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

Completed · Phase 2

Conditions studied: Narcolepsy

In brief

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.

Key facts

Study ID

NCT00424931

Run by

Alza Corporation, DE, USA

People needed

16

Starts

2007-01-01

Expected to finish

2007-12-01

Last updated by the study team

2014-05-23

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• diagnosis of narcolepsy within the past 5 years
• good general health
• no history or presence of drug or alcohol abuse

You may not qualify if…

• current use of prescription or over the counter medications including asprin or herbal supplements with the exception of acetaminophen (Tylenol)
• use of fluoxetine (Prozac) in the past 6 weeks
• use of Xyrem in the past 4 weeks
• use of tobacco products in the past 3 months
• caffeine consumption that is more than 5 cups of tea, or 3 cups of coffee or 8 cans of soda per day

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Phoenix, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — San Diego, California, United States
• Study site — Stanford, California, United States
• Study site — Spring Hill, Florida, United States
• Study site — St. Petersburg, Florida, United States
• Study site — Macon, Georgia, United States
• Study site — Danville, Indiana, United States
• Study site — Fort Wayne, Indiana, United States
• Study site — Amherst, New York, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Toledo, Ohio, United States
• Study site — Columbia, South Carolina, United States
• Study site — Houston, Texas, United States
• Study site — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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