PF-06372865 in Subjects With Photosensitive Epilepsy

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-16

Study Completion Date

2017-02-07

Brief Summary

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PF-06372865 in subjects with photosensitive epilepsy

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Detailed Description

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Conditions

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Reflex Epilepsy, Photosensitive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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PF-06372865 dose level 1

17.5 milligram (mg) single dose

Group Type EXPERIMENTAL

PF-06372865

Intervention Type DRUG

Single dose

PF-06372865 dose level 2

52.5 mg single dose

Group Type EXPERIMENTAL

PF-06372865

Intervention Type DRUG

Single dose

Placebo

Single dose

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo for PF-06372865 and placebo for lorazepam

Lorazepam

2mg single dose

Group Type ACTIVE_COMPARATOR

Lorazepam

Intervention Type DRUG

2 mg single oral dose

Interventions

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PF-06372865

Single dose

Intervention Type DRUG

Placebo

Placebo for PF-06372865 and placebo for lorazepam

Intervention Type DRUG

Lorazepam

2 mg single oral dose

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Consultants in Epilepsy & Neurology, PLLC

Boise, Idaho, United States

Site Status

Johns Hopkins University Department of Neurology

Baltimore, Maryland, United States

Site Status

Barnes Jewish Hospital

St Louis, Missouri, United States

Site Status

Center for Advanced Medicine

St Louis, Missouri, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status