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ACTIVE NOT RECRUITING
NCT06128356
PHASE2

Pilot Study of Dexmedetomidine Sublingual Film for the Ambulatory Treatment of Hyperadrenergic Autonomic Crisis in Patients With Familial Dysautonomia

Sponsor: NYU Langone Health

View on ClinicalTrials.gov

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

Interventions

DRUG

Dexmedetomidine Sublingual

Dexmedetomidine 120 mcg on two thin dissolvable films for sublingual administration

Locations (1)

NYU Langone Health

New York, New York, United States