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NCT01485770 · ClinicalTrials.gov registry record · Phase 2
A Study of the Safety and Effectiveness of ADX-N05 in the Treatment of Excessive Daytime Sleepiness
A Phase 2 study of Narcolepsy, sponsored by Jazz Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 33
- Enrollment target
- 10
- Study locations
NCT01485770: Completed Phase 2 study of Narcolepsy, sponsored by Jazz Pharmaceuticals.
NCT01485770 is a Phase 2 study of Narcolepsy that has completed, run by Jazz Pharmaceuticals. The registered enrollment target is 33 participants, below the 378-participant average among 12 other Narcolepsy trials with a reported enrollment target (91% lower). The trial reports 10 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01485770, a Phase 2 study of Narcolepsy, has completed, sponsored by Jazz Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 33 participants
- Enrollment target
- 10
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG ADX-N05
Study Locations (10)
Georgia
- Neurotrials Research, Inc. - Atlanta
- Sleep Disorders Center of Georgia - Atlanta
- SleepMed of Central Georgia - Macon
Texas
- Future Search Trials of Neurology - Austin
- Sleep Medicine Associates of Texas - Dallas
Arizona
- Pulmonary Associates - Phoenix
Florida
- Clinical Research Group of St. Petersburg - St. Petersburg
Maryland
- The Center for Sleep and Wake Disorders - Chevy Chase
Ohio
- Mercy St. Anne Sleep Disorders Center - Toledo
South Carolina
- SleepMed of South Carolina - Columbia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2011-12 |
| Est. Completion | 2012-05 |
| Phase | Phase 2 |
What the finished NCT01485770 record still lists
NCT01485770 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 378-participant average among 12 other Narcolepsy trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Narcolepsy appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01485770 lists 10 locations in 7 states (Georgia, Texas, Arizona).
Frequently Asked Questions
What is clinical trial NCT01485770 about?
NCT01485770 is a clinical study titled "A Study of the Safety and Effectiveness of ADX-N05 in the Treatment of Excessive Daytime Sleepiness". 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.
What is the current status of trial NCT01485770?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 33 participants. The study started on 2011-12. Estimated completion is 2012-05.
What conditions does trial NCT01485770 study?
This clinical trial studies the following conditions: Narcolepsy.
What interventions are being tested in trial NCT01485770?
The interventions under investigation include: Placebo (DRUG), ADX-N05 (DRUG).
Who is sponsoring clinical trial NCT01485770?
This trial is sponsored by Jazz Pharmaceuticals, which has 128 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01485770 being conducted?
This trial has 10 study locations across Arizona, Florida, Georgia, Maryland, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Narcolepsy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01485770's enrollment target sits among peer trials
33 11th of 12 higher than 2 of 12 other Narcolepsy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Narcolepsy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study of the Safety and Effectiveness of ADX-N05 for Excessive Daytime Sleepiness in Subjects With Narcolepsy
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Child and Adolescent Registry for Participants With Narcolepsy
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WAKIX® (Pitolisant) Pregnancy Registry
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Narcolepsy Nightmare Study
COMPLETED · NA
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