Norepinephrine Transporter Blockade as a Pathological Biomarker in Neurogenic Orthostatic Hypotension (6103)
![]() |
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. |
ClinicalTrials.gov Identifier: NCT01316666 |
Recruitment Status :
Completed
First Posted : March 16, 2011
Last Update Posted : January 6, 2017
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease |
---|
Orthostatic Hypotension Pure Autonomic Failure Multiple System Atrophy Parkinson's Disease |
Study Type : | Observational |
Actual Enrollment : | 50 participants |
Time Perspective: | Prospective |
Official Title: | Norepinephrine Transporter Blockade as a Pathophysiological Biomarker in Neurogenic Orthostatic Hypotension |
Study Start Date : | March 2011 |
Actual Primary Completion Date : | December 2016 |
Actual Study Completion Date : | December 2016 |

Group/Cohort |
---|
Neurogenic Hypotension
Patients with neurogenic hypotension, which includes those with Pure Autonomic Failure (PAF), Multiple System Atrophy (MSA) and Parkinson Disease (PD)
|
- Final Diagnosis (pre vs post ganglionic autonomic failure) based on clinical criteria. [ Time Frame: 3 years ]
Probable MSA - PAF with urinary incontinence or an orthostatic decrease of 30 mmHG in systolic blood pressure within 3 minutes of standing and poorly levodopa responsive parkinsonism or a cerebellar syndome.
For Possible MSA - parkinsonism or a cerebellar syndrome and one additional feature.
Probable PAF - orthostatic hypotension and impaired autonomic reflexes in the absence of clinical signs or symptoms of neurodegeneration.
For Parkinson's Disease: diagnosed based on the United Kingdom Parkinson Disease Society Brain Bank clinical diagnostic criteria.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- Age 18-80 years old with Neurogenic orthostatic hypotension, ≥30 mmHg drop in SBP within 5 minutes of standing
- Associated with impaired autonomic reflexes, as determined by absence of blood pressure overshoot during phase IV of the Valsalva maneuver
- Absence of other identifiable causes of autonomic neuropathy
- Able and willing to provide informed consent
Exclusion Criteria:
- Pregnancy
- Systemic illnesses known to produce autonomic neuropathy, including but not limited to diabetes mellitus, amyloidosis, monoclonal gammopathy of unknown significance, and autoimmune neuropathies
- Known intolerance to atomoxetine, Pre-existing sustained severe hypertension (BP at least 180/110 mmHg in the sitting position)
- Clinically unstable coronary artery disease, or major cardiovascular or neurological event in the past 6 months
- Any other significant systemic, hepatic, cardiac or renal illness
- Use of MAO-I within 14 days
- Known closed-angle glaucoma or Life-threatening arrhythmias

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): NCT01316666
United States, Massachusetts | |
Beth Israel Deaconess Medical Center (Harvard) | |
Boston, Massachusetts, United States, 02215 | |
United States, Minnesota | |
Mayo Clinic | |
Rochester, Minnesota, United States, 55902 | |
United States, New York | |
New York University | |
New York, New York, United States, 10016 | |
United States, Tennessee | |
Vanderbilt University | |
Nashville, Tennessee, United States, 37232 |
Principal Investigator: | Italo Biaggioni, MD | Vanderbilt University |
Publications:
Responsible Party: | Italo Biaggioni, MD, Vanderbilt University |
ClinicalTrials.gov Identifier: | NCT01316666 |
Other Study ID Numbers: |
101311 U54NS065736 ( U.S. NIH Grant/Contract ) |
First Posted: | March 16, 2011 Key Record Dates |
Last Update Posted: | January 6, 2017 |
Last Verified: | January 2017 |
orthostatic hypotension Multiple System Atrophy Pure Autonomic Failure Parkinson's Disease |
Parkinson Disease Multiple System Atrophy Shy-Drager Syndrome Hypotension, Orthostatic Pure Autonomic Failure Hypotension Atrophy Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Movement Disorders Synucleinopathies Neurodegenerative Diseases Pathological Conditions, Anatomical Vascular Diseases Cardiovascular Diseases Primary Dysautonomias Autonomic Nervous System Diseases Orthostatic Intolerance |