Clinical Trial: A Study to Investigate the Effect of ICA-105665 in Photosensitive Epilepsy Patients
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: A Phase 2, Multi-Center, Single-Blind, Placebo-Controlled Pharmacodynamic Evaluation of ICA-105665 in Epilepsy Patients With a Photo-Induced Paroxysmal EEG Response
Brief Summary: Subjects with epilepsy with a documented photoparoxysmal response to intermittent photic stimulation (IPS) will participate. Four subjects will be enrolled at each dose level and will receive a single dose of placebo and a single dose of ICA-105665 during the study, each followed by intermittent photic stimulation. The effects of ICA-105665 on the photoparoxysmal electroencephalography (EEG) response of each group will be reviewed before the dose is selected for each subsequent group of subjects.
Detailed Summary:
Sponsor: Pfizer
Current Primary Outcome: Change in photosensitivity response [ Time Frame: begin 1 hr post dose for 8 hours ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- To correlate plasma concentrations of ICA-105665 with effect on the frequency range of IPS-induced PPR (Photoparoxysmal response) in subjects with photosensitive epilepsy. [ Time Frame: 3 days ]
- To assess the safety of a single dose of ICA-105665 in subjects with photosensitive epilepsy. [ Time Frame: 30 days ]
Original Secondary Outcome:
- To correlate plasma concentrations of ICA-105665 with effect on the frequency range of IPS-induced PPR in subjects with photosensitive epilepsy. [ Time Frame: 3 days ]
- To assess the safety of a single dose of ICA-105665 in subjects with photosensitive epilepsy. [ Time Frame: 30 days ]
Information By: Pfizer
Dates:
Date Received: September 16, 2009
Date Started: September 2009
Date Completion:
Last Updated: September 27, 2012
Last Verified: September 2012
