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NCT05219604 · ClinicalTrials.gov registry record · Phase 4
Central Nervous System Effects Following Infusion of Diphenhydramine Using Pharmacokinetic and Pharmacodynamic Modeling
A Phase 4 study, sponsored by Dent Neuroscience Research Center.
- Terminated
- Registry status
- Phase 4
- Development phase
- 3
- Enrollment target
NCT05219604: Clinical Trial Phase 4 study, sponsored by Dent Neuroscience Research Center.
NCT05219604 is a Phase 4 study that was terminated before completion, run by Dent Neuroscience Research Center. The registered enrollment target is 3 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
NCT05219604, a Phase 4 study, was terminated before completion, sponsored by Dent Neuroscience Research Center.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 3 participants
- Enrollment target
Study Summary
This study seeks to explore the magnitude and duration of central nervous system effects and pharmacokinetics after intravenous infusion of diphenhydramine.
Primary Outcome
Change in the results of the CANTAB battery of cognitive function tests (reaction time, rapid visual information processing, paired associates learning, spatial working memory, digit span) and visual analog scale for sedation after diphenhydramine administration compared to baseline. Reaction Time Median Five-Choice Reaction Time is the median duration it took for a subject to release the response button after the presentation of the target stimulus, calculated across correct, assessed trials i
Interventions
- DRUG DiphenhydrAMINE Injectable Solution
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2022-03-15 |
| Est. Completion | 2022-10-04 |
| Phase | Phase 4 |
Why NCT05219604 stopped before completion
NCT05219604 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 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 DiphenhydrAMINE Injectable Solution is the first listed.
NCT05219604 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05219604 about?
NCT05219604 is a clinical study titled "Central Nervous System Effects Following Infusion of Diphenhydramine Using Pharmacokinetic and Pharmacodynamic Modeling". This study seeks to explore the magnitude and duration of central nervous system effects and pharmacokinetics after intravenous infusion of diphenhydramine.
What is the current status of trial NCT05219604?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 3 participants. The study started on 2022-03-15. Estimated completion is 2022-10-04.
What interventions are being tested in trial NCT05219604?
The interventions under investigation include: DiphenhydrAMINE Injectable Solution (DRUG).
Who is sponsoring clinical trial NCT05219604?
This trial is sponsored by Dent Neuroscience Research Center, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05219604's enrollment target sits among peer trials
3 1995th of 2000 higher than 3 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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