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Generated: February 23, 2019

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CLINICAL TRIALS PROFILE FOR DROXIDOPA

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Clinical Trials for Droxidopa

Trial ID Title Status Sponsor Phase Summary
NCT00004478 Droxidopa in Treating Patients With Neurogenic Hypotension Completed Icahn School of Medicine at Mount Sinai N/A Please note that the continuation study can be found at http://clinicaltrials.gov/show/NCT00633880. RATIONALE: Neurogenic hypotension is a fall in blood pressure that occurs when one moves from a lying down to a standing position or after eating a meal. It causes one to feel dizzy, light headed, and weak. Neurogenic hypotension is caused by a problem in the part of the nervous system that controls such functions as heart rate and blood pressure. Droxidopa, a drug that may increase blood pressure, may be an effective treatment for neurogenic hypotension. PURPOSE: Clinical trial to study the effectiveness of droxidopa in treating patients who have neurogenic hypotension.
NCT00547911 Augmenting Effects of L-DOPS With Carbidopa and Entacapone Terminated National Institute of Neurological Disorders and Stroke (NINDS) Phase 1/Phase 2 An experimental drug called L-DOPS increases production in the body of a messenger chemical called norepinephrine. Cells in the brain that make norepinephrine are often gone in Parkinson disease. The exact consequences of this loss are unknown, but they may be related to symptoms such as fatigue, depression, or decreased attention that occur commonly in Parkinson disease. This study will explore effects of L-DOPS in conjunction with carbidopa and entacapone, which are drugs used to treat Parkinson disease. We wish to find out what the effects are of increasing norepinephrine production in the brain and whether carbidopa and entacapone augment those effects. Volunteers for this study must be at least 18 years of age and able to give consent to participate in the study. To participate in the study, volunteers must discontinue use of alcohol, tobacco, and certain herbal medicines or dietary supplements, and must also taper or discontinue certain kinds of medications that might interfere with the results of the study. Candidates will be screened with a medical history and physical exam. Participants will be admitted to the National Institutes of Health Clinical Center for two weeks of testing. The study will have three testing phases in a randomly chosen order for each participant: - Single dose of L-DOPS - Single dose of L-DOPS in conjunction with carbidopa - Single dose of L-DOPS in conjunction with entacapone Each phase will last two days, with a washout day between each phase in which no drugs will be given and no testing will be performed. In each phase, participants will undergo a series of tests and measurements, including blood pressure and electrocardiogram tests. Participants who are healthy volunteers will also have blood drawn and will undergo a lumbar puncture (also known as a spinal tap) to obtain spinal fluid for chemical tests.
NCT00581477 Treatment of Orthostatic Hypotension Enrolling by invitation Vanderbilt University Medical Center Phase 3 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.
NCT00633880 Clinical Study of Droxidopa in Patients With Neurogenic Orthostatic Hypotension (NOH) Completed Chiltern International Inc. Phase 3 The purpose of this study is to see whether droxidopa is effective in treating symptoms of neurogenic orthostatic hypotension in patients with Primary Autonomic Failure (Pure Autonomic Failure, Multiple System Atrophy, Parkinson's Disease), Non-diabetic neuropathy, or Beta Hydroxylase deficiency.
NCT00633880 Clinical Study of Droxidopa in Patients With Neurogenic Orthostatic Hypotension (NOH) Completed Chelsea Therapeutics Phase 3 The purpose of this study is to see whether droxidopa is effective in treating symptoms of neurogenic orthostatic hypotension in patients with Primary Autonomic Failure (Pure Autonomic Failure, Multiple System Atrophy, Parkinson's Disease), Non-diabetic neuropathy, or Beta Hydroxylase deficiency.
NCT00657046 Safety and Benefit Study of Droxidopa to Treat Patients With Intradialytic Hypotension Completed Chelsea Therapeutics Phase 2 In clinical trials in Japan, droxidopa has been shown to be effective in affecting blood pressure changes upon orthostatic challenge in patients with autonomic dysfunction, as well as reducing the severity and frequency of symptoms of orthostatic hypotension in these patients. The efficacy of droxidopa in ameliorating symptoms in patients undergoing dialysis has also been demonstrated in the literature and clinical trials conducted in Japan. The current study will investigate the clinical efficacy of two different doses of droxidopa in patients with intradialytic hypotension over a 4 week treatment period with a placebo control. The clinical efficacy will be evaluated by changes in hypotension- related symptoms, as well as changes in blood pressure prior to, during and following, HD sessions as compared to their pre-treatment baseline values.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Droxidopa

Condition Name

Condition Name for Droxidopa
Intervention Trials
Orthostatic Hypotension 7
Parkinson Disease 6
Multiple System Atrophy 5
Dopamine Beta Hydroxylase Deficiency 5
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Condition MeSH

Condition MeSH for Droxidopa
Intervention Trials
Hypotension 21
Hypotension, Orthostatic 18
Parkinson Disease 11
Autonomic Nervous System Diseases 7
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Clinical Trial Locations for Droxidopa

Trials by Country

Trials by Country for Droxidopa
Location Trials
United States 126
Canada 12
Australia 6
New Zealand 4
Taiwan 1
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Trials by US State

Trials by US State for Droxidopa
Location Trials
New York 12
Tennessee 8
Texas 7
Michigan 6
California 6
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Clinical Trial Progress for Droxidopa

Clinical Trial Phase

Clinical Trial Phase for Droxidopa
Clinical Trial Phase Trials
Phase 4 4
Phase 3 8
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Droxidopa
Clinical Trial Phase Trials
Completed 12
Recruiting 10
Terminated 4
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Clinical Trial Sponsors for Droxidopa

Sponsor Name

Sponsor Name for Droxidopa
Sponsor Trials
Chelsea Therapeutics 15
H. Lundbeck A/S 4
Vanderbilt University Medical Center 3
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Sponsor Type

Sponsor Type for Droxidopa
Sponsor Trials
Industry 25
Other 17
U.S. Fed 3
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