Phase 2
N=33
A Study of the Safety and Effectiveness of ADX-N05 in the Treatment of Excessive Daytime Sleepiness
Narcolepsy
Bottom Line
View on ClinicalTrials.gov: NCT01485770 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcome: Primary: 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 — 12.7; 0.9 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
- May 2012
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) Following Two Weeks of Treatment With ADX-N05 vs. Two Weeks of Treatment With Placebo |
12.7; 0.9 | — |
| SECONDARY Change From Baseline in Epworth Sleepiness Scale (ESS) Score During Weeks 1 and 3 |
-5.3; -1.2 | — |
| SECONDARY Change From Baseline in Epworth Sleepiness Scale (ESS) Score During Weeks 2 and 4 |
-6.7; -2.4 | — |
| SECONDARY Number of Participants With Improved Clinical Global Impression of Change (CGI-C) Scores During Weeks 1 and 3 |
29; 9 | — |
| SECONDARY Number of Participants With Improved Clinical Global Impression of Change (CGI-C) Scores During Weeks 2 and 4 |
25; 13 | — |
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
Data sourced from ClinicalTrials.gov (NCT01485770). 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.