A Safety and Effectiveness Study of a Single Dose of JNJ-17216498 in Patients With Narcolepsy
Condition: Narcolepsy
MeSH terms: Narcolepsy
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and effectiveness of JNJ-17216498
      compared to modafinil and placebo in patients with narcolepsy, with and without cataplexy.
    

Detailed description: 
      This study with a new, experimental drug is being done to assess safety and tolerability, and
      to explore effectiveness in the treatment of narcolepsy. Approximately 64 adult patients with
      narcolepsy with or without cataplexy will be recruited for the study. Patients who meet study
      criteria will need to stop taking their current narcolepsy and/ or other medication for at
      least 14 days before checking into the site for 3 nights. They will be randomly assigned to
      one of 4 treatment arms; each patient has an equal chance of receiving placebo, 10 mg
      JNJ-17216498, 50 mg JNJ-17216498 or 400 mg modafinil. Placebo has no active drug. Modafinil
      is a drug currently approved to treat narcolepsy. Patients will take the medication on only
      one day and will receive study medication in a blinded fashion, i.e. the patient, the doctor
      and the study sponsor will not know what group the patient is in until all patients complete
      the study. The investigator and the sponsor will monitor the study for the occurrence of
      possible side effects. In addition to a screening visit and the three nights at the site,
      there will be a follow-up visit 7-10 days after the day the study drug is taken. After the
      follow-up visit, patients may resume their previous narcolepsy medications. Medical history,
      physical examination, vision tests, blood pressure, heart rate, temperature, and ECGs will be
      checked periodically. Blood samples will be taken for standard safety laboratory tests as
      well as for the measurement of the drug blood level. The Maintenance of Wakefulness Test will
      be done to assess the patient's ability to resist falling asleep while reclining in a dark,
      quiet room; this will involve completing 7 sessions before dosing and 10 sessions after
      dosing. Patients will have two polysomnograms, a test of brain, muscle and eye activity
      during sleep, obtained by recording brain waves and other activities such as muscle and eye
      movement. Polysomnograms will be obtained overnight, once before and once after dosing.
      Patients will also complete brief questionnaires about their sleepiness and the status of
      their narcolepsy throughout the study. Patients will receive capsules containing either 10 mg
      JNJ-17216498, 50 mg JNJ-17216498, 400 mg modafinil and/or placebo on one day. Seven capsules
      will be taken orally in the morning and two capsules will be taken orally in the afternoon.
      Placebo contains no active drug. Modafinil is a drug currently approved to treat narcolepsy.
    

Intervention name(s): JNJ-17216498; JNJ-17216498; Modafinil
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 50mg one time; 10mg one time; 200 mg X 2
Intervention MeSH terms: Modafinil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: narcolepsy; sleepiness