Long Term Treatment With L-DOPS

N/AApproved For MarketingNCT00889135

Vanderbilt University

Overview

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.

Study Type

EXPANDED_ACCESS

Conditions

Dopamine Beta Hydroxylase (DBH) Deficiency

Interventions

droxidopaDRUG

Droxidopa (L-DOPS) comes in capsule form, 100 mg or 200 mg strength and is usually administered 2 - 3 times per day. It would be taken indefinitely to improve symptoms of orthostatic hypotension

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Data from ClinicalTrials.gov

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