Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01681121 · ClinicalTrials.gov registry record · Phase 2
A Study of the Safety and Effectiveness of ADX-N05 for Excessive Daytime Sleepiness in Subjects With Narcolepsy
A Phase 2 study of Narcolepsy, sponsored by Jazz Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 93
- Enrollment target
- 20
- Study locations
NCT01681121: Completed Phase 2 study of Narcolepsy, sponsored by Jazz Pharmaceuticals.
NCT01681121 is a Phase 2 study of Narcolepsy that has completed, run by Jazz Pharmaceuticals. The registered enrollment target is 93 participants, below the 373-participant average among 12 other Narcolepsy trials with a reported enrollment target (75% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01681121, a Phase 2 study of Narcolepsy, has completed, sponsored by Jazz Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 93 participants
- Enrollment target
- 20
- 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 primary analysis was a comparison of treatments vs. control groups on change from Baseline to last available post-Baseline assessment (Week 12/Last Assessment) in the average sleep latency time (in minutes) averaged across the first four trials of the MWT using a two-sample t-test.
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 |
What the finished NCT01681121 record still lists
NCT01681121 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 93 participants, a relatively small participant target, below the 373-participant average among 12 other Narcolepsy trials with a reported enrollment target (75% 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.
NCT01681121 names 20 study sites across 13 states, led by Georgia, California, Florida.
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.
What interventions are being tested in trial NCT01681121?
The interventions under investigation include: Placebo (DRUG), ADX-N05 (DRUG).
Who is sponsoring clinical trial NCT01681121?
This trial is sponsored by Jazz Pharmaceuticals, which has 128 total clinical trials registered on ClinicalTrials.gov.
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.
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 NCT01681121's enrollment target sits among peer trials
93 8th of 12 higher than 5 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 in the Treatment of Excessive Daytime Sleepiness
COMPLETED · Phase 2
-
SUNOSI® (Solriamfetol) Pregnancy Registry
RECRUITING
-
A Study to Investigate Efficacy, Safety, Tolerability, and Pharmacokinetics of JZP441 Compared With Placebo in Participants With Narcolepsy Type 1
RECRUITING · Phase 1
-
Child and Adolescent Registry for Participants With Narcolepsy
RECRUITING
-
WAKIX® (Pitolisant) Pregnancy Registry
RECRUITING
-
Narcolepsy Nightmare Study
COMPLETED · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02203526 · 93 participants · Phase 1
Phase 1 Study of Ibrutinib and Immuno-Chemotherapy Using Temozolomide, Etoposide, Doxil, Dexamethasone, Ibrutinib,Rituximab (TEDDI-R) in Primary CNS Lymphoma
- NCT03089554 · 93 participants · Phase 2
Evaluating Genomic Testing in Human Cancer & Outcomes of Targeted Therapies
- NCT05000021 · 93 participants · NA
Reducing Diabetes Distress Using Cognitive Behavioral Therapy in Young Adults With Type 1 Diabetes
- NCT05489887 · 93 participants · Phase 2
Naxitamab Added to Induction for Newly Diagnosed High-Risk Neuroblastoma
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia