Clinical trial NCT01681121: A Study of the Safety and Effectiveness of ADX-N05 for Excessive Daytime Sleepiness in Subjects With Narcolepsy
Official title: A Twelve-week, Double-blind, Placebo-controlled, Randomized, Parallel-group, Multi-center Study of the Safety and Efficacy of ADX-N05 in the Treatment of Excessive Daytime Sleepiness in Subjects With Narcolepsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Narcolepsy
Lead sponsor: Jazz Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2012-09-07
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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 2 years
* Nicotine dependence that has an effect 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) for ADX-N05 300 mg vs. Placebo at Last Assessment.
timeFrame: Baseline up to Week 12/Last Assessment post-dose.
measure: Number of Participants With Improved Clinical Global Impression of Change (CGI-C) Scores for ADX-N05 vs. Placebo at Last Assessment
timeFrame: Week 12
Secondary outcomes:
measure: Change From Baseline in the Average Sleep Latency Time (in Minutes) as Determined From the Maintenance of Wakefulness Test (MWT) (Average of the First Four Trials) Following Four Weeks of Treatment With ADX-N05 150 mg vs. Placebo
timeFrame: Baseline up to Week 4 post-dose.
measure: Change From Baseline in Sleep Latency Time (in Minutes) as Determined From Each of the 5 Individual MWT Trials for ADX-N05 vs. Placebo at Week 4
timeFrame: Baseline up to Week 4 post-dose.
measure: Change From Baseline in Sleep Latency Time (in Minutes) as Determined From Each of the 5 Individual MWT Trials for ADX-N05 vs. Placebo at Last Assessment
timeFrame: Baseline up to Week 12/Last Assessment post-dose.
measure: Change From Baseline in Epworth Sleepiness Scale (ESS) Scores for ADX-N05 vs. Placebo at Week 4
timeFrame: Baseline up to Week 4 post-dose.
measure: Change From Baseline in ESS Scores for ADX-N05 vs. Placebo at Last Assessment
timeFrame: Baseline up to Week 12/Last Assessment post-dose.
measure: Number of Participants With Improved Clinical Global Impression of Change (CGI-C) Scores for ADX-N05 vs. Placebo at Week 4
timeFrame: Week 4
measure: Number of Participants With Improved Patient Global Impression Change (PGI-C) Scores for ADX-N05 vs. Placebo at Week 4
timeFrame: Week 4
measure: Number of Participants With Improved PGI-C Scores for ADX-N05 vs. Placebo at Last Assessment
timeFrame: Week 12/Last Assessment
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Sleep Disorders Center of Alabama
state: Alabama
city: Phoenix
country: United States
facility: Pulmonary Associates
state: Arizona
city: Redwood City
country: United States
facility: Stanford Sleep Medicine Center
state: California
city: San Diego
country: United States
facility: Pacific Research Network
state: California
city: Aurora
country: United States
facility: Sleep-Alertness Disorders Center
state: Colorado
city: Brandon
country: United States
facility: PAB Clinical Research
state: Florida
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: Chicago
country: United States
facility: Chicago Research Center
state: Illinois
city: Crestview Hills
country: United States
facility: Community Research
state: Kentucky
city: Louisville
country: United States
facility: Kentucky Research Group
state: Kentucky
city: Chevy Chase
country: United States
facility: The Center for Sleep and Wake Disorders
state: Maryland
city: Towson
country: United States
facility: Pulmonary and Critical Care Associates of Baltimore
state: Maryland
city: Newton
country: United States
facility: Neurocare, Inc.
state: Massachusetts
city: Edina
country: United States
facility: Minnesota Lung Center and Sleep Institute
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Raleigh
country: United States
facility: Rex Sleep Disorders Center
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates
state: North Carolina
city: Toledo
country: United States
facility: Mercy St. Vincent Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: Center for Sleep Medicine
state: Pennsylvania
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
city: Houston
country: United States
facility: Todd J. Swick, MD, PA
state: Texas
city: McKinney
country: United States
facility: Metroplex Pulmonary and Sleep Center
state: Texas
city: San Antonio
country: United States
facility: Sleep Therapy and Research Center
state: Texas
Study officials:
affiliation: Aerial BioPharma, LLC
name: David Ward, MD
role: STUDY_DIRECTOR
References:
citation: 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.