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NCT06128356 · ClinicalTrials.gov registry record · Phase 2
Pilot Study of Dexmedetomidine Sublingual Film for the Ambulatory Treatment of Hyperadrenergic Autonomic Crisis in Patients With Familial Dysautonomia
A Phase 2 study of Familial Dysautonomia, sponsored by NYU Langone Health.
- Active
- Registry status
- Phase 2
- Development phase
- 5
- Enrollment target
- 1
- Study location
NCT06128356: Active Phase 2 study of Familial Dysautonomia, sponsored by NYU Langone Health.
NCT06128356 is a Phase 2 study of Familial Dysautonomia that is active but no longer recruiting, run by NYU Langone Health. The registered enrollment target is 5 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06128356, a Phase 2 study of Familial Dysautonomia, is active but no longer recruiting, sponsored by NYU Langone Health.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 5 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a pilot open-label study to evaluate the feasibility of conducting a clinical trial using sublingual dexmedetomidine sublingual film to treat hyperadrenergic autonomic crises in patients with Familial Dysautonomia at home. The primary aims are to examine the feasibility of performing a clinical trial using dexmedetomidine at home to terminate autonomic crisis, and refine the interventions and assessments used to evaluate autonomic crisis termination.
Conditions Studied
Interventions
- DRUG Dexmedetomidine Sublingual
Study Locations (1)
New York
- NYU Langone Health - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2024-06-01 |
| Est. Completion | 2028-12 |
| Phase | Phase 2 |
What the registry record for NCT06128356 still lists
NCT06128356 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Familial Dysautonomia appearing as the primary indexed condition, and to 1 intervention - of which Dexmedetomidine Sublingual is the first listed.
NCT06128356 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT06128356 about?
NCT06128356 is a clinical study titled "Pilot Study of Dexmedetomidine Sublingual Film for the Ambulatory Treatment of Hyperadrenergic Autonomic Crisis in Patients With Familial Dysautonomia". This is a pilot open-label study to evaluate the feasibility of conducting a clinical trial using sublingual dexmedetomidine sublingual film to treat hyperadrenergic autonomic crises in patients with Familial Dysautonomia at home. The primary aims are to examine the feasibility of performing a clini...
What is the current status of trial NCT06128356?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 5 participants. The study started on 2024-06-01. Estimated completion is 2028-12.
What conditions does trial NCT06128356 study?
This clinical trial studies the following conditions: Familial Dysautonomia.
What interventions are being tested in trial NCT06128356?
The interventions under investigation include: Dexmedetomidine Sublingual (DRUG).
Who is sponsoring clinical trial NCT06128356?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06128356 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06128356's enrollment target sits among peer trials
5 2000th of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
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Source ClinicalTrials.gov registry export · 2026-08-08
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