NYU Langone Health
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
Inclusion Criteria: * Genetically confirmed diagnosis of Familial Dysautonomia. * One or more autonomic crises during the last year. * Our database shows evidence of autonomic crisis, previous treatment with IV dexmedetomidine, and registered medical data within the year preceding the study. * Age 16 years or older * The patient has a responsible caretaker to communicate with the medical providers. * Provision of signed and dated informed consent form from the patient and responsible caregiver * Able to state willingness to comply with all study procedures and availability for the duration of…
One matching placebo will be given under the tongue on a thin dissolvable film.
Dexmedetomidine 120 mcg will be given under the tongue on a thin dissolvable film.
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