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 ]
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