A Study of the Effects of JNJ-26489112 on the Photic Induced Paroxysmal Electroencephalogram (EEG) Response in Patients With Photosensitive Epilepsy
Condition: Photosensitive Epilepsy
MeSH terms: Epilepsy; Epilepsy, Reflex
Study type: Interventional
Phase: Phase 2

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 description: 
      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 complete suppression in at least 2 patients)
      in the first cohort, the dose level of JNJ-26489112 may be reduced in subsequent cohorts
      until the reduction or suppression of photosensitivity is seen in fewer than 2 out of 4
      patients in one cohort. Once an effective dose has been reached an additional open-label
      cohort may be enrolled in which no study drug (JNJ-26489112 or placebo) will be administered
      to patients. Study drug (i.e., JNJ-26489112 or placebo) will be administered orally as single
      doses on Days 1 to 3. Placebo will be administered on Days 1 and 3, and a single dose of
      JNJ-26489112 will be administered on Day 2.
    

Intervention name(s): JNJ-26489112; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single oral dose of JNJ-26489112 up to 3000 mg on Day 2.; Single dose of placebo on Day 1, and a second single dose of placebo on Day 3.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Photosensitive epilepsy; Reflex epilepsy; Epilepsy; JNJ-26489112