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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.
Studies of Efficacy, Safety and Tolerability of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Participants - Still Enrolling!
Official Study Title: A Randomized, 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. Double Dummy, Efficacy, EfficacyThe extent to which a specific intervention, procedure, or regimen produces a beneficial result under ideal conditions. Safety and Tolerability Study of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects Receiving Optimized Treatments with Parkinson Medicinal Products who Continue to Experience Persistent Motor Fluctuations
Sponsor: Solvay Pharmaceuticals, Inc.
Clinicaltrials.gov ID: NCT00660387, NCT00357994
Study ID: S187.3.001, S187.3.002
Summary
The primary objective of these studies will be to demonstrate the superiority of levodopa-carbidopa intestinal gel over treatment with oral levodopa/ LevodopaA compound that is converted into dopamine (the brain chemical which is deficient in people with Parkinson's) in the brain. carbidopa CarbidopaDrug given in combination with levodopa to ensure that more of the latter reaches the brain and changes into dopamine, rather than being broken down in the bloodstream. This allows for lower doses of levodopa to be used, reducing the risk of nausea, vomiting, and other side effects. during 12 weeks in people with advanced Parkinson’s disease (PD) and severe motor fluctuations. The study duration is four months.
Levodopa-carbidopa intestinal gel is delivered to the upper intestine through a permanent extension tube inserted via percutaneous endoscopic gastrostomy (PEG-J, or a surgical procedure for placing the tube without having to perform an abdominal operation), for long-term treatment.
The delivery of levodopa-carbidopa intestinal gel directly to the upper intestine is anticipated to result in: continuous delivery of levodopa-carbidopa, avoidance of pulsating gastric emptying, and decreased motor fluctuations and dyskinesia. DyskinesiaTwisting, turning or other abnormal involuntary movement usually involving the arms, legs, trunk, and head. It is most commonly associated with long-term use of levodopa.
Study Phase
Phase 3
What is a study phase?
Symptoms Addressed: Movement and Non-movement
Freeze Attacks, Freeze AttacksThe sudden loss of ability to move. General PD symptoms, Loss of Motor Skills, Muscle Pain, Rigidity, RigidityA symptom in which muscles feel stiff and display resistance to movement even when another person tries to move the affected part of the body. Uncontrollable movements (Dyskinesia), Walking/Gait GaitWay of walking, which is diminished in people with Parkinson’s who tend to shuffle their feet, take too short steps, and not swing one or both arms.
Time Commitment
- Less than six months
- Weekly for the first 4 weeks and then every 2 weeks for the duration of the trials
Eligibility
- Minimum Age: 30
- Gender(s) Accepted: Either
Inclusion Criteria
- Idiopathic IdiopathicOf, relating to, or designating a disease having no known cause. PD
- Levodopa-responsive and participants demonstrate some identifiable "ON response" as observed by investigator
- Participants demonstrate severe motor fluctuations in spite of individually optimized levodopa treatment
Exclusion Criteria
- Diagnosis is unclear or a suspicion of other parkinsonian syndromes Parkinsonian SyndromesA group of diseases characterized by symptoms (e.g. tremor, rigidity or stiffness, slow movements and difficulty maintaining balance) common in Parkinson's disease. exists such as secondary Parkinsonism
- Undergone surgery for the treatment of PD
- Contraindications to levodopa, or a condition which makes the treatment inadvisable
- People with any neurological deficit that may interfere with the study assessments
Enrollment
Expected Enrollment: 54 (US)
Date Enrollment Began: Jan 2009
Date Enrollment Ends: Jul 2010
Last Updated Date: Feb 25 2010
Trial Post Date: Feb 12 2009
Website: http://clinicaltrials.gov/ct2/show/NCT00660387
Primary Contacts and Locations
Georgia
- Staci Rokette — Senior Clinical ClinicalDealing with or based on observation and treatment of people, as opposed to basic science carried out in the laboratory or in animals. Program Manager
Solvay Pharmaceuticals
Staci.Rokette@solvay.com
Phone: (770) 579-7430
1800 Parkway Place
Suite 500
Marietta, GA 30067
USA
Local Contacts and Locations
Alabama
- Jennifer Newsome, Study Coordinator
David Standaert, Principal Investigator
jnewsome@uab.edu
Phone: (205) 996-7499
University of Alabama at Birmingham
1719 6th Ave, Rm 516
Birmingham, AL 35233
USA
California
- Neal Hermanowicz, M.D. — Study Coordinator
University of California Medical Center / Irvine Medical Center
Phone: (949) 824-0190
Department of Neurology
100 Irvine Hall
Irvine, CA 92697
USA - Shari Niswonger
University of California Medical Center / Irvine Medical Center
shari.niswonder@uci.edu
Phone: (949) 824-8116
Department of Neurology
100 Irvine Hall
Irvine, CA 92697
USA - Michael Lobatz
The Research Center of Southern California
Phone: (760) 732-0557
3907 Waring Road
Suite #3
Oceanside, CA 92056
USA
Colorado
- Brianna Nichols
Colorado Neurological Institute
bnickels@thecni.org
Phone: (303) 357-5445
701 East Hampden Avenue
Suite #510
Englewood, CO 80113
USA - Rajeev Kumar — Study Coordinator
Colorado Neurological Institute
rajeev_kumar@msn.com
Phone: (303) 783-4974
701 East Hampden Avenue
Suite #510
Englewood, CO 80113
USA
District Of Columbia
- Denise Bartlett, R.N.
Georgetown University Hospital
bartletd@georgetown.edu
Phone: (202) 444-1382
Department of Neurology NeurologyThe scientific study of the nervous system, especially in respect to its structure, functions, and abnormalities. - Movement Disoders
3800 Reservoir Road, NW, #7PHC
Washington, DC 20007
USA - Fernando Pagan — Study Coordinator
Georgetown University Hospital
Phone: (202) 444-1382
Department of Neurology - Movement Disoders
3800 Reservoir Road, NW, #7PHC
Washington, DC 20007
USA
Florida
- Lisa Smith, Study Coordinator
Zhigao Huang, Principal Investigator
lisa.smith@jax.ufl.edu
Phone: (904) 244-9480
University of Florida, Department of Neurology
580 West 8th Street, 9th Floor, Tower A
Jacksonville, FL 32209
USA - Teri Green, Study Coordinator
Hubert Fernandez, Principal Investigator
teri.green@neurology.ufl.edu
Phone: (352) 273-5550
University of Florida
South Newell Drive, L3-100
Tampa, FL 32610
USA - Kathryn Panicek, Study Coordinator
Robert Hauser, Principal Investigator
kpanicek@health.usf.edu
Phone: (813) 844-4477
University of South Florida Medical Center
4 Columbia Drive, Suite 410
Tampa, FL 33606
USA - Jonathan Harris
Neurologic Consultants, P.A.
brainville@incresearch.com
Phone: (954) 776-9111
1841 NE 45th Street
Ft. Lauderdale, FL 33308
USA - William McElveen
Bradenton Research Center, Inc.
bradenton_neurologyds@hotmail.com
Phone: (941) 708-0005
Dr. McElveens' Office
3924 9th Avenue West
Bradenton, FL 34205
USA - Carol Ann Swink
Charlotte Neurological Services
cswink@daystar.net
Phone: (941) 743-4987
2525 Harbor Blvd.
Suite #312
Port Charlotte, FL 33952
USA - Ramon Gil — Study Coordinator
Charlotte Neurological Services
rgil@daystar.net
Phone: (941) 743-4987
2525 Harbor Blvd.
Suite #312
Port Charlotte, FL 33952
USA
Georgia
- Buff Dill, Study Coordinator
Kapil Sethi, Principal Investigator
bdill@mcg.edu
Phone: (706) 721-2798
Medical College of Georgia
1429 Harper St HF-1121B
Augusta, GA 30912
USA
Illinois
- Cindy Zadikoff
Northwestern Medical Faculty Foundation
czadikoff@nmff.org
Phone: (312) 503-2970
Department of Dermatology Galter Pavilion
675 N. St. Clair Street Suite #19-200
Chicago, IL 60611
USA - Teresa Kuhta
Northwestern University
t_kuhta@northwestern.edu
Phone: (312) 503-1999
Department of Dermatology Galter Pavilion
675 N. St. Clair Street Suite #19-200
Chicago, IL 60611
USA - Jean Jaglin, R.N., C.C.R.C.
Rush University Medical Center
jean_a_jaglin@rush.edu
Phone: (312) 942-5157
1725 West Harrison Street
Suite #809
Chicago, IL 60612
USA - Leonard Verhagen — Study Coordinator
Rush University Medical Center
Phone: (312) 942-5157
1725 West Harrison Street
Suite #809
Chicago, IL 60612
USA
Kentucky
- John Slevin, M.D.
University of Kentucky Medical Center
Phone: (859) 323-6702
Kentucky Clinic
740 S. Limestone Street L445
Lexington, KY 40536
USA - Renee Wagner
University of Kentucky Medical Center
renee.wagner@uky.edu
Phone: (859) 323-0028
Kentucky Clinic
740 S. Limestone Street L445
Lexington, KY 40536
USA
Louisiana
- Labrilla Johnson, R.N. — Clinical Coordinator
Louisiana State University Health Sciences Center
ljoh23@lsuhsc.edu
Phone: (318) 675-8157
Department of Movement Disorders
1501 King's Highway
Shreveport, LA 71130
USA - Richard Zweig, M.D. — Study Coordinator
Louisianna State University Health Sciences Center
Phone: (318) 675-8157
Department of Movement Disorders
1501 King's Highway
Shreveport, LA 71130
USA
Massachusetts
- Peggy Rose, Study Coordinator
Daniel Tarsy, Principal Investigator
prose1@bidmc.harvard.edu
Phone: (617) 667-0519
Beth Israel Deaconess Medical Center
330 Brookline Ave, Shapiro 809d
Boston, MA 02215
USA
Maryland
- Bradley Robottom
University of Maryland School of Medicine
nzappala@som.umaryland.edu
Phone: (410) 328-2164
110 S. Paca Street
3rd Floor
Baltimore, MD 21201
USA - Joseph Savitt — Study Coordinator
Johns Hopkins University
Phone: (410) 614-0577
Department of Neurology - Movement Disorders
600 North Wolfe Street Meyer #6-119
Baltimore, MD 21287
USA - Melissa Gerstenhaber, R.N.C., M.S.N.
Johns Hopkins Hospital
mgerste1@jhmi.edu
Phone: (410) 614-1242
Department of Neurology - Movement Disorders
600 North Wolfe Street Meyer #6-119
Baltimore, MD 21287
USA
Missouri
- Brad Racette — Study Coordinator
Washington University School of Medicine
Phone: (314) 362-8548
Movement Disorders Center
660 S. Euclid Avenue Campus Box #8111
St. Louis, MO 63110
USA - Kathy Wharton, R.N.
Washington University School of Medicine
whartonk@neuro.wustl.edu
Phone: (314) 362-2059
Movement Disorders Center
660 S. Euclid Avenue Campus Box #8111
St. Louis, MO 63110
USA - Mary Creech, R.N., M.S.W., L.C.S.W.
Washington University School of Medicine
maryc@npg.wustl.edu
Phone: (314) 362-7651
Movement Disorders Center
660 S. Euclid Avenue Campus Box #8111
St. Louis, MO 63110
USA
North Carolina
- Sara Thrower, Study Coordinator
Mustafa Siddiqui, Principal Investigator
sathrower@wfubmc.edu
Phone: (336) 716-8694
Wake Forest University School of Medicine
Neurology, Medical Center Blvd.
Winston Salem, NC 27157
USA - Keith Hull, Jr., M.D. — Study Coordinator
Raleigh Neurology Associates
Phone: (919) 420-1659
Office of Dr. Hull
1540 Sunday Drive
Raleigh, NC 27607
USA - Mary Allen, R.N.
Raleigh Neurology Associates, P.A.
mallen@raleighneurology.com
Phone: (919) 782-3456, EXT. #8265
Office of Dr. Hull
1540 Sunday Drive
Raleigh, NC 27607
USA - Sanjay Iyer, M.D. — Study Coordinator
Carolinas Medical Center
Phone: (704)446-1909
Neuroscience and Spine Institute
1010 Edgehill Road North
Charlotte, NC 28207
USA - Joanne Nemeth, R.N., B.S.N.
Carolinas Medical Center
joanne.nemeth@carlinashealthcare.org
Phone: (704) 446-0803
Neuroscience and Spine Institute
1010 Edgehill Road North
Charlotte, NC 28207
USA - Jacqueline Foster
Carolinas Medical Center
jacqueline.foster@carolinas.org
Phone: (704) 446-1909
Neuroscience and Spine Institute
1010 Edgehill Road North
Charlotte, NC 28207
USA
Nebraska
- Carolyn Peterson, Study Coordinator
John Bertoni, Principal Investigator
cpeterson@nebraskamed.com
Phone: (402) 552-2239
Creighton Neurology
601 N 30th St
Omaha, NE 68131
USA - Carolyn Peterson, Study Coordinator
John Bertoni, Principal Investigator
cpeterson@nebraskamed.com
Phone: (402) 552-2239
2045 Nebraska Medical Center
Omaha, NE 68198
USA - John Bertoni
University of Nebraska Medical Center
Phone: (402) 559-8932
2045 Nebraska Medical Center
Omaha, NE 68198
USA
New York
- Ani Arkun, Study Coordinator
Cheryl Waters, Principal Investigator
aarkun@neuro.columbia.edu
Phone: (212) 305-3665
710 W 168th St NI-3
New York, NY 11355
USA - Jean Ayan, R.N.
North Shore Medical Center - Long Island Jewish Feinstein Institute
jayan@nshs.edu
Phone: (516) 562-2426
Department of Neurology
350 Community Drive
Manhasset, NY 11030
USA - Michael Pourfar, M.D. — Primary Investigator
North Shore-LIJ Feinstein Institute
Phone: (516) 562-2426
Department of Neurology
350 Community Drive
Manhasset, NY 11030
USA - Joan Bratton
Mount Sinai Medical Center
joan.bratton@mssm.edu
Phone: (212) 659-5643
Department of Movement Disorders - Dr. Tagliati
5 East 98th Street 1st Floor, Box #1139
New York, NY 10029
USA - Michele Tagliati — Study Coordinator
Mount Sinai Medical Center
Phone: (516) 470-6974
Department of Movement Disorders - Dr. Tagliati
5 East 98th Street 1st Floor, Box #1139
New York, NY 10029
USA
Ohio
- Michele Janszen, Study Coordinator
Alberto Espay, Principal Invesigator
janszema@ucmail.uc.edu
Phone: (513) 558-0125
University Neurology, Inc.
222 Piedmont Ave
Cincinatti, OH 45219
USA - Scott Jenera, Study Coordinator
Ilia Itin, Principal Invesigator
scottj2@ccf.org
Phone: (216) 445-3862
Cleveland Clinic
9500 Euclid
Cleveland, OH 44195
USA - Dawn Denallo
Cleveland Clinic
danalld@ccf.org
Phone: (216) 445-3862
Office of Dr. Illia Itin
9500 Euclid Avenue
Cleveland, OH 44195
USA - Illia Itin, M.D. — Study Coordinator
Cleveland Clinic
itini@ccf.org
Phone: (216) 445-3862
Office of Dr. Illia Itin
9500 Euclid Avenue
Cleveland, OH 44195
USA
Pennsylvania
- Mary Lloyd, Study Coordinator
Howard Hurtig, Principal Investigator
mlloyd@pahosp.com
Phone: (215) 829-7915
Pennsylvania Hospital
330 South 9th St
Philadelphia, PA 19107
USA - Gabriel Tatarian — Study Coordinator
Thomas Jefferson University Hospitals
Phone: (215) 955-8700
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. Research Unit
1015 Chestnut Street Suite #520
Philadelphia, PA 19107
USA - Stephanie Sendek
Thomas Jefferson University Hospitals
stephanie.sendek@jefferson.edu
Phone: (215) 955-8700
Parkinson's Disease Research Unit
1015 Chestnut Street Suite #520
Philadelphia, PA 19107
USA
Vermont
- James Boyd
Fletcher Allen Health Care / University of Vermont
james.boyd@vtmednet.org
Phone: (802) 847-4589
1 South Prospect Street
4th Floor
Burlington, VT 05401
USA - Sharon Kenney — Study Coordinator
Fletcher Allen Health Care / University of Vermont
sharon.kenney@uvm.edu
Phone: (802) 847-4589
1 South Prospect Street
4th Floor
Burlington, VT 05401
USA
Washington
- Marsha Merrick, Study Coordinator
Monique Giroux, Principal Investigator
mgmerrick@evergreenhealthcare.org
Phone: (429) 899-3115
Evergreen Health Care Center
13030 121st Way NE, Suite 203
Kirkland, WA 98034
USA
Wisconsin
- Clara Schindler
Medical College of Wisconsin
cschindler@mcw.edu
Phone: (414) 805-3260
Department of Neurology - Dr. Hung
9200 West Wisconsin Avenue
Milwaukee, WI 53226
USA - Department of Neurology - Dr. Hung
9200 West Wisconsin Avenue
Milwaukee, WI 53226
USA - Serena Hung — Study Coordinator
Medical College of Wisconsin
Phone: (414) 805-9719
Department of Neurology - Dr. Hung
9200 West Wisconsin Avenue
Milwaukee, WI 53226
USA
