drugset / Trial / NCT02608931

The Safety, Tolerability and Efficacy of Dronabinol, for the Treatment of Nausea and Vomiting in Familial Dysautonomia

NCT02608931

Phase 2 Withdrawn NYU Langone Health
RandomizedCrossoverDouble-blindTreatment

Summary

This is a pilot clinical trial of dronabinol to treat disabling attacks of nausea and vomiting in patients with familial dysautonomia (FD, also known as Riley Day syndrome or hereditary sensory and autonomic neuropathy type III). FD is a rare autosomal recessive disease in which the growth and development of selective nerves is impaired. Patients with FD suffer recurrent uncontrollable nausea and vomiting crises accompanied by skin flushing, tachycardia and arterial hypertension. Current treatments of nausea are ineffective or have intolerable side sides. Our long-term goal is to treat nausea effectively and without side effects, a therapeutic intervention that would markedly improve the quality of life of patients with FD.

Timeline

Start
2015-11
Primary completion
2019-03-22
Completion
2019-03-22

Drugs

EvaluationDrugModalityDoseRoute
Subject Dronabinol Other / unclassified 2.5 mg
Subject Dronabinol Other / unclassified 10 mg

Indications