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PF-06372865 in Subjects With Photosensitive Epilepsy

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ClinicalTrials.gov Identifier: NCT02564029
Recruitment Status : Completed
First Posted : September 30, 2015
Results First Posted : March 14, 2018
Last Update Posted : March 14, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
PF-06372865 in subjects with photosensitive epilepsy

Condition or disease Intervention/treatment Phase
Reflex Epilepsy, Photosensitive Drug: PF-06372865 Drug: Placebo Drug: Lorazepam Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: A Double Blind, Randomized, Cross- Over Study Examining Efficacy Of Pf-06372865 In A Photosensitivity Epilepsy Study Using Lorazepam As A Positive Control
Actual Study Start Date : December 16, 2015
Actual Primary Completion Date : January 10, 2017
Actual Study Completion Date : February 7, 2017


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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02564029


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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02564029     History of Changes
Other Study ID Numbers: B7431005
First Posted: September 30, 2015    Key Record Dates
Results First Posted: March 14, 2018
Last Update Posted: March 14, 2018
Last Verified: February 2018

Additional relevant MeSH terms:
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Epilepsy
Epilepsy, Reflex
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Lorazepam
Anticonvulsants
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hypnotics and Sedatives
Central Nervous System Depressants
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action