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

Completed · Phase 2 · Has a placebo group

Conditions studied: Narcolepsy

In brief

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.

Key facts

Study ID

NCT01485770

Run by

Jazz Pharmaceuticals

People needed

33

Starts

2011-12-01

Expected to finish

2012-05-01

Last updated by the study team

2021-07-06

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of narcolepsy
• Good general health
• Willing and able to comply with the study design and schedule and other requirements

You may not qualify if…

• 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

Where it is running

• Pulmonary Associates — Phoenix, Arizona, United States
• Clinical Research Group of St. Petersburg — St. Petersburg, Florida, United States
• Neurotrials Research, Inc. — Atlanta, Georgia, United States
• Sleep Disorders Center of Georgia — Atlanta, Georgia, United States
• SleepMed of Central Georgia — Macon, Georgia, United States
• The Center for Sleep and Wake Disorders — Chevy Chase, Maryland, United States
• Mercy St. Anne Sleep Disorders Center — Toledo, Ohio, United States
• SleepMed of South Carolina — Columbia, South Carolina, United States
• Future Search Trials of Neurology — Austin, Texas, United States
• Sleep Medicine Associates of Texas — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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