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A Study of the Safety and Effectiveness of ADX-N05 for Excessive Daytime Sleepiness in Subjects With Narcolepsy
Trial ID or NCT#
NCT01681121
Status
NOT RECRUITING
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
Ages Eligible for Study: 18 Years to 70 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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
Investigator(s)
Clete A. Kushida, MD, PhD
Sleep specialist,
Neurologist
Professor of Psychiatry and Behavioral Sciences at the Stanford University Medical Center
Contact us to find out if this trial is right for you.
CONTACT
Paul Stowers
(650) 721-7551
View on ClinicalTrials.gov
About this Clinical Trial
Your Message Will Go To
Paul Stowers650-721-7551