A Study of the Safety and Effectiveness of ADX-N05 for Excessive Daytime Sleepiness in Subjects With Narcolepsy
NCT ID: NCT01681121
Last Updated: 2021-05-28
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
93 participants
INTERVENTIONAL
2012-09-30
2013-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of the Safety and Effectiveness of ADX-N05 in the Treatment of Excessive Daytime Sleepiness
NCT01485770
A Study to Assess the Efficacy and Safety of AXS-12 (Reboxetine) in Patients With Narcolepsy
NCT05059223
"A Long-Term Safety Study of JZP-110 in the Treatment of Excessive Sleepiness in Subjects With Narcolepsy or OSA"
NCT02348632
"Twelve-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in Narcolepsy"
NCT02348593
A Multiple Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JZP441 in Healthy Participants
NCT05720494
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ADX-N05
ADX-N05 to be taken once a day for 12 weeks
ADX-N05
150 mg once a day for 4 weeks followed by 300 mg once a day for 8 weeks
Placebo
Placebo to match ADX-N05 to be taken once a day for 12 weeks
Placebo
One capsule placebo to match ADX-N05 to be taken for 4 weeks followed by 2 capsules placebo to match ADX-N05 to be taken for 8 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ADX-N05
150 mg once a day for 4 weeks followed by 300 mg once a day for 8 weeks
Placebo
One capsule placebo to match ADX-N05 to be taken for 4 weeks followed by 2 capsules placebo to match ADX-N05 to be taken for 8 weeks
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Good general health
* Willing and able to comply with the study design and schedule and other requirements
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Jazz Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
David Ward, MD
Role: STUDY_DIRECTOR
Aerial BioPharma, LLC
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Todd J. Swick, MD, PA
Houston, Texas, United States
Metroplex Pulmonary and Sleep Center
McKinney, Texas, United States
Sleep Therapy and Research Center
San Antonio, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Ruoff C, Swick TJ, Doekel R, Emsellem HA, Feldman NT, Rosenberg R, Bream G, Khayrallah MA, Lu Y, Black J. Effect of Oral JZP-110 (ADX-N05) on Wakefulness and Sleepiness in Adults with Narcolepsy: A Phase 2b Study. Sleep. 2016 Jul 1;39(7):1379-87. doi: 10.5665/sleep.5968.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ADX-N05 202
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.