Dopamine Beta Hydroxylase (DBH) Deficiency Clinical Trial
Official title:
Long Term Treatment With L-DOPS
| Verified date | October 2016 |
| Source | Vanderbilt University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Expanded Access |
This study is designed to supply L-DOPS (droxidopa) on a long term basis to patients with a genetic form of profound orthostatic hypotension, most commonly DBH deficiency. It also allows us to collect medical history information on this small population of patients that would allow us to determine if there are any complications from this type of treatment.
| Status | Approved for marketing |
| Enrollment | 0 |
| Est. completion date | June 2015 |
| Est. primary completion date | June 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - 18 years old or older with orthostatic hypotension - established diagnosis of DBH deficiency and fractionated plasma catecholamine levels that show high dopamine levels and very low norepinephrine and epinephrine levels. Blood pressure increase in response to oral treatment with L-DOPS during previous studies. Exclusion Criteria: - subjects with orthostatic hypotension that do not have a genetic form of the disorder and catecholamine pattern is not consistent with that above. |
N/A
| Country | Name | City | State |
|---|---|---|---|
| United States | Vanderbilt University Medical Center | Nashville | Tennessee |
| Lead Sponsor | Collaborator |
|---|---|
| Vanderbilt University |
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