A Study of the Safety and Effectiveness of ADX-N05 in the Treatment of Excessive Daytime Sleepiness

• Status: Completed
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jazz Pharmaceuticals

Criteria

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 two years

• Nicotine dependence that has an affect on sleep