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Pilot Study of Dexmedetomidine Sublingual Film for the Ambulatory Treatment of Hyperadrenergic Autonomic Crisis in Patients With Familial Dysautonomia
Sponsor: NYU Langone Health
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.
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
5
Start Date
2024-06-01
Completion Date
2028-12
Last Updated
2026-03-04
Healthy Volunteers
No
Conditions
Interventions
Dexmedetomidine Sublingual
Dexmedetomidine 120 mcg on two thin dissolvable films for sublingual administration
Locations (1)
NYU Langone Health
New York, New York, United States