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

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alza Corporation, DE, USA
• Treatments: Armodafinil; Modafinil

Criteria

Inclusion Criteria:

• diagnosis of narcolepsy within the past 5 years

• good general health

• no history or presence of drug or alcohol abuse

Exclusion Criteria:

• 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