF-06372865 in Subjects With Photosensitive Epilepsy

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