Clinical trialNCT01176240CompletedPhase 3Interventional

A Two Part Study (306A/306B) to Assess Droxidopa in Treatment of NOH in Patients With Parkinson's Disease

SponsorChelsea TherapeuticsEnrollment225Orthostatic HypotensionParkinson's Disease

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This is a study to evaluate the effects of an investigational drug, Droxidopa, in participants with neurogenic orthostatic hypotension (NOH), associated with Parkinson's disease. Droxidopa is being studied to determine the effects on blood pressure changes upon standing up (orthostatic challenge). Symptoms and activity measurements, including patient reported falls, will be evaluated to determine the effectiveness of the study drug. Symptoms of NOH may include any of the following: * Dizziness, light-headedness, feeling faint or feeling like you may blackout * Problems with vision (blurring, seeing spots, tunnel vision, etc.) * Weakness * Fatigue * Trouble concentrating * Head \& neck discomfort (the coat hanger syndrome) * Difficulty standing for a short time or a long time * Trouble walking for a short time or a long time The study duration is a maximum of approximately 14 weeks including up to 2 weeks for screening, up to 2 weeks for proper dose finding, followed by an 8 week treatment period and a follow-up visit after 2 weeks. A sufficient number of patients will be screened to allow approximately 211 randomized patients. An extension study is also available to continue treatment if determined appropriate by the study doctor. This Study is NCT01132326 sponsored by Chelsea Therapeutics and is enrolling by invitation only.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Lawrence A. Hewitt, Ph.D.
Chelsea Therapeutics, Inc.
Study Chair
clinicaltrials.gov ↗
Robert Hauser, M.D.
University of South Florida
Principal InvestigatorKOL profile →
clinicaltrials.gov ↗
William Schwieterman, M.D.
Chelsea Therapeutics, Inc.
Study Director
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

60 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Neurology Neurodiagnostic Lab
Alabaster, Alabama, United States
Neurological Physicians of Arizona
Gilbert, Arizona, United States
Barrow Neurology Clinic
Phoenix, Arizona, United States
Xenoscience
Phoenix, Arizona, United States
Banner Health
Sun City, Arizona, United States
Center for Neurosciences
Tucson, Arizona, United States
Northwest Neuro Specialists P.L.L.C.
Tucson, Arizona, United States
Caring Clinical Research Incorporated
Laguna Hills, California, United States
Hoag Memorial Hospital, Presbyterian
Newport Beach, California, United States
Neurosearch - Pasadena
Pasadena, California, United States
Alliance Clinical Research, Llc
Poway, California, United States
Neurosearch, Inc.
Reseda, California, United States
Neurosearch Ii, Inc.
Ventura, California, United States
Neurology Consultants Medical Group
Whittier, California, United States
Associated Neurologist of Southern Connecticut, Pc
Fairfield, Connecticut, United States
Hartford Hospital
Hartford, Connecticut, United States
Eastern Connecticut Neurology Specialists
Manchester, Connecticut, United States
Parkinson'S Disease & Movement Disorder Disoder
Boca Raton, Florida, United States
Pharmax Research Clinic, Llc
Miami, Florida, United States
Neurology Associates of Ormond Beach
Ormond Beach, Florida, United States
Neurostudies Inc.
Port Charlotte, Florida, United States
Parkinson'S Disease Treatment Center of Southwest Florida
Port Charlotte, Florida, United States
Lovelace Scientific Research
Sarasota, Florida, United States
Tampa General University of South Florida
Tampa, Florida, United States
Vero Neurology
Vero Beach, Florida, United States
Premiere Research Institute
West Palm Beach, Florida, United States
Emory University
Atlanta, Georgia, United States
Neurology Specialists of Decatur Research Center
Decatur, Georgia, United States
Prism Research Group
Rome, Georgia, United States
Alexian Brothers Hospital Network
Elk Grove Village, Illinois, United States
Precise Clinical Research
Topeka, Kansas, United States
North Oaks Health System
Hammond, Louisiana, United States
Harvard Vanguard Medical Associates
Boston, Massachusetts, United States
Detroit Clinical Research Center
Novi, Michigan, United States
Northern Michigan Neurology
Traverse City, Michigan, United States
Gulf Coast Neurology Center, Pllc
Ocean Springs, Mississippi, United States
University of Nevada School of Medicine
Las Vegas, Nevada, United States
Wellness and Research Center
Belvidere, New Jersey, United States
Advancemed Research
Lawrenceville, New Jersey, United States
Shore Neurology
Toms River, New Jersey, United States

20 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Droxidopa →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 30 Jun 2010
Primary completion: 31 Oct 2012
Completion: 30 Nov 2012
Last update posted: 20 May 2014
Registered enrollment: 225
Registry id: NCT01176240

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.