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NCT05273398 · ClinicalTrials.gov registry record · Phase 4
Effects of Diazepam on RNS Detections
A Phase 4 study, sponsored by University of Cincinnati.
- Completed
- Registry status
- Phase 4
- Development phase
- 4
- Enrollment target
NCT05273398: Completed Phase 4 study, sponsored by University of Cincinnati.
NCT05273398 is a Phase 4 study that has completed, run by University of Cincinnati. The registered enrollment target is 4 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05273398, a Phase 4 study, has completed, sponsored by University of Cincinnati.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 4 participants
- Enrollment target
Study Summary
To assess the magnitude and duration of reduction in RNS recorded Detections and Long Episodes following intranasal administration of Valtoco®. All participants will have been implanted and treated with an RNS system for clinical purposes and regularly upload Detection and Long Episode data on a regular basis as part of regular clinical treatment. Participants will come to the clinic and be administered a single dose of Valtoco® via nasal spray. RNS recorded Detections and Long Episodes before and after Valtoco® administration will be compared. This is a pilot study, so all outcomes are exploratory.
Primary Outcome
The investigators will assess the percent change in Detections calculated separately for each hour during the first 8 hours of the post-dose observation period. The number of Detections during each hour of the 8-hour period post dose will be compared to the same hour during the seven comparable 8-hour sessions of the 7-day pre-dose observation period.
Interventions
- DRUG nasal diazepam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2022-03-01 |
| Est. Completion | 2022-11-10 |
| Phase | Phase 4 |
What the finished NCT05273398 record still lists
NCT05273398 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which nasal diazepam is the first listed.
NCT05273398 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05273398 about?
NCT05273398 is a clinical study titled "Effects of Diazepam on RNS Detections". To assess the magnitude and duration of reduction in RNS recorded Detections and Long Episodes following intranasal administration of Valtoco®. All participants will have been implanted and treated with an RNS system for clinical purposes and regularly upload Detection and Long Episode data on a reg...
What is the current status of trial NCT05273398?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 4 participants. The study started on 2022-03-01. Estimated completion is 2022-11-10.
What interventions are being tested in trial NCT05273398?
The interventions under investigation include: nasal diazepam (DRUG).
Who is sponsoring clinical trial NCT05273398?
This trial is sponsored by University of Cincinnati, which has 245 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05273398's enrollment target sits among peer trials
4 1994th of 2000 higher than 6 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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