A Study of the Safety and Effectiveness of ADX-N05 for Excessive Daytime Sleepiness in Subjects With Narcolepsy
Trial ID or NCT#
Status
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
Eligibility Criteria
- * 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
Investigator(s)
Contact us to find out if this trial is right for you.
Contact
Paul Stowers
650-721-7551
View on ClinicalTrials.gov