Phase 2 N=93 Randomized Triple-blind Treatment

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

Narcolepsy

Bottom Line

View on ClinicalTrials.gov: NCT01681121 ↗

Enrolled (actual)

Serious AEs

2.2%

Results posted

Sep 2014

Primary outcome: Primary: 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. — 12.8; 2.1 minutes

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: ADX-N05 (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Jazz Pharmaceuticals
Primary completion: Aug 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY 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.	12.8; 2.1	—
PRIMARY Number of Participants With Improved Clinical Global Impression of Change (CGI-C) Scores for ADX-N05 vs. Placebo at Last Assessment	37; 18	—
SECONDARY 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	9.5; 1.4	—
SECONDARY 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	11.7; 1.6; 9.7; 1.0; 9.9; 1.3	—
SECONDARY 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	15.5; 2.6; 13.4; 2.7; 11.4; 2.0	—
SECONDARY Change From Baseline in Epworth Sleepiness Scale (ESS) Scores for ADX-N05 vs. Placebo at Week 4	-5.6; -2.4	—
SECONDARY Change From Baseline in ESS Scores for ADX-N05 vs. Placebo at Last Assessment	-8.5; -2.5	—
SECONDARY Number of Participants With Improved Clinical Global Impression of Change (CGI-C) Scores for ADX-N05 vs. Placebo at Week 4	32; 23	—
SECONDARY Number of Participants With Improved Patient Global Impression Change (PGI-C) Scores for ADX-N05 vs. Placebo at Week 4	33; 20	—
SECONDARY Number of Participants With Improved PGI-C Scores for ADX-N05 vs. Placebo at Last Assessment	40; 18	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01681121). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.