NCT06148311View on ClinicalTrials.gov

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

PHASE2Enrolling by invitationINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

July 1, 2024

Primary Completion Date

January 1, 2027

Study Completion Date

September 1, 2027

Conditions
Familial Dysautonomia
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.

Trial Locations (1)

10016

NYU Langone Health, New York

All Listed Sponsors
collaborator

Food and Drug Administration (FDA)

FED

lead

NYU Langone Health

OTHER