Overview

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