Phase III, Multi-Center, Study to Assess the Clinical Effect of Droxidopa in Subjects With Primary Autonomic Failure, Dopamine Beta Hydroxylase Deficiency or Non-Diabetic Neuropathy and Symptomatic NOH

Status: Completed
Location: See all (54) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• 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.

Locations
United States
Alabama
University of Alabama at Birmingham
Birmingham
Arizona
Dedicated Clinical Research
Litchfield Park
Xenoscience Inc.
Phoenix
Sun Health Research Institute
Sun City
California
The Parkinson's and Movement Disorders Institute
Fountain Valley
Pacific Neuroscience Medical Group
Oxnard
The Parkinson's Institute
Sunnyvale
Colorado
Electrophysiology Associates
Colorado Springs
Florida
Parkinson's Disease & Movment Disorder Center
Boca Raton
Southeastern Integrated Medical
Gainesville
Mayo Jacksonville Florida Department of Neurology
Jacksonville
University of Miami
Miami
University of South Florida
Tampa
Georgia
Medical Associates of North Georgia
Canton
Illinois
Saint Mary of Nazareth Hospital Center
Chicago
North Chicago VA Medical Center
North Chicago
Indiana
Indiana Medical Research
Elkhart
JWM Neurology
Indianapolis
Kansas
Kansas City Bone and Joint, PA
Overland Park
Kentucky
University of Louisville
Louisville
Massachusetts
Beth Israel Deaconess Medical Center
Boston
University of Massachusetts Worcester
Worcester
Maryland
University of Maryland
Baltimore
Michigan
Henry Ford Health System
Southfield
Minnesota
Mayo Clinic Rochester
Rochester
Missouri
Washington University Medical Center
St. Louis
North Carolina
Duke University Medical Center
Durham
Wake Forest University
Winston Salem
New Jersey
New Jersey Neuroscience Institute
Edison
New York
Kingston Neurological Associates, PC
Kingston
Columbia University
New York
NYU Medical Center
New York City
University of Rochester
Rochester
Ohio
University of Cincinnati
Cincinnati
Cleveland Clinic
Cleveland
University Hospitals Case Medical Center
Cleveland
Oklahoma
COR Clinical Research, LLC
Oklahoma City
Oregon
The Oregon Clinic
Portland
Tennessee
Vanderbilt University
Nashville
Texas
Jacinto Medical Group, PA
Baytown
UT Southwestern Medical Center
Dallas
Scott & White Healthcare - Round Rock
Round Rock
Scott & White Memorial Hospital & Clinic
Temple
East Texas Medical Center
Tyler
Other Locations
Australia
Royal Adelaide Hospital
Adelaide
Austin Hospital
Heidelburg
Baker Heart Research Institute
Melbourne
Canada
McMaster University
Hamilton
Centre for Movement Disorders
Markham
SMBD Jewish General Hospital
Montreal
Parkinson's & Neurodegenerative Disorders Clinic
Ottawa
Quebec Memory and Motor Skills Disorders Clinic
Quebec
New Zealand
Van der Veer Institute for Parkinson's Disease and Movement Disorders
Christchurch
Auckland Hospital
Grafton Auckland
Time Frame
Start Date: January 2008
Completion Date: September 2009
Participants
Target number of participants: 181
Treatments
Experimental: Droxidopa
Double-blind
Placebo Comparator: Placebo
Double-blind
Sponsors
Collaborators: Chiltern International Inc.
Leads: Chelsea Therapeutics

This content was sourced from clinicaltrials.gov

Similar Clinical Trials