Status:
COMPLETED
A Safety and Effectiveness Study of a Single Dose of JNJ-17216498 in Patients With Narcolepsy
Lead Sponsor:
Alza Corporation, DE, USA
Conditions:
Narcolepsy
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
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 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 w...
Eligibility Criteria
Inclusion
- diagnosis of narcolepsy within the past 5 years
- good general health
- no history or presence of drug or alcohol abuse
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00424931
Start Date
January 1 2007
End Date
December 1 2007
Last Update
May 23 2014
Active Locations (16)
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1
Birmingham, Alabama, United States
2
Phoenix, Arizona, United States
3
Tucson, Arizona, United States
4
San Diego, California, United States