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Estudios de Eficacia, Seguridad y Tolerabilidad de un Gen Intestinal de Levodopa-Carbidopa en Participantes con Parkinson que Responden a la Levodopa
Titulo Oficial del Estudio: 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
Patrocinador: Solvay Pharmaceuticals, Inc.
Clinicaltrials.gov ID: NCT00660387, NCT00357994
Study ID: S187.3.001, S187.3.002
Resumen
El objetivo primario de estos estudios será demostrar la superioridad del gel intestinal de levodopa-carbidopa sobre el tratamiento vía oral de levodopa/ LevodopaA compound that is converted into dopamine (the brain chemical which is deficient in people with Parkinson's) in the brain. carbidopa durante 12 semanas en personas con la enfermedad de Parkinson avanzada (EP) y fluctuaciones motoras severas. La duración del estudio es de cuatro meses.
El gel intestinal de levodopa-carbidopa es aplicado a la parte superior del intestino a través de un tubo de extensión permanente insertado mediante gastronomía endoscópica percutánea (PEG-J, por sus siglas en inglés, que consiste en una operación quirúrgica para colocar un tubo sin tener que realizar una operación abdominal), para un tratamiento a largo plazo.
La aplicación del gel intestinal de levodopa-carbidopa directamente sobre la parte superior del intestino anticipadamente resultaría en: una aplicación continua de levodopa-carbidopa, evitando el vaciado gástrico por pulsos, y reduciendo las fluctuaciones motoras y la disquinesia.
Fase del Estudio
Fase 3
Cuál es una fase del estudio?
Síntomas tratados: De movimiento y no relacionados al movimiento
Ataques de "congelamiento", Síntomas generales de la EP, Pérdida de habilidades motrices, Dolores musculares, Rigidez, Movimientos incontrolables (disquinesia), Caminar/Andar
Tiempo Comprometido
- Menos de seis meses
- Semanalmente durante las primeras cuatro semanas y luego cada 2 semanas por la duración de las pruebas
Eligibilidad
- Minimum Age: 30
- Gender(s) Accepted: Either
Inclusion Criteria
- EP idiopática
- Respuesta a la levodopa y que los participantes demuestren alguna respuesta durante el tiempo de acción del medicamento según las observaciones de un investigador
- Los participantes demuestran severas fluctuaciones motoras a pesar de los tratamientos optimizados de levodopa para el individuo
Exclusion Criteria
- Diagnóstico poco claro o sospecha de otros síndromes parkinsonianos tales como el Parkinsonismo secundario
- Haber recibido cirugía para el tratamiento de la EP
- Contraindicaciones a la levodopa, o condición que haga el tratamiento poco recomendable
- Personas con cualquier déficit neurológico que pueda interferir con las evaluaciones del estudio
Inscripción
Total Prevista Inscripción: 54 (EE.UU.)
Fecha de Inicio del Estudio: ene 2009
Fecha límite para la inscripción: oct 2011
Última Actualización: mar 05 2009
Trial Post date: feb 12 2009
Website: http://clinicaltrials.gov/ct2/show/NCT00660387
Principal Contacto
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. — Principal Investigator
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 - Mark Lew
University of Southern California
mlew@surgery.usc.edu
Phone: (323) 442-5791
1520 San Pablo Street
Las Angeles, CA 90033
USA - Karen Frei
Parkinson's & Movement Disorder Institute
drkfrei@yahoo.com
Phone: (714) 378-5062
9940 Talbert Ave
Suite 204
Fountain Valley, CA 92708
USA
Colorado
- Brianna Nichols — Study Coordinator
Colorado Neurological Institute
bnickels@thecni.org
Phone: (303) 357-5445
701 East Hampden Avenue
Suite #510
Englewood, CO 80113
USA - Rajeev Kumar — Principal Investigator
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 Bartlet, R.N. — Study Coordinator
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 — Principal Investigator
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 - Collette Hillard — Study Coordinator
Charlotte Neurological Services
chilliard@daystar.net
Phone: (941) 743-4987
2525 Harbor Blvd.
Suite #312
Port Charlotte, FL 33952
USA - Ramon Gil — Principal Investigator
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 — Principal Investigator
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 - Angelica Marconi
Northwestern University
a-marconi@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. — Study Coordinator
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 — Principal Investigator
Rush University Medical Center
Phone: (312) 942-5157
1725 West Harrison Street
Suite #809
Chicago, IL 60612
USA
Kentucky
- John Slevin, M.D. — Principal Investigator
University of Kentucky Medical Center
Phone: (859) 323-6702
Kentucky Clinic
740 S. Limestone Street L445
Lexington, KY 40536
USA - Renee Wagner — Study Coordinator
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. — Study 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. — Principal Investigator
Louisianna State University Health Sciences Center
Phone: (318) 675-8157
Department of Movement Disorders
1501 King's Highway
Shreveport, LA 71130
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 — Principal Investigator
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. — Study Coordinator
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 — Principal Investigator
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. — Study Coordinator
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. — Study Coordinator
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. — Principal Investigator
Raleigh Neurology Associates
Phone: (919) 420-1659
Office of Dr. Hull
1540 Sunday Drive
Raleigh, NC 27607
USA - Mary Allen, R.N. — Study Coordinator
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. — Principal Investigator
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. — Study Coordinator
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 — Study Coordinator
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
cpeterson@nebraskamed.com
Phone: (402) 552-2239
2045 Nebraska Medical Center
Omaha, NE 68198
USA - John Bertoni — Principal Investigator
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. — Study Coordinator
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. — Principal Investigator
North Shore-LIJ Feinstein Institute
Phone: (516) 562-2426
Department of Neurology
350 Community Drive
Manhasset, NY 11030
USA - Joan Bratton — Study Coordinator
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 — Principal Investigator
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
Vermont
- James Boyd — Principal Investigator
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
- Alida Griffith
Principal Investigator
Phone: (429) 899-3115
Evergreen Health Care Center
13030 121st Way NE, Suite 203
Kirkland, WA 98034
USA - Marsha Merrick
Study Coordinator
mgmerrick@evergreenhealthcare.org
Phone: (429) 899-3115
Evergreen Health Care Center
13030 121st Way NE, Suite 203
Kirkland, WA 98034
USA
Wisconsin
- Serena Hung — Principal Investigator
Medical College of Wisconsin
Phone: (414) 805-9719
Department of Neurology
9200 West Wisconsin Avenue
Milwaukee, WI 53226
USA - Clara Schindler — Study Coordinator
Medical College of Wisconsin
cschindler@mcw.edu
Phone: (414) 805-3260
Department of Neurology
9200 West Wisconsin Avenue
Milwaukee, WI 53226
USA
