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A Study of the Safety and Effectiveness of ADX-N05 for Excessive Daytime Sleepiness in Subjects With Narcolepsy
Not Recruiting
Trial ID: NCT01681121
Purpose
This is a study to evaluate the safety and effectiveness of ADX-N05 compared to placebo in the treatment of excessive daytime sleepiness in adults with narcolepsy.
Official Title
A Twelve-week, Double-blind, Placebo-controlled, Randomized, Parallel-group, Multi-center Study of the Safety and Efficacy of ADX-N05 in the Treatment of Excessive Daytime Sleepiness in Subjects With Narcolepsy
Stanford Investigator(s)
Clete A. Kushida, MD, PhD
Professor of Psychiatry and Behavioral Sciences (Sleep Medicine)
Eligibility
Inclusion Criteria:
* Diagnosis of narcolepsy
* Good general health
* Willing and able to comply with the study design and schedule and other requirements
Exclusion Criteria:
* If female, pregnant or lactating
* Customary bedtime later than midnight
* History of significant medical condition, behavioral, or psychiatric disorder (including suicidal ideation), or surgical history
* Any other clinically relevant medical, behavioral or psychiatric disorder other than narcolepsy that is associated with excessive sleepiness
* History of significant cardiovascular disease
* Body mass index \> 34
* Excessive caffeine use - \> 600 mg/day of caffeine or \> 6 cups of coffee/day
* History of alcohol or drug abuse within the past 2 years
* Nicotine dependence that has an effect on sleep
Intervention(s):
drug: ADX-N05
drug: Placebo
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Paul Stowers
650-721-7551