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Completed

NCT Number: NCT02564029

PF-06372865 in Subjects With Photosensitive Epilepsy

PF-06372865 in subjects with photosensitive epilepsy

Completed

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Key information

Conditions

Reflex Epilepsy, Photosensitive Brain Diseases Central Nervous System Diseases Epilepsy Epilepsy, Reflex Nervous System Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Consultants in Epilepsy & Neurology, PLLC, Boise, Idaho, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PF-06372865

Drug

Single dose

Placebo

Drug

Placebo for PF-06372865 and placebo for lorazepam

Lorazepam

Drug

2 mg single oral dose

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. Maximum Plasma Concentration (Cmax) of PF-06372865

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

  4. 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

  5. Time for Cmax (Tmax) of PF-06372865

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

  6. Plasma Concentration of Lorazepam

    Time frame: 1, 2, 3, 4 and 6 hours post-dose

  7. 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.

  8. Number of Participants With Clinically Significant Change From Baseline in Blood Pressure and Pulse Rate

    Time frame: 17 weeks

  9. Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings

    Time frame: 17 weeks

  10. 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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Sep 30, 2015
Registry last updated
Mar 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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