Open-Label Clinical Study of Droxidopa in Patients With Neurogenic Orthostatic Hypotension (NOH)

Completed · Phase 3 · Has a placebo group

Conditions studied: Neurogenic Orthostatic Hypotension, Non-Diabetic Autonomic Neuropathy, Multiple System Atrophy, Dopamine Beta Hydroxylase Deficiency

In brief

The purpose of this study is to assess the durability of effect of Droxidopa 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.

Key facts

Study ID

NCT00738062

Run by

Chelsea Therapeutics

People needed

103

Starts

2008-01-01

Expected to finish

2010-12-01

Last updated by the study team

2014-05-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• To be eligible for inclusion, each patient must fulfill the following criteria:
• Participated in Droxidopa Protocol 302;
• Provide written informed consent to participate in the study and understand that they may withdraw their consent at any time without prejudice to their future medical care.

You may not qualify if…

• Patients are not eligible for this study if they fulfill one or more of the following criteria:
• Currently taking ephedrine or midodrine;
• Patients taking ephedrine or midodrine must stop taking these drugs at least 2 days prior to their study entry visit (Visit 1).
• Currently taking anti-hypertensive medication;
• The use of short-acting anti-hypertensive medications at bedtime is permitted.
• Currently taking tri-cyclic antidepressant medication or other norepinephrine re-uptake inhibitors;
• Have changed dose, frequency and or type of prescribed medication, within two weeks of study start (excluding ephedrine and midodrine);
• History of more than moderate alcohol consumption;
• History of known or suspected drug or substance abuse;
• Women of childbearing potential who are not using a medically accepted contraception;
• Reproductive potential:
• Female subjects should be either post-menopausal (amenorrhea for at least 12 consecutive months), surgically sterile, or women of child-bearing potential (WOCP) who are using or agree to use acceptable methods of contraception.
• Acceptable contraceptives include intrauterine devices (IUDs), hormonal contraceptives (oral, depot, patch or injectable) and double barrier methods such as condoms or diaphragms with spermicidal gel or foam.
• For WOCP a urine pregnancy test must be conducted at each study visit.
• WOCP must be advised to use acceptable contraceptives throughout the study period and for 30 days after the last dose of investigational product.
• If hormonal contraceptives are used they should be taken according to the package insert.
• WOCP who are not currently sexually active must agree to use acceptable contraception, as defined above, if they decide to become sexually active during the period of the study and for 30 days after the last dose of investigational product.
• Sexually active males whose partner is a WOCP and who do not agree to use condoms for the duration of the study and for 30 days after the last dose;
• Women who are pregnant or breast feeding;
• Known or suspected hypersensitivity to the study medication or any of its ingredients;
• Pre-existing sustained severe hypertension (BP 180/110 mmHg in the sitting position);
• Have atrial fibrillation or, in the investigator's opinion, have any other significant cardiac arrhythmia;
• Any other significant systemic, hepatic, cardiac or renal illness;
• Diabetes mellitus or insipidus;
• Have a history of closed angle glaucoma;

Where it is running

• Dedicated Clinical Research — Litchfield Park, Arizona, United States
• Xenoscience Inc. — Phoenix, Arizona, United States
• Sun Health Research Institute — Sun City, Arizona, United States
• The Parkinson's and Movement Disorders Institute — Fountain Valley, California, United States
• Pacific Neuroscience Medical Group — Oxnard, California, United States
• The Parkinson's Institute — Sunnyvale, California, United States
• Electrophysiology Associates — Colorado Springs, Colorado, United States
• Parkinson's Disease & Movment Disorder Center — Boca Raton, Florida, United States
• Southeastern Integrated Medical — Gainesville, Florida, United States
• Mayo Jacksonville Florida Department of Neurology — Jacksonville, Florida, United States
• University of Miami Miller School of Medicine — Miami, Florida, United States
• University of South Florida — Tampa, Florida, United States
• Medical Associates of North Georgia — Canton, Georgia, United States
• Saint Mary of Nazareth Hospital Center — Chicago, Illinois, United States
• North Chicago VA Medical Center — North Chicago, Illinois, United States
• Indiana Medical Research — Elkhart, Indiana, United States
• JWM Neurology — Indianapolis, Indiana, United States
• Kansas City Bone and Joint, PA — Overland Park, Kansas, United States
• University of Louisville — Louisville, Kentucky, United States
• University of Maryland Hospital — Baltimore, Maryland, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• University of Massachusetts Worcester — Worcester, Massachusetts, United States
• Henry Ford Health System — Southfield, Michigan, United States
• Mayo Clinic Rochester — Rochester, Minnesota, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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