- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00889135
Long Term Treatment With L-DOPS
October 14, 2016 updated by: David Robertson, Vanderbilt University
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 Overview
Status
Approved for marketing
Conditions
Intervention / Treatment
Study Type
Expanded Access
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tennessee
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Nashville, Tennessee, United States, 37232
- Vanderbilt University Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: David Robertson, M.D., Vanderbilt University Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2004
Primary Completion (Actual)
June 1, 2015
Study Completion (Actual)
June 1, 2015
Study Registration Dates
First Submitted
April 24, 2009
First Submitted That Met QC Criteria
April 24, 2009
First Posted (Estimate)
April 28, 2009
Study Record Updates
Last Update Posted (Estimate)
October 18, 2016
Last Update Submitted That Met QC Criteria
October 14, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 041037
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Dopamine Beta Hydroxylase (DBH) Deficiency
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Vanderbilt UniversityNational Heart, Lung, and Blood Institute (NHLBI)TerminatedAutonomic Nervous System Diseases | Orthostatic Hypotension | Orthostatic Intolerance | Dopamine Beta-Hydroxylase DeficiencyUnited States
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Vanderbilt University Medical CenterCompletedAutonomic Nervous System Diseases | Orthostatic Hypotension | Orthostatic Intolerance | Dopamine Beta-Hydroxylase DeficiencyUnited States
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Chelsea TherapeuticsCompletedNeurogenic Orthostatic Hypotension | Primary Autonomic Failure | Dopamine Beta Hydroxylase Deficiency | Non-Diabetic Neuropathy
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Chelsea TherapeuticsChiltern International Inc.CompletedPrimary Autonomic Failure | Dopamine Beta Hydroxylase Deficiency | Symptomatic Neurogenic Orthostatic Hypotension (NOH) | Non-diabetic NeuropathyUnited States, Australia, Canada, New Zealand
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Chelsea TherapeuticsChiltern International Inc.CompletedA Clinical Study for Patients With Neurogenic Orthostatic Hypotension (NOH) Using Droxidopa (NOH301)Primary Autonomic Failure | Dopamine Beta Hydroxylase Deficiency | Symptomatic Neurogenic Orthostatic Hypotension (NOH) | Non-diabetic NeuropathyUnited States, Canada
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Mayo ClinicRecruiting24-hydroxylase DeficiencyUnited States
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University Hospital, Basel, SwitzerlandCompletedHydroxylase Deficiency
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Chelsea TherapeuticsCompletedMultiple System Atrophy | Neurogenic Orthostatic Hypotension | Dopamine Beta Hydroxylase Deficiency | Non-Diabetic Autonomic NeuropathyUnited States, Australia, Canada, New Zealand
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Chelsea TherapeuticsTerminatedParkinson's Disease | Pure Autonomic Failure | Dopamine Beta Hydroxylase Deficiency | Symptomatic Neurogenic Orthostatic Hypotension | Multiple Systems AtrophyUnited States
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Orphanetics Pharma Entwicklungs GmbHTerminatedPhenylalanine Hydroxylase Deficiencies
Clinical Trials on droxidopa
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Icahn School of Medicine at Mount SinaiCompletedShy-Drager Syndrome | Orthostatic HypotensionUnited States
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Alberto Espay, MD, MScLundbeck LLCCompletedOrthostatic Hypotension | Idiopathic Parkinson DiseaseUnited States
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New York Medical CollegeLundbeck LLCActive, not recruitingPostural Tachycardia Syndrome (POTS) | Fainting | Vasovagal Syncope (VVS)United States
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H. Lundbeck A/SCompletedSymptomatic Neurogenic Orthostatic HypotensionUnited States
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Colorado Springs Neurological AssociatesH. Lundbeck A/SCompletedParkinson's DiseaseUnited States
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Chelsea TherapeuticsWithdrawnGait Disorders, NeurologicUnited States, Canada
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NYU Langone HealthWithdrawn
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University Hospital, ToulouseCompletedMultiple System AtrophyFrance
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Chelsea TherapeuticsCompletedMultiple System Atrophy | Neurogenic Orthostatic Hypotension | Dopamine Beta Hydroxylase Deficiency | Non-Diabetic Autonomic NeuropathyUnited States, Australia, Canada, New Zealand
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Vanderbilt UniversityNational Heart, Lung, and Blood Institute (NHLBI)TerminatedAutonomic Nervous System Diseases | Orthostatic Hypotension | Orthostatic Intolerance | Dopamine Beta-Hydroxylase DeficiencyUnited States