A Study of the Safety and Effectiveness of ADX-N05 for Excessive Daytime Sleepiness in Subjects With Narcolepsy
Trial ID or NCT#
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.
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
- - Diagnosis of narcolepsy - Good general health - Willing and able to comply with the study design and schedule and other requirements
- - 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
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