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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: Abbott Products 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 four weeks and then every two 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: 62 (US)
Date Enrollment Began: Jan 2009
Date Enrollment Ends: Sep 2011
Last Updated Date: Sep 15 2011
Trial Post Date: May 12 2011
Website: http://www.advancedpdstudy.com
Primary Contacts and Locations
Illinois
- Elizabeth Hoening — Research Management Associate
Abbott Laboratories
Phone: (847) 937-4979
100 Abbott Park Road
Dept R477, Bldg AP4-1
Abbott Park, IL 60064
USA
Local Contacts and Locations
Alabama
- Jennifer Newsome, Study Coordinator — David Standaert, Principal Investigator
University of Alabama at Birhmingham Department of Neurology
jnewsome@uab.edu
Phone: (205) 996-7499
1720 7th Ave. S.
Birmingham, AL 35222
USA
California
- Estela Soto — Michael Lobatz, Principal Investigator
The Research Center of Southern California
sotoe@neurocenter.com
Phone: (760) 732-0557 Ext. 2123
320 Santa Fe Drive
Suite 108
Encinitas, CA 92024
USA - Rosie Magallon, Study Coordinator — Karen Frei, Principal Investigator
Parkinson's & movement Disorder Institute
rmagallon@pmdi.org
Phone: (714) 378-5021
9940 Talbert Ave.
Suite 204
Fountain Valley, CA 92708
USA - Connie Kawai, Study Coordinator — Mark Lew, Principal Investigator
University of Southern California
ckawai@surgery.usc.edu
Phone: (323) 442-5814
1520 San Pablo Street
Suite 3000
Los Angeles, CA 90033
USA
Colorado
- Brianna Nickels, Study Coordinator — Rajeev Kumar, Principal Investigator
Colorado Neurological Institute
bnickels@thecni.org
Phone: (303) 357-5445
Rocky Mount Movement Disorders Center - PC
701 East Hampden Avenue, Suite 510
Englewood, CO 80113
USA
District Of Columbia
- Denise Bartlett, Study Coordinator — Fernando Pagan, Principal Investigator
Georgetown University Hospital Department of Neurology NeurologyThe scientific study of the nervous system, especially in respect to its structure, functions, and abnormalities. - Movement Disorders
bartletd@georgetown.edu
Phone: (202) 444-2658
3800 Reservoir Road, NW
7PHC
Washington, DC 20007
USA
Florida
- Sally Thimm, Study Coordinator — Ramon, Gil
Charlotte Neurological Services
sethimm@aol.com
Phone: (941) 743-4987
4235 Kings Highway
Suite 102
Port Charlotte, FL 33980
USA - Lisa Smith, Study Coordinator — Zhigao Huang, Principal Investigator
University of Florida Neuroscience Institute
lisa.smith@jax.ufl.edu
Phone: (904) 244-9480
580 W. 8th Street
Tower A, 9th Floor
Jacksonville, FL 32209
USA - Laurie Emmert, Study Coordinator — William McElveen, Principal Investigator
Bradenton Research Center Inc.
laurieemmert@bradentonresearch.com
Phone: (941) 708-0005 Ext. 16
Dr. McElveens' Office
3924 9th Ave. West
Bradenton, FL 34205
USA - Teri Green, Study Coordinator — Ramon Rodriguez, Principal Investigator
University of Florida Department of Neurology
teri.green@neurology.ufl.edu
Phone: (352) 273-9528
219 Grinter Hall, Box 115500
Cardiology Department
Gainesville, FL 32611
USA
Illinois
- Laura Wulf, Study Coordinator — Cindy Zadikoff, Principal Investigator
Northwestern University
la-wulf@northwestern.edu
Phone: (312) 503-1999
Northwestern Medical Faculty Foundation
710 N. Lake Shore Drive, Abbott Hall, 11th Floor
Chicago, IL 60611
USA
Kentucky
- Renee Wagner, Study Coordinator — John Slevin, Principal Investigator
University of Kentucky Medical Center Clinical ClinicalDealing with or based on observation and treatment of people, as opposed to basic science carried out in the laboratory or in animals. Research, Development and Operations Center
renee.wagner@uky.edu
Phone: (859) 323-0028
740 S. Limestone Street
L445
Lexington, KY 40536
USA
Maryland
- Nancy Zappala, Study Coordinator — Bradley Robottom, Principal Investigator
University of Maryland School of Medicine
nzappala@som.umaryland.edu
Phone: (410) 328-7812
110 S. Paca Street
Room 3-S-127
Baltimore, MD 21201
USA
Missouri
- Kathy Wharton, Study Coordinator — Brad Racette
Washington University Movement Disorders Center
whartonk@neuro.wustl.edu
Phone: (314) 362-2059
660 S. Euclid Avenue
Campus Box 8111
St. Louis, MO 63110
USA
North Carolina
- Sara Vaughan, Study Coordinator — Mustafa Siddiqui, Principal Investigator
Wake Forest University School of Medicine
svaughan@wfubmc.edu
Phone: (336) 716-8694
Medical Center Blvd.
Winston Salem, NC 27157
USA
New York
- Joan Bratton, Study Coordinator — Catherine Cho, Principal Investigator
Mount Sinai Medical Center
joan.bratton@mssm.edu
Phone: (212) 241-2477
One Gustave Levy Place
Box 1139
New York, NY 10029
USA - Ani Arkun, Study Coordinator — Cheryl Waters, Principal Investigator
Columbia University Medical Center Neurological Institute
a2089@mail.cumc.columbia.edu
Phone: (212) 305-6121
710 W. 168th St.
NI-3
New York, NY 10032
USA
Ohio
- Kristy Sullivan, Study Coordinator — Alberto Espay, Principal Investigator
University Neurology, Inc.
sullivk5@ucmail.uc.edu
Phone: (513) 558-6517
260 Stetson Street
Suite 2300
Cincinnati, OH 45267
USA
Vermont
- Christopher Ingvoldstad, Study Coordinator — James Boyd, Principal Investigator
Fletcher Allen Health Care/University of Vermont
christopher.ingvoldstad@med.uvm.edu
Phone: (802) 656-3878
89 Beaumont Avenue
Given C 219
Burlington, VT 05405
USA
Washington
- Marsha Merrick, Study Coordinator — Alida Griffith, Principal Investigator
Evergreen Healthcare Center
mgmerrick@evergreenhealthcare.org
Phone: (425) 899-3115
12039 NE 128th St.
3rd Floor
Kirkland, WA 98034
USA
