A Study of the Safety and Effectiveness of ADX-N05 in the Treatment of Excessive Daytime Sleepiness
A Four-week, Double-blind, Placebo-controlled, Randomized, Cross-over Study of the Safety and Efficacy of ADX-N05 in the Treatment of Excessive Daytime Sleepiness
1 other identifier
interventional
33
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Dec 2011
Shorter than P25 for phase_2
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
December 2, 2011
CompletedFirst Posted
Study publicly available on registry
December 6, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedResults Posted
Study results publicly available
July 6, 2021
CompletedJuly 6, 2021
June 1, 2021
5 months
December 2, 2011
April 28, 2021
June 11, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in the Average Sleep Latency Time (in Minutes) as Determined From the Maintenance of Wakefulness Test (MWT) Following Two Weeks of Treatment With ADX-N05 vs. Two Weeks of Treatment With Placebo
The MWT is a validated objective measure of the ability to stay awake for a defined period of time. The change from baseline in the mean sleep latency from the MWT was the average of sleep latency from the four trials of the MWT.
Baseline up to 2 weeks post-dose.
Secondary Outcomes (4)
Change From Baseline in Epworth Sleepiness Scale (ESS) Score During Weeks 1 and 3
Baseline up to Week 3 post-dose.
Change From Baseline in Epworth Sleepiness Scale (ESS) Score During Weeks 2 and 4
Baseline up to Week 4 post-dose.
Number of Participants With Improved Clinical Global Impression of Change (CGI-C) Scores During Weeks 1 and 3
Week 1 and Week 3 post-dose.
Number of Participants With Improved Clinical Global Impression of Change (CGI-C) Scores During Weeks 2 and 4
Week 2 and Week 4 post-dose.
Study Arms (2)
Placebo, Then ADX-N05
EXPERIMENTALParticipants first receive a placebo to match ADX-N05 once a day for 2 consecutive weeks (Weeks 1 and 2). They will then receive ADX-N05 150 mg tablet once a day for seven days (Week 3) followed by 300 mg (2 tablets) once a day for seven days (Week 4).
ADX-N05, Then Placebo
PLACEBO COMPARATORParticipants first receive ADX-N05 150 mg tablet once a day for seven days (Week 1) followed by 300 mg (2 tablets) once a day for seven days (Week 2). They will then receive a placebo to match ADX-N05 once a day for 2 consecutive weeks (Weeks 3 and 4).
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Pulmonary Associates
Phoenix, Arizona, 85006, United States
Clinical Research Group of St. Petersburg
St. Petersburg, Florida, 33707, United States
Neurotrials Research, Inc.
Atlanta, Georgia, 30342, United States
Sleep Disorders Center of Georgia
Atlanta, Georgia, 30342, United States
SleepMed of Central Georgia
Macon, Georgia, 31201, United States
The Center for Sleep and Wake Disorders
Chevy Chase, Maryland, 20815, United States
Mercy St. Anne Sleep Disorders Center
Toledo, Ohio, 43623, United States
SleepMed of South Carolina
Columbia, South Carolina, 29201, United States
Future Search Trials of Neurology
Austin, Texas, 78731, United States
Sleep Medicine Associates of Texas
Dallas, Texas, 75231, United States
Related Publications (1)
Bogan RK, Feldman N, Emsellem HA, Rosenberg R, Lu Y, Bream G, Khayrallah M, Lankford DA. Effect of oral JZP-110 (ADX-N05) treatment on wakefulness and sleepiness in adults with narcolepsy. Sleep Med. 2015 Sep;16(9):1102-8. doi: 10.1016/j.sleep.2015.05.013. Epub 2015 Jun 3.
PMID: 26298786DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director, Disclosure & Transparency
- Organization
- Jazz Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 2, 2011
First Posted
December 6, 2011
Study Start
December 1, 2011
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
July 6, 2021
Results First Posted
July 6, 2021
Record last verified: 2021-06