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PF-06372865 in Subjects With Photosensitive Epilepsy

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NCT02564029

Last updated on March 22, 2018
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FOR MORE INFORMATION
Study Location
Consultants in Epilepsy & Neurology, PLLC
Boise, Idaho, 83702 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Photosensitive Reflex Epilepsy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-60 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT02564029
Pfizer
Completed
PF-06372865 in Subjects With Photosensitive Epilepsy

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PF-06372865 in Subjects With Photosensitive Epilepsy
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
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Reflex Epilepsy, Photosensitive
  • Drug: PF-06372865
    Single dose
  • Drug: Placebo
    Placebo for PF-06372865 and placebo for lorazepam
  • Drug: Lorazepam
    2 mg single oral dose
  • Experimental: PF-06372865 dose level 1
    17.5 milligram (mg) single dose
    Intervention: Drug: PF-06372865
  • Experimental: PF-06372865 dose level 2
    52.5 mg single dose
    Intervention: Drug: PF-06372865
  • Placebo Comparator: Placebo
    Single dose
    Intervention: Drug: Placebo
  • Active Comparator: Lorazepam
    2mg single dose
    Intervention: Drug: Lorazepam
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
7
February 7, 2017
January 10, 2017   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02564029
B7431005
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]



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