PF-06372865 in Subjects With Photosensitive Epilepsy
- Conditions
- Reflex Epilepsy, Photosensitive
- Interventions
- Registration Number
- NCT02564029
- Lead Sponsor
- Pfizer
- Brief Summary
PF-06372865 in subjects with photosensitive epilepsy
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 7
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description PF-06372865 dose level 2 PF-06372865 52.5 mg single dose Placebo Placebo Single dose PF-06372865 dose level 1 PF-06372865 17.5 milligram (mg) single dose Lorazepam Lorazepam 2mg single dose
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 Plasma Concentration of Lorazepam 1, 2, 3, 4 and 6 hours post-dose 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.
Maximum Plasma Concentration (Cmax) of PF-06372865 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 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.
Number of Participants With Clinically Significant Laboratory Test Abnormalities 17 weeks Safety laboratory tests included hematological, clinical chemistry (serum) and urinalysis safety tests.
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 Number of Participants With Treatment-emergent Adverse Events (AEs) 19 weeks 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.
Trial Locations
- Locations (16)
Consultants in Epilepsy & Neurology, PLLC
🇺🇸Boise, Idaho, United States
Hospital of the Univ of PA Pharmacy Service
🇺🇸Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital EEG lab
🇺🇸Philadelphia, Pennsylvania, United States
VU Department of Neurology
🇺🇸Nashville, Tennessee, United States
Vanderbilt University Epilepsy Clinic
🇺🇸Nashville, Tennessee, United States
Center for Advanced Medicine
🇺🇸Saint Louis, Missouri, United States
New York University Comprehensive Epilepsy Center
🇺🇸New York, New York, United States
Johns Hopkins University Department of Neurology
🇺🇸Baltimore, Maryland, United States
Barnes Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
Clinical and Translational Research Center
🇺🇸Philadelphia, Pennsylvania, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Thomas Jefferson University Investigational Drug Service
🇺🇸Philadelphia, Pennsylvania, United States
Thomas Jefferson University Comprehensive Epilepsy Center
🇺🇸Philadelphia, Pennsylvania, United States
General Clinical Research Center (GCRC)
🇺🇸Nashville, Tennessee, United States
Vanderbilt University Hospital Pharmacy
🇺🇸Nashville, Tennessee, United States