A Study of the Safety and Effectiveness of ADX-N05 for Excessive Daytime Sleepiness in Subjects With Narcolepsy


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Trial ID: NCT01681121


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
Clete A. Kushida, MD, PhD

Professor of Psychiatry and Behavioral Sciences (Sleep Medicine)


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


drug: ADX-N05

drug: Placebo


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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Paul Stowers