Official Title: “Treatment of Hypotensive Patients Having a Unique Pattern of Autonomic Symptoms”

The purpose of this study is to try different medications in patients with low blood pressure and other problems with their involuntary (autonomic) nervous system. The pharmacological trials in this study will perhaps lead to more effective treatment. This study consists of single dose trials, dose selection trials, 5-day trials and chronic (approximately 2 months) trials.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Single Blind (Subject), Placebo Control, Crossover Assignment, Efficacy Study

Study Primary Completion Date: December 2010

We see many patients at the Autonomic Dysfunction Center who can be given a fairly definitive diagnosis, e.g., Orthostatic Intolerance, Pure Autonomic Failure, Multiple System Atrophy, and Baroreflex Failure. However, some patients present with a unique constellation of symptoms of autonomic dysfunction so that they do not fit into a diagnostic category. We hypothesize that a genetic cause exists in some of these patients. We further propose that our comprehensive evaluation of these patients will provide us with information on the pathophysiology of their condition and assist us in optimizing their treatment.

Intervention(s) in this Clinical Trial

• Drug: droxidopa
  • up to 300mg four times daily
• Drug: placebo
  • same frequency as experimental medication
• Drug: alpha-methyldopa
  • up to 250mg two times daily
• Drug: carbidopa
  • up to 25mg four times daily
• Drug: metyrosine
  • up to 1000mg three times daily
• Drug: levodopa
  • up to 250mg three times daily
• Drug: atomoxetine
  • up to 40mg twice daily
• Drug: metoclopramide
  • up to 10mg four times daily

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: 2
• Experimental: 1

Primary Measures

• Change in blood pressure with standing
  • Time Frame: following 5 days of medication
    Safety Issue?: No

Secondary Measures

• length of time subject is able to stand
  • Time Frame: following 5 days of medication
    Safety Issue?: No

Inclusion Criteria:

• patients with severe orthostatic hypotension and other autonomic symptoms who do not meet criteria for one of our standard diagnoses
• non-smokers
• drug-free
• able to give informed consent
• free of pulmonary, renal, hematopoietic, hepatic and cardiac disease

Exclusion Criteria:

• medications affecting the autonomic nervous system
• any chronic illness (cardiac, pulmonary, endocrine, gastrointestinal, rheumatologic)
• anemia (Hct < 30)
• women of childbearing age who are pregnant or nursing
• smokers

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Vanderbilt University

Overall Clinical Trial Officials and Contacts

David Robertson, MD Principal Investigator Vanderbilt University  

Overall Contact: Bonnie K Black, RN  adc.research@vanderbilt.edu

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00581477

Study ID Number: 030750

ClinicalTrials.gov Identifier: NCT00581477

Health Authority: United States: Food and Drug Administration

Autonomic Dysfunction Center Website