PF-06372865 in Subjects With Photosensitive Epilepsy

Phase 2CompletedNCT02564029

Pfizer7 enrolled

Overview

PF-06372865 in subjects with photosensitive epilepsy

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Reflex Epilepsy, Photosensitive

Interventions

PF-06372865DRUG

Single dose

PlaceboDRUG

Placebo for PF-06372865 and placebo for lorazepam

LorazepamDRUG

2 mg single oral dose

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Locations (16)

Consultants in Epilepsy & Neurology, PLLC

Boise, Idaho, United States

Johns Hopkins University Department of Neurology

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

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

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

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

Maximum Plasma Concentration (Cmax) of PF-06372865

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

Data from ClinicalTrials.gov

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