Norepinephrine Transporter Blockade as a Pathological Biomarker in Neurogenic Orthostatic Hypotension (6103)
|ClinicalTrials.gov Identifier: NCT01316666|
Recruitment Status : Completed
First Posted : March 16, 2011
Last Update Posted : January 6, 2017
|Condition or disease|
|Orthostatic Hypotension Pure Autonomic Failure Multiple System Atrophy Parkinson's Disease|
|Study Type :||Observational|
|Actual Enrollment :||50 participants|
|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|
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.
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|
|Rochester, Minnesota, United States, 55902|
|United States, New York|
|New York University|
|New York, New York, United States, 10016|
|United States, Tennessee|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator:||Italo Biaggioni, MD||Vanderbilt University|