Clinical trial NCT01485770: A Study of the Safety and Effectiveness of ADX-N05 in the Treatment of Excessive Daytime Sleepiness
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Narcolepsy
Lead sponsor: Jazz Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2011-12-06
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: 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
timeFrame: Baseline up to 2 weeks post-dose.
Secondary outcomes:
measure: Change From Baseline in Epworth Sleepiness Scale (ESS) Score During Weeks 1 and 3
timeFrame: Baseline up to Week 3 post-dose.
measure: Change From Baseline in Epworth Sleepiness Scale (ESS) Score During Weeks 2 and 4
timeFrame: Baseline up to Week 4 post-dose.
measure: Number of Participants With Improved Clinical Global Impression of Change (CGI-C) Scores During Weeks 1 and 3
timeFrame: Week 1 and Week 3 post-dose.
measure: Number of Participants With Improved Clinical Global Impression of Change (CGI-C) Scores During Weeks 2 and 4
timeFrame: Week 2 and Week 4 post-dose.
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Pulmonary Associates
state: Arizona
city: Saint Petersburg
country: United States
facility: Clinical Research Group of St. Petersburg
state: Florida
city: Atlanta
country: United States
facility: Neurotrials Research, Inc.
state: Georgia
city: Atlanta
country: United States
facility: Sleep Disorders Center of Georgia
state: Georgia
city: Macon
country: United States
facility: SleepMed of Central Georgia
state: Georgia
city: Chevy Chase
country: United States
facility: The Center for Sleep and Wake Disorders
state: Maryland
city: Toledo
country: United States
facility: Mercy St. Anne Sleep Disorders Center
state: Ohio
city: Columbia
country: United States
facility: SleepMed of South Carolina
state: South Carolina
city: Austin
country: United States
facility: Future Search Trials of Neurology
state: Texas
city: Dallas
country: United States
facility: Sleep Medicine Associates of Texas
state: Texas
Study officials:
References:
citation: 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.