Long Term Treatment With L-DOPS

NCT ID: NCT00889135

Last Updated: 2016-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

APPROVED_FOR_MARKETING

Study Classification

EXPANDED_ACCESS

Study Start Date

2004-09-30

Study Completion Date

2015-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Dopamine Beta Hydroxylase (DBH) Deficiency

Interventions

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droxidopa

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

Intervention Type DRUG

Other Intervention Names

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L-DOPS DOPS

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vanderbilt University

OTHER

Sponsor Role lead

Responsible Party

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David Robertson

Professor of Medicine and Pharmacology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David Robertson, M.D.

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

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Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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041037

Identifier Type: -

Identifier Source: org_study_id

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