Status:
COMPLETED
A Study of the Safety and Effectiveness of ADX-N05 in the Treatment of Excessive Daytime Sleepiness
Lead Sponsor:
Jazz Pharmaceuticals
Conditions:
Narcolepsy
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- Diagnosis of narcolepsy
- Good general health
- Willing and able to comply with the study design and schedule and other requirements
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT01485770
Start Date
December 1 2011
End Date
May 1 2012
Last Update
July 6 2021
Active Locations (10)
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1
Pulmonary Associates
Phoenix, Arizona, United States, 85006
2
Clinical Research Group of St. Petersburg
St. Petersburg, Florida, United States, 33707
3
Neurotrials Research, Inc.
Atlanta, Georgia, United States, 30342
4
Sleep Disorders Center of Georgia
Atlanta, Georgia, United States, 30342