PF-06372865 in Subjects With Photosensitive Epilepsy

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NCT02564029

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Study Location
Consultants in Epilepsy & Neurology, PLLC
Boise, Idaho, 83702, United States
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Contact
1-800-718-1021
[email protected]
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1-800-718-1021

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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.

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Photosensitive Reflex EpilepsyPF-06372865 in Subjects With Photosensitive Epilepsy
NCT02564029
  1. Boise, Idaho
  2. Baltimore, Maryland
  3. Saint Louis, Missouri
  4. Saint Louis, Missouri
  5. Saint Louis, Missouri
  6. New York, New York
  7. Philadelphia, Pennsylvania
  8. Philadelphia, Pennsylvania
  9. Philadelphia, Pennsylvania
  10. Philadelphia, Pennsylvania
  11. Philadelphia, Pennsylvania
  12. Philadelphia, Pennsylvania
  13. Nashville, Tennessee
  14. Nashville, Tennessee
  15. Nashville, Tennessee
  16. Nashville, Tennessee
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE PF-06372865 in Subjects With Photosensitive Epilepsy
Official Title  ICMJE A Double Blind, Randomized, Cross- Over Study Examining Efficacy Of Pf-06372865 In A Photosensitivity Epilepsy Study Using Lorazepam As A Positive Control
Brief Summary PF-06372865 in subjects with photosensitive epilepsy
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Reflex Epilepsy, Photosensitive
Intervention  ICMJE
  • Drug: PF-06372865
    Single dose
  • Drug: Placebo
    Placebo for PF-06372865 and placebo for lorazepam
  • Drug: Lorazepam
    2 mg single oral dose
Study Arms  ICMJE
  • 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
Publications * Gurrell R, Gorman D, Whitlock M, Ogden A, Reynolds DS, DiVentura B, Abou-Khalil B, Gelfand M, Pollard J, Hogan RE, Krauss G, Sperling M, Vazquez B, Wechsler RT, Friedman D, Butt RP, French J. Photosensitive epilepsy: Robust clinical efficacy of a selective GABA potentiator. Neurology. 2019 Apr 9;92(15):e1786-e1795. doi: 10.1212/WNL.0000000000007271. Epub 2019 Mar 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 13, 2017)		7
Original Estimated Enrollment  ICMJE
 (submitted: September 28, 2015)		8
Actual Study Completion Date  ICMJE February 7, 2017
Actual Primary Completion Date January 10, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02564029
Other Study ID Numbers  ICMJE B7431005
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP