Phase II Study of Midodrine for Neurogenic Orthostatic Hypotension
Phase II Study of Midodrine for Neurogenic Orthostatic Hypotension
OBJECTIVES: I. Study further the safety and efficacy of the alpha-receptor agonist midodrine
 in patients with neurogenic orthostatic hypotension.

 II. Assess the quality of life in these patients with this treatment regimen.
PROTOCOL OUTLINE: This is a partially randomized, multicenter study. Patients receive oral
 midodrine three times a day during weeks 1 and 3-5, then either oral midodrine or placebo for
 weeks 6-8.

 Quality of life is assessed at weeks 3, 6, and 8.
PROTOCOL ENTRY CRITERIA:

 --Disease Characteristics-- Orthostatic hypotension due to autonomic nervous system
 failure, i.e.: Fall in systolic blood pressure (supine to standing) of at least 15 mm Hg
 AND Symptoms of dizziness, lightheadedness, unsteadiness with a severity of 4.5 or less on
 a 10 point scale in 2 of 3 evaluations over a 3 day period --Prior/Concurrent Therapy-- No
 concurrent sympathomimetics or alpha-receptor agonists or antagonists No concurrent drug
 with significant smooth muscle relaxant or constrictive properties e.g., calcium channel
 blockers At least 30 days since other prior investigational agents --Patient
 Characteristics-- Hepatic: No coagulopathy Renal: No acute nephritis or chronic renal
 failure Cardiovascular: No sustained supine hypertension greater than 180/110 mm Hg No
 congestive heart failure No myocardial infarction within the last 6 months No uncontrolled
 arrhythmia (ventricular tachycardia or second or third degree heart block not treated with
 pacemaker) No unstable angina pectoris No history of cerebral vascular accident Other: No
 pheochromocytoma No thyrotoxicosis No seizure disorder Not pregnant or nursing Negative
 pregnancy test Fertile patients must use effective contraception