Clinical Trial: A Safety and Effectiveness Study of a Single Dose of JNJ-17216498 in Patients With Narcolepsy

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

Official Title: A Phase II Randomized, Double-blind, Double-dummy, Placebo and Comparator-controlled, Parallel Group, Multi-Center Study to Investigate the Safety and Efficacy of a Single Dose of JNJ-17216498 Adminis

Brief 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 Summary: 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 afte
Sponsor: Alza Corporation, DE, USA

Current Primary Outcome: Explore the effectiveness of JNJ-17216498 in patients with narcolepsy as determined by the Maintenance of Wakefulness Test done throughout the study. [ Time Frame: ·To explore efficacy of JNJ-17216498 in patients with narcolepsy with or without cataplexy up through 48 hours after dosing. ]

Original Primary Outcome: Explore the effectiveness of JNJ-17216498 in patients with narcolepsy as determined by the Maintenance of Wakefulness Test done throughout the study.

Current Secondary Outcome: Explore the safety and tolerability of JNJ-17216498 in patients with narcolepsy by assessing adverse events, vital signs, laboratory results, vision tests, physical exam and ECGs. [ Time Frame: To explore the safety and tolerability of JNJ-17216498 in patients with narcolepsy with or without cataplexy throughout the study. ]

Original Secondary Outcome: Explore the safety and tolerability of JNJ-17216498 in patients with narcolepsy by assessing adverse events, vital signs, laboratory results, vision tests, physical exam and ECGs.

Information By: Alza Corporation, DE, USA

Dates:
Date Received: January 19, 2007
Date Started: January 2007
Date Completion:
Last Updated: May 21, 2014
Last Verified: May 2014