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 iconNOT 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: Yes
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)

Contact us to find out if this trial is right for you.

Contact

Paul Stowers
650-721-7551

View on ClinicalTrials.gov