Dexmedetomidine Sublingual Film for Flare-Ups in Familial Dysautonomia
Official title: Dexmedetomidine Sublingual Film for the Ambulatory Treatment of Hyperadrenergic Autonomic Crisis in Patients with Familial Dysautonomia
Funded at New York University School of Medicine · NIH-11361421 · Data updated 2026-11-12
A new dexmedetomidine pill under the tongue is being tested to help people with familial dysautonomia manage sudden sympathetic flare-ups at home.
Quick facts
| Grant type | R01 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | New York University School of Medicine NIH-funded |
| Lab location | 1 site (New York, United States) |
| Project start | September 15, 2023 |
| Project end | August 31, 2028 |
| Funding year | 2026 |
| Award (this year) | $647,319 |
| NIH project number | 5R01FD007826-04 |
| Project ID | NIH-11361421 on NIH RePORTER |
Who could benefit from this research
✓Could help
Ideal candidates are individuals with familial dysautonomia who experience recurrent hyperadrenergic autonomic crises and can use sublingual medications.
✕Less likely to help
Patients without FD or those not experiencing autonomic crises may not benefit from this specific intervention.
What this research studies
People with familial dysautonomia experience painful, sometimes dangerous episodes where their blood pressure and heart rate spike, often triggered by illness or stress. This trial tests a sublingual dexmedetomidine formulation to abort or prevent these autonomic crises outside the hospital, aiming for a safer home-based option. Researchers will monitor how well this at-home treatment reduces crisis frequency and severity, and how easy and safe the formulation is to use in daily life. The study builds on a specific disease condition and involves patients who experience these autonomic crises as part of their usual care.
Why it matters
Potential benefit: If successful, patients could have a safer, simpler at-home option to stop or lessen autonomic crises.
How similar studies have gone: There is a need for safer home-based crisis management; prior home-approach strategies are not disease-specific and can have limitations, making this approach relatively novel for FD.
Where this research is happening
-
New York University School of Medicine
New York, United States Active
Researchers
- Principal investigator: Gonzalez-Duarte Briseno, Maria Alejandra — New York University School of Medicine
- Study coordinator: Gonzalez-Duarte Briseno, Maria Alejandra
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About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.