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NCT02316847 · ClinicalTrials.gov registry record · Phase 2
An Open-Label, Safety and Tolerability Study of Chronic Intermittent Use of Diazepam Nasal Spray.
A Phase 2 study, sponsored by Acorda Therapeutics.
- Terminated
- Registry status
- Phase 2
- Development phase
- 126
- Enrollment target
NCT02316847: Clinical Trial Phase 2 study, sponsored by Acorda Therapeutics.
NCT02316847 is a Phase 2 study that was terminated before completion, run by Acorda Therapeutics. The registered enrollment target is 126 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02316847, a Phase 2 study, was terminated before completion, sponsored by Acorda Therapeutics.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 126 participants
- Enrollment target
Study Summary
This study will assess long-term safety and tolerability of repeat dose diazepam nasal spray in adolescents and adults with cluster seizures, with a focus on potential local effects (changes in nasal mucosa, olfaction, and taste).
Primary Outcome
The SIT is a 50-item multiple-choice standardized test of olfactory function. Scoring of the test in the ability to smell ranges from normal (Normosmia: score 35 - 40 Women; 34 - 40 Men); to inability to smell (Anosmia score 6 - 18); or Malingering (not engaged in the test) ranges 0 - 5.
Interventions
- DRUG diazepam nasal spray
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 126 participants |
| Start Date | 2014-12 |
| Est. Completion | 2016-09 |
| Phase | Phase 2 |
Why NCT02316847 stopped before completion
NCT02316847 is an interventional study that assigns participants to a tested intervention. The registered 126 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which diazepam nasal spray is the first listed.
NCT02316847 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02316847 about?
NCT02316847 is a clinical study titled "An Open-Label, Safety and Tolerability Study of Chronic Intermittent Use of Diazepam Nasal Spray.". This study will assess long-term safety and tolerability of repeat dose diazepam nasal spray in adolescents and adults with cluster seizures, with a focus on potential local effects (changes in nasal mucosa, olfaction, and taste).
What is the current status of trial NCT02316847?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 126 participants. The study started on 2014-12. Estimated completion is 2016-09.
What interventions are being tested in trial NCT02316847?
The interventions under investigation include: diazepam nasal spray (DRUG).
Who is sponsoring clinical trial NCT02316847?
This trial is sponsored by Acorda Therapeutics, which has 36 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02316847's enrollment target sits among peer trials
126 556th of 2000 higher than 1,443 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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