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ENROLLING BY INVITATION
NCT06148311
PHASE2

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

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

Interventions

DRUG

Matching placebo

One matching placebo will be given under the tongue on a thin dissolvable film.

DRUG

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