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Long Term Treatment With L-DOPS

This treatment has been approved for sale to the public.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00889135
First Posted: April 28, 2009
Last Update Posted: October 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
David Robertson, Vanderbilt University
  Purpose
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.

Condition Intervention
Dopamine Beta Hydroxylase (DBH) Deficiency Drug: droxidopa

Study Type: Expanded Access     What is Expanded Access?
Official Title: Long Term Treatment With L-DOPS

Resource links provided by NLM:


Further study details as provided by David Robertson, Vanderbilt University:

Study Start Date: September 2004
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: 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
    Other Names:
    • L-DOPS
    • DOPS
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00889135


Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: David Robertson, M.D. Vanderbilt University Medical Center
  More Information

Responsible Party: David Robertson, Professor of Medicine and Pharmacology, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00889135     History of Changes
Other Study ID Numbers: 041037
First Submitted: April 24, 2009
First Posted: April 28, 2009
Last Update Posted: October 18, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Droxidopa
Antiparkinson Agents
Anti-Dyskinesia Agents