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Dexmedetomidine Sublingual Film for the Ambulatory Treatment of Hyperadrenergic Autonomic Crisis in Patients With Familial Dysautonomia
Sponsor: NYU Langone Health
Summary
The purpose of this placebo controlled interventional study is to collect preliminary data on administering dexmedetomidine in patients with Familial Dysautonomia (FD) during a rapid cessation of autonomic crisis. The primary aims are to assess the feasibility and evaluate if measurements of heart rate, blood pressure and oxygen saturation can predict the start of an autonomic crisis. Funding Source- FDA OOPD
Key Details
Gender
All
Age Range
16 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
15
Start Date
2024-07-01
Completion Date
2027-09-01
Last Updated
2025-06-04
Healthy Volunteers
No
Conditions
Interventions
Matching placebo
One matching placebo will be given under the tongue on a thin dissolvable film.
Dexmedetomidine
Dexmedetomidine 120 mcg will be given under the tongue on a thin dissolvable film.
Locations (1)
NYU Langone Health
New York, New York, United States