Status:
COMPLETED
The Nutritional Supplement Phosphatidylserine in Patients With Familial Dysautonomia
Lead Sponsor:
NYU Langone Health
Conditions:
Familial Dysautonomia
Eligibility:
All Genders
12+ years
Phase:
PHASE2
Brief Summary
Familial dysautonomia (FD) is a devastating hereditary disease in which the development of selective neuronal populations is impaired because of a deficiency of the protein IKAP (Slaugenhaupt, 2002). ...
Detailed Description
Familial dysautonomia (FD) is an autosomal recessive disease caused by mutations in the I-B kinase complex associated protein (IKBKAP) gene sequence (Anderson et al., 2001; Slaugenhaupt et al., 2001)....
Eligibility Criteria
Inclusion
- \- Diagnosis of familial dysautonomia (with mutation testing)
- Age 12 years or older
- Signed informed consent (or ascent), which will include permission to assess medical records
Exclusion
- Patients with significant cardiac, respiratory, or renal compromise that, in the investigators opinion, may jeopardize their health by participating in this trial
- Patients who are currently participating in other clinical trials of compounds that my change IKAP gene expression.
- Women who are pregnant or lactating
- Women of childbearing potential who are not using medically accepted methods of contraception.
- Patients taking anticoagulants, such as warfarin, heparin, aspirin, pentoxifylline, clopidogrel or ticlopidine.
- Patients taking ginko, garlic or vitamin E supplements.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2019
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT02276716
Start Date
November 1 2011
End Date
August 1 2019
Last Update
February 21 2021
Active Locations (1)
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1
NYU Langone Medical Center, Dyautonomia Center, Suite 9Q
New York, New York, United States, 10016