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

PHASE3CompletedINTERVENTIONAL
Enrollment

181

Participants

Timeline

Start Date

January 31, 2008

Primary Completion Date

August 31, 2009

Study Completion Date

September 30, 2009

Conditions
Symptomatic Neurogenic Orthostatic Hypotension (NOH)Non-diabetic NeuropathyPrimary Autonomic FailureDopamine Beta Hydroxylase Deficiency
Interventions
DRUG

Placebo

100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day

DRUG

Droxidopa

100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day

Trial Locations (54)

3004

Baker Heart Research Institute, Melbourne

3084

Austin Hospital, Heidelburg

5000

Royal Adelaide Hospital, Adelaide

10016

NYU Medical Center, New York

10032

Columbia University, New York

12401

Kingston Neurological Associates, PC, Kingston

14618

University of Rochester, Rochester

21201

University of Maryland, Baltimore

27157

Wake Forest University, Winston-Salem

27705

Duke University Medical Center, Durham

30114

Medical Associates of North Georgia, Canton

32224

Mayo Jacksonville Florida Department of Neurology, Jacksonville

32607

Southeastern Integrated Medical, Gainesville

33136

University of Miami, Miami

33486

Parkinson's Disease & Movment Disorder Center, Boca Raton

33606

University of South Florida, Tampa

35233

University of Alabama at Birmingham, Birmingham

37212

Vanderbilt University, Nashville

40202

University of Louisville, Louisville

44106

University Hospitals Case Medical Center, Cleveland

44195

Cleveland Clinic, Cleveland

45267

University of Cincinnati, Cincinnati

46237

JWM Neurology, Indianapolis

46514

Indiana Medical Research, Elkhart

48034

Henry Ford Health System, Southfield

55905

Mayo Clinic Rochester, Rochester

60064

North Chicago VA Medical Center, North Chicago

60622

Saint Mary of Nazareth Hospital Center, Chicago

63110

Washington University Medical Center, St Louis

66211

Kansas City Bone and Joint, PA, Overland Park

73103

COR Clinical Research, LLC, Oklahoma City

75701

East Texas Medical Center, Tyler

76508

Scott & White Memorial Hospital & Clinic, Temple

77521

Jacinto Medical Group, PA, Baytown

78665

Scott & White Healthcare - Round Rock, Round Rock

80910

Electrophysiology Associates, Colorado Springs

85004

Xenoscience Inc., Phoenix

85340

Dedicated Clinical Research, Litchfield Park

85351

Sun Health Research Institute, Sun City

92708

The Parkinson's and Movement Disorders Institute, Fountain Valley

93030

Pacific Neuroscience Medical Group, Oxnard

94085

The Parkinson's Institute, Sunnyvale

97213

The Oregon Clinic, Portland

02215

Beth Israel Deaconess Medical Center, Boston

01655

University of Massachusetts Worcester, Worcester

08818

New Jersey Neuroscience Institute, Edison

75390-9036

UT Southwestern Medical Center, Dallas

L8L2X2

McMaster University, Hamilton

L6B1C9

Centre for Movement Disorders, Markham

K1G4G3

Parkinson's & Neurodegenerative Disorders Clinic, Ottawa

H3T 1E2

SMBD Jewish General Hospital, Montreal

G1R 3X5

Quebec Memory and Motor Skills Disorders Clinic, Québec

Unknown

Auckland Hospital, Grafton Auckland

Van der Veer Institute for Parkinson's Disease and Movement Disorders, Christchurch

Sponsors
All Listed Sponsors
collaborator

Chiltern International Inc.

INDUSTRY

lead

Chelsea Therapeutics

INDUSTRY