A Clinical Study for Patients With Neurogenic Orthostatic Hypotension (NOH) Using Droxidopa

Completed · Phase 3 · Has a placebo group

Conditions studied: Symptomatic Neurogenic Orthostatic Hypotension (NOH), Non-diabetic Neuropathy, Primary Autonomic Failure, Dopamine Beta Hydroxylase Deficiency

In brief

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.

Key facts

Study ID: NCT00782340
Run by: Chelsea Therapeutics
People needed: 263
Starts: 2008-09-01
Expected to finish: 2010-09-01
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:
Male or female and aged 18 years or over
Clinical diagnosis of orthostatic hypotension associated with Primary Autonomic Failure (PD, MSA and PAF), Dopamine Beta Hydroxylase Deficiency or Non-Diabetic Autonomic Neuropathies
A documented fall in systolic blood pressure of at least 20 mmHg, or in diastolic blood pressure of at least 10 mmHg, within 3 minutes after standing;
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…

Currently taking ephedrine or midodrine
Patients taking ephedrine or midodrine must stop taking these drugs at least 2 days prior to their baseline visit (Visit 2).
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
For WOCP a serum beta HCG pregnancy test must be conducted at screening, and a urine pregnancy test must be conducted at baseline and study termination; the results must be negative at screening and at baseline for the patient to receive study medication.
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
Have a known or suspected malignancy
Have a serum creatinine level > 130 mmol/L
Patients with known gastrointestinal illness or other gastrointestinal disorder that may, in the investigator's opinion, affect the absorption of study drug
In the investigator's opinion, have clinically significant abnormalities on clinical examination or laboratory testing
In the investigator's opinion, are unable to adequately co-operate because of individual or family situation
In the investigator's opinion, are suffering from a mental disorder that interferes with the diagnosis and/or with the conduct of the study, e.g. schizophrenia, major depression, dementia
Are not able or willing to comply with the study requirements for the duration of the study
Have participated in another clinical trial with an investigational agent (including named patient or compassionate use protocol) within 4 weeks before the start of the study

Where it is running

North Alabama Neuroscience — Huntsville, Alabama, United States
Mayo Clinic-Arizona — Scottsdale, Arizona, United States
Arkansas Cardiology — Little Rock, Arkansas, United States
University of California, Irvine — Irvine, California, United States
Bradenton Neurology, Inc — Bradenton, Florida, United States
Suncoast Neuroscience Associates, Inc — St. Petersburg, Florida, United States
University of Kansas Medical Center — Kansas City, Kansas, United States
Cncs, Ninds,Nih — Bethesda, Maryland, United States
Nerological Reserch Center at Hattiesburg — Hattiesburg, Mississippi, United States
North Shore Hospital — Manshasette, New York, United States
Pennsylvania Hospital of the University of PA Health System- Department of Neurology — Philadelphia, Pennsylvania, United States
HAN Neurological Associates — Upland, Pennsylvania, United States
Baylor College of Medicine — Houston, Texas, United States
Evergreen Hospital Medical Center; Booth Gardner Parkinson's Care Center — Kirkland, Washington, United States
University of Calgary — Calgary, Alberta, Canada
University of Alberta — Edmonton, Alberta, Canada
Movment Disorder Clinic Deer lodge Centre — Winnipeg, Manitoba, Canada
David B. King, - Private Clinic — Halifax, Nova Scotia, Canada
London Health Sciences Centre, UH — London, Ontario, Canada
UHNresearch — Toronto, Ontario, Canada
IRCM — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.