A Study of the Effects of JNJ-26489112 on the Photic Induced Paroxysmal Electroencephalogram (EEG… (NCT00579384) | Clinical Trial Compass
CompletedPhase 2
A Study of the Effects of JNJ-26489112 on the Photic Induced Paroxysmal Electroencephalogram (EEG) Response in Patients With Photosensitive Epilepsy
12 participantsStarted 2007-10
Plain-language 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.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion Criteria:
* Males or postmenopausal/surgically sterile females. Post-menopausal is defined as no menses for the 18 months prior to study start. If menses have ceased within 36 months of the start of this study, then plasma follicle stimulating hormone must be elevated to within a post-menopausal range at study screening
* Pre-menopausal surgically sterilized patients must have a negative beta chorionic gonadotropin pregnancy test at screening and at Day -2
* Women of childbearing potential may be enrolled when results of the reproductive toxicology studies become available, after review of that reproductive toxicology data and upon agreement of the Sponsor and Principal Investigator and the relevant local Ethics Committee, provided these women agree to utilize an acceptable method of birth control
* Body Mass Index (BMI) between 18.5 and 35 kg/m2 (inclusive)
* BMI= weight/height2
* Firm documented diagnosis of idiopathic, photosensitive epilepsy with a generalized photoparoxysmal EEG response
* A photosensitive range in response to intermittent photic stimulation equal to or greater than 4 points in at least one eye condition at screening
* All values for hematology, coagulation, chemistry, and urinalysis within clinically acceptable ranges as they would be for healthy subjects prior to administration of study drug
* Willing to adhere to the prohibitions and restrictions specified in this protocol
* Male patients who are not sterile and are unwilling to use condoms…
What they're measuring
1
The photosensitivity range in each eye condition (during closure, closed, open) based upon the photoparoxysmal electroencepholgram (EEG) response to intermittent photic stimulation (IPS).
Timeframe: Hours 1 to 8 (Day 2) and 25 to 33 postdose (Day 3) with optional assessments at 48, 52, and 56 hours postdose
Trial details
NCT IDNCT00579384
SponsorJohnson & Johnson Pharmaceutical Research & Development, L.L.C.