PF-06372865 in Subjects With Photosensitive Epilepsy
A Double Blind, Randomized, Cross- Over Study Examining Efficacy Of Pf-06372865 In A Photosensitivity Epilepsy Study Using Lorazepam As A Positive Control
1 other identifier
interventional
7
1 country
16
Brief Summary
PF-06372865 in subjects with photosensitive epilepsy
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Dec 2015
Shorter than P25 for phase_2
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 10, 2015
CompletedFirst Posted
Study publicly available on registry
September 30, 2015
CompletedStudy Start
First participant enrolled
December 16, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 10, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 7, 2017
CompletedResults Posted
Study results publicly available
March 14, 2018
CompletedMarch 14, 2018
February 1, 2018
1.1 years
September 10, 2015
December 21, 2017
February 16, 2018
Conditions
Outcome Measures
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.
Pre-dose, 1, 2, 4 and 6 hours post-dose
Secondary Outcomes (10)
The SPR in the Eye Closure, Eyes Closed, and Eyes Open Condition
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)
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
- +5 more secondary outcomes
Study Arms (4)
PF-06372865 dose level 1
EXPERIMENTAL17.5 milligram (mg) single dose
PF-06372865 dose level 2
EXPERIMENTAL52.5 mg single dose
Placebo
PLACEBO COMPARATORSingle dose
Lorazepam
ACTIVE COMPARATOR2mg single dose
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (16)
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
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
Related Publications (1)
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.
PMID: 30877186DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 10, 2015
First Posted
September 30, 2015
Study Start
December 16, 2015
Primary Completion
January 10, 2017
Study Completion
February 7, 2017
Last Updated
March 14, 2018
Results First Posted
March 14, 2018
Record last verified: 2018-02