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JNJ-26489112

Phase 2

Photosensitive Epilepsy | Small molecule | Neurology |Johnson & Johnson|Last Updated: Apr 5, 2012

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment12
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00579384A Study of the Effects of JNJ-26489112 on the Photic Induced Paroxysmal Electroencephalogram (EEG) Response in Patients With Photosensitive EpilepsyPHASE2 COMPLETED 12Oct 1, 2007Jul 1, 2008Apr 5, 2012 -
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Study Endpoints
Primary Endpoints
The photosensitivity range in each eye condition (during closure, closed, open) based upon the photoparoxysmal electroencepholgram (EEG) response to intermittent photic stimulation (IPS).
Hours 1 to 8 (Day 2) and 25 to 33 postdose (Day 3) with optional assessments at 48, 52, and 56 hours postdose
Secondary Endpoints
The safety, tolerability, pharmacokinetics and pharmacokinetic/pharmacodynamic relationship of JNJ-26489112.
Day 1 to Day 3 and an optional Day 4
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingSINGLE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
001EXPERIMENTAL -
Interventions
NameTypeDescription
JNJ-26489112DRUGSingle oral dose of JNJ-26489112 up to 3000 mg on Day 2.
PlaceboDRUGSingle dose of placebo on Day 1, and a second single dose of placebo on Day 3.
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersNo

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-men...

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