PF-06372865 in Subjects With Photosensitive Epilepsy

February 16, 2018 updated by: Pfizer

A Double Blind, Randomized, Cross- Over Study Examining Efficacy Of Pf-06372865 In A Photosensitivity Epilepsy Study Using Lorazepam As A Positive Control

PF-06372865 in subjects with photosensitive epilepsy

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Idaho
      • Boise, Idaho, United States, 83702
        • Consultants in Epilepsy & Neurology, PLLC
    • Maryland
      • Baltimore, Maryland, United States, 21287-7247
        • Johns Hopkins University Department of Neurology
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
      • Saint Louis, Missouri, United States, 63110
        • Barnes Jewish Hospital
      • Saint Louis, Missouri, United States, 63110
        • Center for Advanced Medicine
    • New York
      • New York, New York, United States, 10016
        • New York University Comprehensive Epilepsy Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Comprehensive Epilepsy Center
      • Philadelphia, Pennsylvania, United States, 19104
        • Clinical and Translational Research Center
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the Univ of PA Pharmacy Service
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital EEG lab
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Investigational Drug Service
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Hospital Pharmacy
      • Nashville, Tennessee, United States, 37232
        • VU Department of Neurology
      • Nashville, Tennessee, United States, 37232
        • General Clinical Research Center (GCRC)
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Epilepsy Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PF-06372865 dose level 1
17.5 milligram (mg) single dose
Drug: PF-06372865
Single dose
Experimental: PF-06372865 dose level 2
52.5 mg single dose
Drug: PF-06372865
Single dose
Placebo Comparator: Placebo
Single dose
Drug: Placebo
Placebo for PF-06372865 and placebo for lorazepam
Active Comparator: Lorazepam
2mg single dose
Drug: Lorazepam
2 mg single oral dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Standardized Photosensitivity Range (SPR) in the Subject's Most Sensitive Eye Condition
Time Frame: 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.
Pre-dose, 1, 2, 4 and 6 hours post-dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The SPR in the Eye Closure, Eyes Closed, and Eyes Open Condition
Time Frame: 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.
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)
Time Frame: 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.
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
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
Time Frame: Pre-dose, 1, 2, 3, 4 and 6 hours post-dose
Pre-dose, 1, 2, 3, 4 and 6 hours post-dose
Time for Cmax (Tmax) of PF-06372865
Time Frame: 1, 2, 4 and 6 hours post-dose
1, 2, 4 and 6 hours post-dose
Plasma Concentration of Lorazepam
Time Frame: 1, 2, 3, 4 and 6 hours post-dose
1, 2, 3, 4 and 6 hours post-dose
Number of Participants With Clinically Significant Laboratory Test Abnormalities
Time Frame: 17 weeks
Safety laboratory tests included hematological, clinical chemistry (serum) and urinalysis safety tests.
17 weeks
Number of Participants With Clinically Significant Change From Baseline in Blood Pressure and Pulse Rate
Time Frame: 17 weeks
17 weeks
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings
Time Frame: 17 weeks
17 weeks
Number of Participants With Treatment-emergent Adverse Events (AEs)
Time Frame: 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.
19 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 16, 2015

Primary Completion (Actual)

January 10, 2017

Study Completion (Actual)

February 7, 2017

Study Registration Dates

First Submitted

September 10, 2015

First Submitted That Met QC Criteria

September 28, 2015

First Posted (Estimate)

September 30, 2015

Study Record Updates

Last Update Posted (Actual)

March 14, 2018

Last Update Submitted That Met QC Criteria

February 16, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B7431005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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