NCT06148311

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

• Status: Enrolling By Invitation
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 16 Years – 80 Years
• Healthy volunteers: Not accepted

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

Conditions

• Familial Dysautonomia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-07-01
• Primary completion: 2027-01-01
• Completion: 2027-09-01
• First posted: 2023-11-28
• Last updated: 2026-04-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study