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NCT02348632 · ClinicalTrials.gov registry record · Phase 3
"A Long-Term Safety Study of JZP-110 in the Treatment of Excessive Sleepiness in Subjects With Narcolepsy or OSA"
A Phase 3 study, sponsored by Jazz Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 645
- Enrollment target
NCT02348632: Completed Phase 3 study, sponsored by Jazz Pharmaceuticals.
NCT02348632 is a Phase 3 study that has completed, run by Jazz Pharmaceuticals. The registered enrollment target is 645 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (16% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02348632, a Phase 3 study, has completed, sponsored by Jazz Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 645 participants
- Enrollment target
Study Summary
This is a Phase 3 study to assess the long-term safety and maintenance of efficacy of JZP-110 in subjects who have completed Study 14-002, 14-003, 14-004, 15-004, 15-005, ADX-N05 201, or ADX-N05 202.
Primary Outcome
Change in Epworth Sleepiness Scale (ESS) score during the 2-week randomized withdrawal period. The beginning of the randomized withdrawal period represents efficacy baseline. A negative change from baseline represents improvement in excessive sleepiness. The ESS is a self-administered questionnaire with 8 questions. Each activity is scored on a scale ranging from 0-3, with 0 = would never fall asleep, and 3 = high chance of falling asleep. The total score ranges from 0-24, with a higher number
Interventions
- DRUG JZP-110
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 645 participants |
| Start Date | 2015-05 |
| Est. Completion | 2017-12 |
| Phase | Phase 3 |
What the finished NCT02348632 record still lists
NCT02348632 is an interventional study that assigns participants to a tested intervention. The registered 645 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (16% lower).
The record links to 0 conditions, and to 1 intervention - of which JZP-110 is the first listed.
NCT02348632 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02348632 about?
NCT02348632 is a clinical study titled ""A Long-Term Safety Study of JZP-110 in the Treatment of Excessive Sleepiness in Subjects With Narcolepsy or OSA"". This is a Phase 3 study to assess the long-term safety and maintenance of efficacy of JZP-110 in subjects who have completed Study 14-002, 14-003, 14-004, 15-004, 15-005, ADX-N05 201, or ADX-N05 202.
What is the current status of trial NCT02348632?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 645 participants. The study started on 2015-05. Estimated completion is 2017-12.
What interventions are being tested in trial NCT02348632?
The interventions under investigation include: JZP-110 (DRUG).
Who is sponsoring clinical trial NCT02348632?
This trial is sponsored by Jazz Pharmaceuticals, which has 128 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02348632's enrollment target sits among peer trials
645 572nd of 2000 higher than 1,429 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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
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