Status:
COMPLETED
Carbidopa for the Treatment of Nausea and Vomiting in Familial Dysautonomia
Lead Sponsor:
NYU Langone Health
Conditions:
Familial Dysautonomia
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
This is a pilot clinical trial of carbidopa to treat disabling attacks of nausea and vomiting in patients with familial dysautonomia (FD, also known as Riley Day syndrome or hereditary sensory and aut...
Detailed Description
Patients with familial dysautonomia (FD), also called Riley Day syndrome or hereditary sensory and autonomic neuropathy type III, suffer recurrent attacks of uncontrollable nausea and vomiting that ca...
Eligibility Criteria
Inclusion
- Male of female patients aged 12 and older
- Confirmed diagnosis of familial dysautonomia by genetic testing.
- Symptoms of severe nausea
- Written informed consent or ascent to participate in the pilot trial and understanding that they can withdraw consent at anytime without affecting their future care.
- Ability to comply with the requirements of the study procedures, including taking blood pressure measurements at home.
Exclusion
- Patients taking metroclopromide, domperidone, risperidone or other dopamine blockers
- Patients taking MAO-inhibitors
- Patients taking tricyclic antidepressants
- Patients taking neuroleptic drugs (haloperidol and chlorpromazine)
- Patients with a known hypersensitivity to any component of this drug.
- Patients with atrial fibrillation, angina or an electrocardiogram documenting significant abnormality that may jeopardize the patient's health.
- Patients with significant pulmonary, liver, renal (creatinine \>2.0 mg/ml) or cardiac illness
- Patients who are unable to clearly identify and rate their symptoms of nausea.
- Women who are pregnant or lactating
- Patients who have a significant abnormality on clinical examination that may, in
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01212484
Start Date
December 1 2009
End Date
October 1 2012
Last Update
March 28 2016
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