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“I participate because it is the right thing to do, for myself, for my children, and for the millions of people who have Parkinson’s disease. Without participation there will be no cure.” –Mike, Diagnosed 7 years
Recently Diagnosed with Parkinson's Disease?
If you have recently been diagnosed with Parkinson’s disease (PD) understanding the disease, and learning about the resources available to you, are good first steps.
UPDATED*: A Study to Assess the Clinical Effect of Droxidopa in the Treatment of Symptomatic Neurogenic Orthostatic Hypotension in Participants with Parkinson's Disease
Official Study Title: A multi-center, double-blind, Double-blindClinical study design in which neither investigators nor participants know who is receiving the investigational drug and who is receiving a placebo. randomized, Parallel-Group, Placebo-Controlled study to assess the clinical ClinicalDealing with or based on observation and treatment of people, as opposed to basic science carried out in the laboratory or in animals. effect of droxidopa in the treatment of Symptomatic Neurogenic Orthostatic Hypotension in Patients with Parkinson's disease
Sponsor: Chelsea Therapeutics
Clinicaltrials.gov ID: NCT01176240
Study ID: NOH306
Summary
This is a study to evaluate the effects of an investigational drug, Investigational DrugDrug that is being tested in clinical trials prior to receiving FDA approval for use on the open market or as a treatment for a particular condition. Droxidopa, in participants with neurogenic orthostatic hypotension, a condition associated with Parkinson's disease Parkinson's DiseaseA chronic, slowly progressive disease of the nervous system characterized by the combination of tremor, rigidity, bradykinesia and stooped posture, among other symptoms. (PD) that causes a person’s blood pressure to fall when they stand up. The study duration is approximately 14 weeks including up to two weeks for screening, ScreeningPeriod of selection of clinical trial participants based on ELIGIBILITY CRITERIA. up to two weeks for proper dose finding, followed by an eight week treatment period and a follow-up visit after two weeks. An extension study is also available to continue treatment if determined appropriate by the study doctor.
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 EffectivenessAbility of a drug or treatment to produce a result. 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 and neck discomfort (the coat hanger syndrome);
- Difficulty standing for a short time or a long time; and
- Trouble walking for a short time or a long time.
* Updated studies have new contact information and/or revised study information.
Study Phase
Phase 3
What is a study phase?
Symptoms Addressed: Movement and Non-movement
General PD symptoms, Balance, Postural difficulties
Time Commitment
- Less than six months
- Between eight and 13 study visits over 14 weeks. The visits will include a Screening Visit followed by a Baseline BaselinBeginning measurements against which a participant’s progress can be quantified at the end of a study. visit within two weeks, then between one and six visits within two weeks to find the appropriate dose of study medication. After the appropriate dose is identified then there will be visits scheduled after one, two, four, and eight weeks (a follow-up visit may occur after 10 weeks if appropriate). An extension study is also available to continue treatment if it is determined appropriate by the study doctor.
Eligibility
- Minimum Age: 18
- Gender(s) Accepted: Either
Inclusion Criteria
- Clinical diagnosis of Parkinson’s disease
- Clinical diagnosis of symptomatic neurogenic orthostatic hypotension
- Provide written informed consent Informed ConsentThe process of providing information to potential study participants to help them decide whether or not to enroll in a specific clinical trial. to participate in the study and understand that they may withdraw their consent at any time without prejudice to their future medical care
Exclusion Criteria
- Use of vasoconstricting (blood vessel narrowing) agents for the purpose of increasing blood pressure;
- Participants taking vasoconstricting agents such as ephedrine, dihydroergotamine, or midodrine must stop taking these drugs for at least two days prior to their baseline visit (Visit 2) and throughout the duration of the study - Use of medication for the treatment of essential hypertension (high blood pressure with no identifiable cause)
- Have changed dose, frequency or type of prescribed medication, within two weeks of baseline visit (Visit 2) with the following exceptions:
- Vasoconstricting agents such a ephedrine, dihydroergotamine, or midodrine
- Short courses (less than two weeks) of medications or treatments that do not interfere with, or exacerbate the participant’s condition under study (e.g. antibiotics) - Alcohol or substance abuse within the past 12 months
- Women who are pregnant or breastfeeding
- Women of child bearing potential who are not using at least one method of contraception with her partner
- Male participants who are sexually active with a woman of child bearing potential and not using at least one method of contraception
- Untreated closed angle glaucoma
- Sustained severe high blood pressure
- Any significant uncontrolled cardiac arrhythmia (abnormal electrical activity in the heart)
- History of heart attack (myocardial infarction) within the past two years
- Current unstable angina (chest pain caused by decreased blood flow to the heart muscle)
- Congestive heart failure
- A type of diabetic neuropathy
- History of some types of cancer within the past two years other than certain types of a successfully treated, non-invasive skin and non-invasive cervical cancer.
- Gastrointestinal condition
- Any major surgical procedure within 30 days of the baseline visit (Visit 2)
- Previously treated with droxidopa
- Currently receiving any investigational drug or have received an investigational drug within 30 days of the baseline visit (Visit 2)
Enrollment
Expected Enrollment: 211 (US)
Date Enrollment Began: Jun 2010
Date Enrollment Ends: May 2012
Last Updated Date: Jan 30 2012
Trial Post Date: Jan 15 2012
Website: http://www.chelseatherapeutics.com/pipeline/droxidopa/indications.html
Primary Contacts and Locations
North Carolina
- Christopher Cioffi — Associate Director Clinical Operations
Chelsea Therapeutics
christopher.cioffi@chelseatherapeutics.com
Phone: (704) 973-4216
3530 Toringdon Way, Suite #200
Charlotte, NC 28277
USA
Texas
- Jacque Moffett — Sr. Clinical Team Manager
PPD
jacqueline.moffett@ppdi.com
Phone: (512) 747-5401
7551 Metro Center Drive, Suite #300
Austin, TX 78744
USA
Local Contacts and Locations
Alabama
- Nasrollah Eslami, M.D., Principal Investigator Principal InvestigatorPerson responsible for management of a clinical trial, ensuring it is conducted in compliance with the study protocol. — Mahmonir Mostaghimi, Research Coordinator
Neurology NeurologyThe scientific study of the nervous system, especially in respect to its structure, functions, and abnormalities. Neurodiagnostic Lab
nnlab@charter.net
Phone: (205) 664-2967
1004 First Street North
Suite 330
Alabaster, AL 35007
USA
Arizona
- William D. Grainger, M.D., Principal Investigator — Natalie Wiley, Research Coordinator
Neurological Physicians of Arizona
nwiley@crastudies.com
Phone: (480) 610-0177
726 North Greenfield Road
Suite 110
Gilbert, AZ 85234
USA - Abraham N. Lieberman, M.D., Principal Investigator — Diane Gates, Research Coordinator
Barrow Neurology Clinic
diane.gates@chw.edu
Phone: (602) 406-6298
240 West Thomas Road
Movement Disorders Clinic, Suite 301
Phoenix, AZ 85013
USA - Stephen Flitman, Principal Investigator — Lucia Rodriguez, Research Coordinator
Xenoscience
lrodriguez@xenoscience.com
Phone: (602) 274-9500
2601 N Third Street
Suite 125
Phoenix, AZ 85004
USA - Robert S. Foote, M.D., Principal Investigator — Margie Pazzi, Research Coordinator
Center for Neurosciences
mpazzi@neurotucson.com
Phone: (603) 650-4441
2450 East River Road
Tucson, AZ 85718
USA - Holly A. Shill, M.D., Principal Investigator — Sanja Obradov, Research Coordinator
Banner Health
sanja.obradov@bannerhealth.com
Phone: (623) 832-6504
10515 West Santa Fe Drive
Sun City, AZ 85351
USA
California
- Janet M. Chance, M.D., Principal Investigator — Laura Whitaker, Research Coordinator
Hoag Memorial Hospital, Presbyterian
Laura.Whitaker@hoaghospital.org
Phone: (949) 645-0703
307 Placentia Avenue
Suite 204
Newport Beach, CA 92663
USA - Robert M. Hutchman, M.D., Principal Investigator — Wayne Pickerell, Research Coordinator
Neurosearch, Inc.
wayne.pickerell@neurosearch-usa.com
Phone: (818) 332-7986
19231 Victory Blvd.
Suite 355
Reseda, CA 91335
USA - Arthur H. Levine, M.D., Principal Investigator — Sara Love, Research Coordinator
Caring Clinical Research Clinical ResearchPatient-oriented research conducted with human participants (or on material of human origin such as tissues and specimens) for which an investigator directly interacts with human participants. This area of research includes: mechanisms of human disease, therapeutic interventions, clinical trials, or development of new technologies. Incorporated
slove@caringcrc.com
Phone: (949) 305-7008
23961 Calle de la Magdalena
Suite 305
Laguna Hills, CA 92653
USA - Robert J. Shorr, M.D., Principal Investigator — Wayne Pickerell, Research Coordinator
Neurosearch II, Inc.
wayne.pickerell@neurosearch-usa.com
Phone: (805) 715-1041
2781 Loma Vista Road
Suite C and D
Ventura, CA 93003
USA - Kumarasamy Sivakumar, M.D., Principal Investigator — Eric James Shaver, Research Coordinator
Research Center for Clinical Studies West
eshaver@rccsmail.com
Phone: (661) 726-1515
1314 West Avenue J
Lancaster, CA 93534
USA - Jerome P. Lisk, M.D., Principal Investigator — Alex Lopez, Research Coordinator
Neuro Therapeutics Incorporated
alexander.lopez@neurosearch-usa.com
Phone: ( 626) 250-2070 Ext. 725
630 South Raymond Avenue
Suite 110
Pasadena, CA 91105
USA
Connecticut
- Mohamed N. Hassan, M.D., Principal Investigator — Ellen Volponi, Research Coordinator
Hartford Hospital
evolponi@harthosp.org
Phone: (860) 545-3416
85 Seymour Street
Clinical Research Center, Suite 905
Hartford, CT 06106
USA - Thomas B. Toothaker, Principal Investigator — Angelo Termine, Research Coordinator
Associated Neurologist NeurologistA physician skilled in the diagnosis and treatment of diseases of the nervous system. of Southern Connecticut, PC
atermine@anscneuro.com
Phone: (203) 333-1151, Ext. 2
75 Kings Highway Cutoff
5th Floor
Fairfield, CT 06824
USA
Florida
- Ramon Gil, M.D., Principal Investigator — Jessica Kashmark, Research Coordinator
Parkinson's Disease Treatment Center of Southwest Florida
jkashmark@daystar.net
Phone: (941) 743-4987
4235 Kings Highway
Suite 102
Port Charlotte, FL 33980
USA - David J. McDonald, M.D., Principal Investigator — Sandra Geyer, Research Coordinator
Neurology Associates of Ormond Beach
neurosgeyer@yahoo.com
Phone: (386) 673-2500 x248
8 Mirror Lake Drive
Suite A and B
Ormond Beach, FL 32174
USA - Liliana Montoya, M.D., Principal Investigator — Vicky Thursby, Research Coordinator
Neurostudies Inc.
neurostudies3@daystar.net
Phone: (941) 743-1027
4161 Tamiami Trail
Suite 201
Port Charlotte, FL 33952
USA - Roger Rousseau, M.D., Principal Investigator — Maria Elena Paredes, Research Coordinator
Pharmax Research Clinic, LLC
meparedes@pharmaxrc.com
Phone: (305) 262-4321, Ext. 202
7200 Northwest 7th Street
Suite 350
Miami, FL 33126
USA - Paul K. Winner, D.O., Principal Investigator — Maribel Williams, Research Coordinator
Premiere Research Institute
eneuro@aol.com
Phone: (561) 845-0500
4631 North Congress Avenue
Suite 200
West Palm Beach, FL 33407
USA - Enrique A. Wulff, M.D., Principal Investigator — Cheryl Costa, Research Coordinator
Lovelace Scientific Research
ccosta@lrri.org
Phone: (941) 485-8314
411 Commercial Court
Suite C
Venice, FL 34292
USA - Stuart H. Isaacson, M.D., Principal Investigator — Robert Delaney, Research Coordinator
Parkinson's Disease & Movement Disorder Disoder
rdelaney@parkinsonscenter.org
Phone: (561) 392-1818
951 NW 13th Street
Building 5-E
Boca Raton, FL 33486
USA - Stuart J. Shafer, M.D., Principal Investigator — Victoria Bussey, Research Coordinator
Vero Neurology
vbussey@geodysseyrsch.com
Phone: (772) 569-7039, Ext. 125
1155 35th Lane
Suite 100
Vero Beach, FL 32960
USA - Robert A. Hauser, M.D., Principal Investigator — Holly Delgado, Research Coordinator
University of South Florida Parkinson's Disease and Movement Disorders Center
hdelgado@health.usf.edu
Phone: (813) 396-0751
4001 East Fletcher Avenue, 6th Floor
Tampa, FL 33613
USA
Illinois
- Concetta M. Forchetti, M.D., Principal Investigator — Donnell Stelton, Research Coordinator
Alexian Brothers Hospital Network
donnell.stelton@abbhh.net
Phone: (847) 981-5771
800 Biesterfield Road
Neurosciences Institute, Brock Building
El Grove Village, IL 60007
USA
Louisiana
- Patricio S. Espinosa Prado, M.D., Principal Investigator — Yaira Garzon, Research Coordinator
North Oaks Neurology
yaira.garzon@gmail.com
Phone: (985) 230-7525
15813 Paul Vega, MD Drive
Suite 400
Hammond, LA 70403
USA
Massachusetts
- Bonnie P. Hersh, M.D., Principal Investigator — Linda Miller, Research Coordinator
Harvard Vanguard Medical Associates
linda_miller@vmed.org
Phone: (617) 421-8963
133 Brookline Avenue
Boston, MA 02215
USA
Michigan
- Bradley K. Evans, M.D., Principal Investigator — Cynthia Conquest, Research Coordinator
Northern Michigan Neurology
cconquest@mhc.net
Phone: (231) 935-0340
110 South Madison Street
Traverse City, MI 49684
USA
Mississippi
- William J. Evans, M.D., Principal Investigator — Kimberly Goodyear, Research Coordinator
Gulf Coast Neurology Center, PLLC
kgoodyear.neuro@gmail.com
Phone: (228) 818-9620
3631 Bienville Boulevard
Suite A
Ocean Springs, MS 39564
USA
North Carolina
- James M. Patton, M.D., Principal Investigator — Susan Woodard, Research Coordinator
Asheville Neurology Specialists, PA
research@ashneuro.com
Phone: (828) 210-9300
1200 Ridgefield Boulevard
Suite 250
Asheville, NC 28806
USA - John A. Porter, M.D., Principal Investigator — Tracy Kollman, Research Coordinator
Clinical Trials of America Inc
tkollman@ctamerica.net
Phone: (336) 768-3456
215 Executive Park Boulevard
Winston-Salem, NC 27103
USA
New Jersey
- John V. Bernard, M.D., Principal Investigator — Ruth Eldred, Research Coordinator
Wellness and Research Center
bernardmd@embarqmail.com
Phone: (908) 475-4600
526 Water Street
Belvidere, NJ 07823
USA - Gerald J. Ferencz, M.D., Principal Investigator — Donna Sandler, Research Coordinator
Shore Neurology
shoreresearch2@aol.com
Phone: (732) 575-1695
633 Route 37 West
Toms River, NJ 08755
USA - Arnold S. Witte, M.D., Principal Investigator — Julie Prettyman, Research Coordinator
AdvanceMed Research
jprettyman@advancemed.info
Phone: (609) 895-0735 ext. 134
2 Princess Road
Lawrenceville, NJ 08648
USA
Nevada
- Eric S. Farbman, M.D., Principal Investigator — Margie Hyderkhan, Research Coordinator
University of Nevada School of Medicine
mshyderkhan@medicine.nevada.net
Phone: (702) 671-5070
1707 West Charleston Boulevard
Department of Neurology #220
Las Vegas, NV 89102
USA
New York
- Christopher S. Calder, M.D., Principal Investigator — Suzanne Alterman, Research Coordinator
Upstate Clinical Research, LLC
salterman@upstateneurology.com
Phone: (518) 533-1500
3 Atrium Drive
Suite 205
Albany, NY 12205
USA - Cornelius J. Foley, M.D., Principal Investigator — Lorraine Breuer, Research Coordinator
Parker Jewish Institute For Health Care and Rehabilitation Foundation
lbreuer@parkerinstitute.org
Phone: (718) 289-2102
271-11 76th Avenue
New Hyde Park, NY 11040
USA - Smita D. Kittur, M.D., Principal Investigator — Charity Cowley, Research Coordinator
Neurological Care of CNY
ccowley@neurocarecny.com
Phone: (315) 701-4554
1000 East Genesee Street
Suite 405
Syracuse, NY 13210
USA - Kreitzman, David L., M.D., Principal Investigator — Nancy Gardella, Research Coordinator
researchli@parkinsonscenter.org
Phone: (631) 462-7774
283 Commack Road
Suite 101
Commack, NY 11725
USA - Fabio O. Danisi, M.D., Principal Investigator — Cindy Miller, Research Coordinator
Kingston Neurological Associates
cindy.miller0720@yahoo.com
Phone: (845) 331-5165 ext. 1143
365 Broadway
Kingston, NY 12401
USA - William L. Severt, M.D., Principal Investigator — Sara Lewis, Research Coordinator
Beth Israel Medical Center
salewis@chpnet.org
Phone: (212) 844-6571
100 Union Square East
Department of Movement Disorders, Suite 8K
New York, NY 10003
USA - Alessandro Di Rocco, Principal Investigator — Jamika Singleton-Garvin, Research Coordinator
New York University
mailto:jamika.singleton-garvin@nyumc.org
Phone: (212) 263-5729
145 East 32nd Street
Parkinson and Movement Disorder Center, 2nd Floor
New York, NY 10016
USA
Ohio
- Punit Agrawal, D.O., Principal Investigator — Paige Pancake, Research Coordinator
Ohio State University Medical Center
paige.pancake@osumc.edu
Phone: (614) 292-8607
1581 Dodd Drive
McCampbell Hall, Room 371
Columbus, OH 43210
USA - James P. Maynard, M.D., Principal Investigator — Casey Mussio, Research Coordinator
Community Research
cmussio@communityresearch.com
Phone: (513) 721-3868 ext. 155
4460 Red Bank Expressway
Suite 200
Cincinnati, OH 45227
USA - Lawrence W. Elmer, M.D., Principal Investigator — Julia Spears, Research Coordinator
University of Toledo
julia.spears@utoledo.edu
Phone: (419) 383-6728
3000 Arlington Avenue
MS 1195
Toledo, OH 43614
USA
Oklahoma
- Kevin J. Klos, M.D., Principal Investigator — Shannon Martin, Research Coordinator
Movement Disorder Clinic of Oklahoma PLLC
shannon.martin@mdcok.com
Phone: (918) 392-4530
7302 South Yale Avenue E
Tulsa, OK 74136
USA
Pennsylvania
- Larry A. Dobkin, M.D., Principal Investigator — Johnie Champ, Research Coordinator
Clinical Trials Research Services LLC
jchamp@ctrsllc.com
Phone: (412) 313-1900
201 South Highland Avenue
Suite 102
Pittsburgh, PA 15206
USA - Steven B. Gelfand, M.D., Principal Investigator — Shah Rahimian, Research Coordinator
Ilumina Clinical Associates Ilumina Clinical Associates
srahimian@iluminaclinicals.com
Phone: (724) 349-2325
650 South 13th Street
Johnstown, PA 15904
USA
Texas
- Steven Vernino, M.D., Principal Investigator — Steve Hopkins, Research Coordinator
UT Southwestern Medical Center at Dallas
steve.hopkins@utsouthwestern.edu
Phone: (214) 648-9275
5323 Harry Hines Boulevard
Dallas, TX 75390
USA
Utah
- Mark A. Johnston, M.D., Principal Investigator — Dustin Jackson, Research Coordinator
JM Neuroscience Research
dustinj@jmneuroscience.com
Phone: (801) 583-1781
419 Wakara Way
Suite 200
Salt Lake City, UT 84108
USA
Virginia
- Alan E. Schulman, M.D., Principal Investigator — Melanie Johnson, Reseacrh Coordinator
Neurological Associates, Inc.
mjohnson@nairichmond.com
Phone: (804) 288-2742
7301 Forest Avenue
Suite 300
Richmond, VA 23226
USA - Karen M. Thomas, D.O., Principal Investigator — Kimberly Downey, Research Coordinator
Sentara Neurology Specialists
kmsharbe@sentara.com
Phone: (757) 507-0600
1950 Glenn Mitchell Drive
Suite 200
Virginia Beach, VA 23456
USA
