A Study of the Safety and Effectiveness of ADX-N05 for Excessive Daytime Sleepiness in Subjects With Narcolepsy

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

NCT01681121

Run by

Jazz Pharmaceuticals

People needed

93

Starts

2012-09-01

Expected to finish

2013-08-01

Last updated by the study team

2021-05-28

Who can join

Age: 18 and older, up to 70. 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 2 years
• Nicotine dependence that has an effect on sleep

Where it is running

• Sleep Disorders Center of Alabama — Birmingham, Alabama, United States
• Pulmonary Associates — Phoenix, Arizona, United States
• Stanford Sleep Medicine Center — Redwood City, California, United States
• Pacific Research Network — San Diego, California, United States
• Sleep-Alertness Disorders Center — Aurora, Colorado, United States
• PAB Clinical Research — Brandon, Florida, 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
• Chicago Research Center — Chicago, Illinois, United States
• Community Research — Crestview Hills, Kentucky, United States
• Kentucky Research Group — Louisville, Kentucky, United States
• The Center for Sleep and Wake Disorders — Chevy Chase, Maryland, United States
• Pulmonary and Critical Care Associates of Baltimore — Towson, Maryland, United States
• Neurocare, Inc. — Newton, Massachusetts, United States
• Minnesota Lung Center and Sleep Institute — Edina, Minnesota, United States
• Washington University — St Louis, Missouri, United States
• Rex Sleep Disorders Center — Raleigh, North Carolina, United States
• Wake Research Associates — Raleigh, North Carolina, United States
• Mercy St. Vincent Medical Center — Toledo, Ohio, United States
• Center for Sleep Medicine — Philadelphia, Pennsylvania, 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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