Clinical Trial: PF-06372865 in Subjects With Photosensitive Epilepsy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: PF-06372865 in subjects with photosensitive epilepsy

Detailed Summary:
Sponsor: Pfizer

Current Primary Outcome: Efficacy of PF-06372865 to reduce photosensitive range in subjects with documented photoepilepsy in their most sensitive eye state [ Time Frame: 0, 1, 2, 4, 6 hours post-dose ]

The Standardized Photosensitivity Range (SPR) in the subject's most sensitive eye condition as measured by the Least Squares mean SPR averaged across all post-dose time points (up to 6 hours).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • To investigate the ability of PF-06372865 to demonstrate ant-convulsive efficacy for pre-specified secondary endpoints in subjects with documented photosensitive epilepsy [ Time Frame: 0, 1, 2, 4 and 6 hours post-dose ]
    The proportion of subjects with complete suppression, partial response, and no response to intermittent photic stimulation
  • To investigate the ability of PF-06372865 to demonstrate anti-convulsive efficacy for pre-specified secondary endpoints in subjects with documented photosensitive epilepsy [ Time Frame: 0, 1, 2, 4 and 6 hours post-dose ]
    The Standardized Photosensitivity Range (SPR) in the eyes closed, eye closure, and eyes open condition
  • Single dose maximum observed plasma concentration (Cmax) of PF-06372865 [ Time Frame: 0, 1, 2, 3, 4, and 6 hours post-dose ]
  • Single dose area under the curve from time zero to last quantifiable concentration [AUC (last)] of PF-06372865 [ Time Frame: 0, 1, 2, 3, 4 and 6 hours post-dose ]
  • Single dose time to reach maximum observed plasma concentration (Tmax) of PF-06372865 [ Time Frame: 0, 1, 2, 3, 4 and 6 hours post-dose ]
  • Single dose plasma concentration of lorazepam [ Time Frame: 0, 1, 2, 3, 4, and 6 hours post-dose ]


Original Secondary Outcome: Same as current

Information By: Pfizer

Dates:
Date Received: September 10, 2015
Date Started: December 16, 2015
Date Completion:
Last Updated: April 17, 2017
Last Verified: April 2017