A Two Part Study (306A/306B) to Assess Droxidopa in Treatment of NOH in Patients With Parkinson's Disease
Public ClinicalTrials.gov record NCT01176240. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multi-center, Double-blind, Randomized, Parallel-Group, Placebo-Controlled Study to Assess the Clinical Effect of Droxidopa in the Treatment of Symptomatic Neurogenic Orthostatic Hypotension in Patients With Parkinson's Disease
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01176240
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 225 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 31, 2010
- Primary completion
- Sep 30, 2012
- Completion
- Oct 31, 2012
- Last update posted
- May 19, 2014
2010 – 2012
United States locations
- U.S. sites
- 60
- U.S. states
- 22
- U.S. cities
- 56
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Neurology Neurodiagnostic Lab | Alabaster | Alabama | 35007 | — |
| Neurological Physicians of Arizona | Gilbert | Arizona | 85234 | — |
| Xenoscience | Phoenix | Arizona | 85004 | — |
| Barrow Neurology Clinic | Phoenix | Arizona | 85013 | — |
| Banner Health | Sun City | Arizona | 85351 | — |
| Center for Neurosciences | Tucson | Arizona | 85718 | — |
| Northwest Neuro Specialists P.L.L.C. | Tucson | Arizona | 85741 | — |
| Caring Clinical Research Incorporated | Laguna Hills | California | 92653 | — |
| Hoag Memorial Hospital, Presbyterian | Newport Beach | California | 92663 | — |
| Neurosearch - Pasadena | Pasadena | California | 91105 | — |
| Alliance Clinical Research, LLC | Poway | California | 92064 | — |
| Neurosearch, Inc. | Reseda | California | 91335 | — |
| Neurosearch II, Inc. | Ventura | California | 93003 | — |
| Neurology Consultants Medical Group | Whittier | California | 90606 | — |
| Associated Neurologist of Southern Connecticut, PC | Fairfield | Connecticut | 06824 | — |
| Hartford Hospital | Hartford | Connecticut | 06106 | — |
| Eastern Connecticut Neurology Specialists | Manchester | Connecticut | 06040 | — |
| Parkinson's Disease & Movement Disorder Disoder | Boca Raton | Florida | 33486 | — |
| Pharmax Research Clinic, LLC | Miami | Florida | 33126 | — |
| Neurology Associates of Ormond Beach | Ormond Beach | Florida | 32174 | — |
| Neurostudies Inc. | Port Charlotte | Florida | 33952 | — |
| Parkinson's Disease Treatment Center of Southwest Florida | Port Charlotte | Florida | 33980 | — |
| Lovelace Scientific Research | Sarasota | Florida | 34233 | — |
| Tampa General University of South Florida | Tampa | Florida | 33606 | — |
| Vero Neurology | Vero Beach | Florida | 32960 | — |
| Premiere Research Institute | West Palm Beach | Florida | 33407 | — |
| Emory University | Atlanta | Georgia | 30329 | — |
| Neurology Specialists of Decatur Research Center | Decatur | Georgia | 30033 | — |
| Prism Research Group | Rome | Georgia | 30165 | — |
| Alexian Brothers Hospital Network | Elk Grove Village | Illinois | 60007 | — |
| Precise Clinical Research | Topeka | Kansas | 66604 | — |
| North Oaks Health System | Hammond | Louisiana | 70403 | — |
| Harvard Vanguard Medical Associates | Boston | Massachusetts | 02215 | — |
| Detroit Clinical Research Center | Novi | Michigan | 48377 | — |
| Northern Michigan Neurology | Traverse City | Michigan | 49684 | — |
| Gulf Coast Neurology Center, PLLC | Ocean Springs | Mississippi | 39564 | — |
| University of Nevada School of Medicine | Las Vegas | Nevada | 89102 | — |
| Wellness and Research Center | Belvidere | New Jersey | 07823 | — |
| AdvanceMed Research | Lawrenceville | New Jersey | 08648 | — |
| Shore Neurology | Toms River | New Jersey | 08755 | — |
| Upstate Clinical Research, LLC | Albany | New York | 12205 | — |
| David L. Kreitzman, M.D., PC | Commack | New York | 11725 | — |
| Kingston Neurological Associates | Kingston | New York | 12401 | — |
| Parker Jewish Institute For Health Care and Rehabilitation Foundation | New Hyde Park | New York | 11040-1433 | — |
| Beth Israel Medical Center | New York | New York | 10003 | — |
| New York University | New York | New York | 10016 | — |
| Neurological Care of CNY | Syracuse | New York | 13210 | — |
| Asheville Neurology Specialists, PA | Asheville | North Carolina | 28806 | — |
| Guilford Neurologic Associates | Greensboro | North Carolina | 27405 | — |
| Clinical Trials of America Inc | Winston-Salem | North Carolina | 27103 | — |
| Community Research | Cincinnati | Ohio | 45227 | — |
| Ohio State University Medical Center | Columbus | Ohio | 43210 | — |
| University of Toledo | Toledo | Ohio | 43614 | — |
| Movement Disorder Clinic of Oklahoma PLLC | Tulsa | Oklahoma | 74136 | — |
| Ilumina Clinical Associates | Johnstown | Pennsylvania | 15904 | — |
| Clinical Trials Research Services LLC | Pittsburgh | Pennsylvania | 15206 | — |
| UT Southwestern Medical Center at Dallas | Dallas | Texas | 75390-9063 | — |
| JM Neuroscience Research | Salt Lake City | Utah | 84108 | — |
| Neurological Associates, Inc. | Richmond | Virginia | 23226 | — |
| Sentara Neurology Specialists | Virginia Beach | Virginia | 23456 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01176240, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 19, 2014 · Synced Sep 5, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01176240 live on ClinicalTrials.gov.