Clinical Trial: A Study of the Effects of JNJ-26489112 on the Photic Induced Paroxysmal Electroencephalogram (EEG) Response in Patients With Photosensitive Epilepsy

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

Official Title: A Study of the Effects of JNJ-26489112 on the Photic Induced Paroxysmal Electroencephalogram Response in Patients With Photosensitive Epilepsy

Brief Summary: The purpose of this study is to check the Effects of JNJ-26489112 on the Photic Induced Paroxysmal electroencephalogram (EEG) Response in Patients with Photosensitive Epilepsy.

Detailed Summary:

This is a multicenter, non-randomized (participants are assigned deliberately), single-blind (patients do not know which treatment they are receiving), within patient placebo-controlled study. Up to 32 male or female patients will participate in this study. The duration of subject participation is approximately 6 weeks.

Patients will receive the oral doses of study drug in the mornings of Days 1, 2, and 3. All patients will receive a single dose of placebo on Day 1, a single dose of JNJ-26489112 on Day 2, and a second single dose of placebo on Day 3. Blood samples will be taken for evaluation of JNJ-26489112 drug concentrations in plasma and blood. Blood samples will also be collected for laboratory safety assessments and measurement of antiepileptic drug concentrations. Further safety will be assessed by the reporting of adverse events, vital signs, 12-lead ECG, physical and neurological examinations. Patients will be discharged on the evening of Day 3 after the pharmacokinetic samples have been collected, and after assessment by the investigator, unless there are any ongoing adverse events which require in-house monitoring. EEG tracings, recorded during intermittent photic stimulation sessions, will be digitally recorded on a CD-ROM, coded and evaluated independently by one blinded clinical expert to determine the effects on the photosensitivity range. If complete suppression of photosensitivity or reduction of the photosensitivity range by at least 3 points on the photosensitivity scale in at least one eye condition (during closure, closed, open) is not observed in at least 3 of the 4 patients and a maximum tolerated dose has been reached, the study will be stopped. If reduction of the photosensitivity range by at least 3 points on the photosensitivity scale in at least one eye condition (during closure, closed, open) is observed in at least 3 of the 4 patients (with c
Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Current Primary Outcome: The photosensitivity range in each eye condition (during closure, closed, open) based upon the photoparoxysmal electroencepholgram (EEG) response to intermittent photic stimulation (IPS). [ Time Frame: Hours 1 to 8 (Day 2) and 25 to 33 postdose (Day 3) with optional assessments at 48, 52, and 56 hours postdose ]

Original Primary Outcome: The photosensitivity range in each eye condition (during closure, closed, open) based upon the photoparoxysmal electroencepholgram (EEG) response to intermittent photic stimulation (IPS).

Current Secondary Outcome: The safety, tolerability, pharmacokinetics and pharmacokinetic/pharmacodynamic relationship of JNJ-26489112. [ Time Frame: Day 1 to Day 3 and an optional Day 4 ]

Original Secondary Outcome: The safety, tolerability, pharmacokinetics and pharmacokinetic/pharmacodynamic relationship of JNJ-26489112.

Information By: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Dates:
Date Received: December 20, 2007
Date Started: October 2007
Date Completion:
Last Updated: April 3, 2012
Last Verified: April 2012