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

Trial ID or NCT#

NCT01681121

Status

recruiting iconRECRUITING

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:
  1. - Diagnosis of narcolepsy - Good general health - Willing and able to comply with the study design and schedule and other requirements
Exclusion Criteria:
  1. - 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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Investigator(s)

Clete A. Kushida, MD, PhD
Clete A. Kushida, MD, PhD
Sleep specialist, Neurologist
Professor of Psychiatry and Behavioral Sciences (Sleep Medicine)

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Contact

Paul Stowers
650-721-7551

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View on ClinicalTrials.gov