Phase
Condition
Dizzy/fainting Spells
Circulation Disorders
Multiple System Atrophy
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: 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 theymay withdraw their consent at any time without prejudice to their future medical care.
Exclusion
Exclusion Criteria: Patients are not eligible for this study if they fulfill one or more of the followingcriteria:
Currently taking ephedrine or midodrine;
Patients taking ephedrine or midodrine must stop taking these drugs at least 2 daysprior 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 norepinephrinere-uptake inhibitors;
Have changed dose, frequency and or type of prescribed medication, within two weeks ofstudy 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 12consecutive 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), hormonalcontraceptives (oral, depot, patch or injectable) and double barrier methods suchas 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 periodand for 30 days after the last dose of investigational product.
If hormonal contraceptives are used they should be taken according to the packageinsert.
WOCP who are not currently sexually active must agree to use acceptablecontraception, as defined above, if they decide to become sexually active duringthe period of the study and for 30 days after the last dose of investigationalproduct.
Sexually active males whose partner is a WOCP and who do not agree to use condoms forthe 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 significantcardiac 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 umol/L;
Patients with known gastrointestinal illness or other gastrointestinal disorder thatmay, in the investigator's opinion, affect the absorption of study drug;
In the investigator's opinion, have clinically significant abnormalities on clinicalexamination or laboratory testing;
In the investigator's opinion, are unable to adequately co-operate because ofindividual or family situation;
In the investigator's opinion, are suffering from a mental disorder that interfereswith the diagnosis and/or with the conduct of the study, e.g. schizophrenia, majordepression, dementia;
Are not able or willing to comply with the study requirements for the duration of thestudy.
Study Design
Study Description
Connect with a study center
Royal Adelaide Hospital
Adelaide, South Australia 5000
AustraliaSite Not Available
Baker Heart Research Institute
Melbourne, Victoria 3004
AustraliaSite Not Available
Austin Hospital
Heidelburg, 3084
AustraliaSite Not Available
McMaster University
Hamilton, Ontario L8L2X2
CanadaSite Not Available
Centre for Movement Disorders
Markham, Ontario L6B1C9
CanadaSite Not Available
Parkinson's & Neurodegenerative Disorders Clinic
Ottawa, Ontario K1G4G3
CanadaSite Not Available
SMBD Jewish General Hospital - Department of Neurology
Montreal, Quebec H3T 1E2
CanadaSite Not Available
Quebec Memory and Motor Skills Disorders Clinic
Quebec, G1R 3X5
CanadaSite Not Available
Auckland Hospital
Grafton Auckland, Private Bag
New ZealandSite Not Available
Van der Veer Institute for Parkinson's Disease and Movement Disorders
Christchurch,
New ZealandSite Not Available
University of Alabama at Birmingham
Birmingham, Alabama 35233
United StatesSite Not Available
Dedicated Clinical Research
Litchfield Park, Arizona 85340
United StatesSite Not Available
Xenoscience Inc.
Phoenix, Arizona 85004
United StatesSite Not Available
Sun Health Research Institute
Sun City, Arizona 85351
United StatesSite Not Available
The Parkinson's and Movement Disorders Institute
Fountain Valley, California 92708
United StatesSite Not Available
Pacific Neuroscience Medical Group
Oxnard, California 93030
United StatesSite Not Available
The Parkinson's Institute
Sunnyvale, California 94085
United StatesSite Not Available
Electrophysiology Associates
Colorado Springs, Colorado 80910
United StatesSite Not Available
Parkinson's Disease & Movment Disorder Center
Boca Raton, Florida 33486
United StatesSite Not Available
Southeastern Integrated Medical
Gainesville, Florida 32607
United StatesSite Not Available
Mayo Jacksonville Florida Department of Neurology
Jacksonville, Florida 32224
United StatesSite Not Available
University of Miami Miller School of Medicine
Miami, Florida 33136
United StatesSite Not Available
University of South Florida
Tampa, Florida 33606
United StatesSite Not Available
Medical Associates of North Georgia
Canton, Georgia 30114
United StatesSite Not Available
Saint Mary of Nazareth Hospital Center
Chicago, Illinois 60622
United StatesSite Not Available
North Chicago VA Medical Center
North Chicago, Illinois 60064
United StatesSite Not Available
Indiana Medical Research
Elkhart, Indiana 46514
United StatesSite Not Available
JWM Neurology
Indianapolis, Indiana 46237
United StatesSite Not Available
Kansas City Bone and Joint, PA
Overland Park, Kansas 66211
United StatesSite Not Available
University of Louisville
Louisville, Kentucky 40202
United StatesSite Not Available
University of Maryland Hospital
Baltimore, Maryland 21201
United StatesSite Not Available
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
United StatesSite Not Available
University of Massachusetts Worcester
Worcester, Massachusetts 01655
United StatesSite Not Available
Henry Ford Health System
Southfield, Michigan 48034
United StatesSite Not Available
Mayo Clinic Rochester
Rochester, Minnesota 55905
United StatesSite Not Available
Washington University Medical Center
St. Louis, Missouri 63110
United StatesSite Not Available
New Jersey Neuroscience Institute
Edison, New Jersey 08818
United StatesSite Not Available
Kingston Neurological Associates, PC
Kingston, New York 12401
United StatesSite Not Available
Columbia University Neurological institute of NY
New York, New York 10032
United StatesSite Not Available
NYU Medical Center
New York City, New York 10016
United StatesSite Not Available
University of Rochester
Rochester, New York 14618
United StatesSite Not Available
Duke University Medical Center
Durham, North Carolina 27705
United StatesSite Not Available
Wake Forest University
Winston Salem, North Carolina 27157
United StatesSite Not Available
University of Cincinnati
Cincinnati, Ohio 45267
United StatesSite Not Available
Cleveland Clinic
Cleveland, Ohio 44195
United StatesSite Not Available
University Hospitals Case Medical Center
Cleveland, Ohio 44106
United StatesSite Not Available
COR Clinical Research, LLC
Oklahoma City, Oklahoma 73103
United StatesSite Not Available
The Oregon Clinic
Portland, Oregon 97213
United StatesSite Not Available
Vanderbilt University
Nashville, Tennessee 37212
United StatesSite Not Available
Jacinto Medical Group, PA
Baytown, Texas 77521
United StatesSite Not Available
UT Southwestern Medical Center
Dallas, Texas 75390-9036
United StatesSite Not Available
Scott & White Healthcare - Round Rock
Round Rock, Texas 78665
United StatesSite Not Available
Scott & White Memorial Hospital & Clinic
Temple, Texas 76508
United StatesSite Not Available
East Texas Medical Center - Neurological Institute Movment Disorders Center
Tyler, Texas 75701
United StatesSite Not Available
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