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A Study of the Safety and Effectiveness of ADX-N05 for Excessive Daytime Sleepiness in Subjects With Narcolepsy
NCT01681121 · View on ClinicalTrials.gov ↗
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG ADX-N05
Study Locations (20)
Georgia
- NeuroTrials Research, Inc. — Atlanta
- Sleep Disorders Center of Georgia — Atlanta
- SleepMed of Central Georgia — Macon
California
- Stanford Sleep Medicine Center — Redwood City
- Pacific Research Network — San Diego
Florida
- PAB Clinical Research — Brandon
- Clinical Research Group of St. Petersburg — St. Petersburg
Kentucky
- Community Research — Crestview Hills
- Kentucky Research Group — Louisville
Maryland
- The Center for Sleep and Wake Disorders — Chevy Chase
- Pulmonary and Critical Care Associates of Baltimore — Towson
North Carolina
- Rex Sleep Disorders Center — Raleigh
- Wake Research Associates — Raleigh
Alabama
- Sleep Disorders Center of Alabama — Birmingham
Arizona
- Pulmonary Associates — Phoenix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 93 participants |
| Start Date | 2012-09 |
| Est. Completion | 2013-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01681121
The ClinicalTrials.gov registry entry for NCT01681121 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 93 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Jazz Pharmaceuticals, which has 37 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01681121 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Georgia, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01681121 about?
NCT01681121 is a clinical study titled "A Study of the Safety and Effectiveness of ADX-N05 for Excessive Daytime Sleepiness in Subjects With Narcolepsy". 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 NCT01681121?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 93 participants. The study started on 2012-09. Estimated completion is 2013-08.
What conditions does trial NCT01681121 study?
This clinical trial studies the following conditions: Narcolepsy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01681121?
The interventions under investigation include: Placebo (DRUG), ADX-N05 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01681121?
This trial is sponsored by Jazz Pharmaceuticals, which has 37 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01681121 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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