A Study to Evaluate Fixed Dose Carbidopa/Levodopa/Entacapone Versus Immediate Release Carbidopa/Levodopa
NCT ID: NCT00134966
Last Updated: 2017-05-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
493 participants
INTERVENTIONAL
2005-08-31
2007-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
capsules containing: carbidopa (25 mg), levodopa (100 mg), entacapone (200 mg)
2
capsules containing: carbidopa (25 mg), levodopa (100 mg), entacapone (200 mg)
Interventions
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capsules containing: carbidopa (25 mg), levodopa (100 mg), entacapone (200 mg)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Idiopathic Parkinson's disease with at least 2 cardinal signs of disease: resting tremor, bradykinesia or rigidity
* Parkinson's disease impairment warranting treatment with a levodopa formulation according to the investigator's assessment
Exclusion Criteria
* History of stereotaxic brain surgery for PD (e.g., pallidotomy, deep brain stimulation, tissue transplant)
* Diagnosis of Parkinson's disease for more than 5 years prior to Screening
* Previous use of levodopa in any formulation, entacapone or tolcapone for more than 30 days or anytime within 4 weeks (28 days) prior to baseline
* Use of a dopamine agonist within 4 weeks (28 days) prior to baseline
30 Years
80 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
Responsible Party
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Locations
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Barrow Neurology Clinics at St. Joseph's Hosptial & Medical Center
Phoenix, Arizona, United States
Coastal Neurological Medical Group, Inc
La Jolla, California, United States
Neurosearch, Inc.
Reseda, California, United States
University of Florida Health Science Center
Jacksonville, Florida, United States
Mayo Clinic
Jacksonville, Florida, United States
USF Medical Clinic
Tampa, Florida, United States
Springfield Neurology Associates, LLC
Springfield, Massachusetts, United States
Clinical Neuroscience Center
Southfield, Michigan, United States
Melbourne Internal Medicine Associates
Westlake, Ohio, United States
Westmoreland Neurology Associates, Inc.
Greensburg, Pennsylvania, United States
Lankenau Hospital
Wynnewood, Pennsylvania, United States
NeuroHealth
Warwick, Rhode Island, United States
Coastal Neurology, PA
Beaufort, South Carolina, United States
Senior Adults Specialty Research
Austin, Texas, United States
Baylor College of Medicine, Parkinson's Disease Center
Houston, Texas, United States
Neurology Associates
San Marcos, Texas, United States
Blue Ridge Research Center at Roanoke Neurological Center
Roanoke, Virginia, United States
Heritage Medical Research Clinic
Calgary, Alberta, Canada
Moncton, New Brunswick, Canada
Eastern Health Care - Health Sciences Centre, Neurology Department
HSC Room 5317, 300 Prince Philip Drive, Saint John's, Newfoundland and Labrador, Canada
Neurology Division, Health Science Center
Halifax, Nova Scotia, Canada
Cape Breton Regional Hospital, Neurology Department
Sydney, Nova Scotia, Canada
Grand River Hospital
Kitchener, Ontario, Canada
London Health Sciences Center, University Hospital, Rm. A10-026
London, Ontario, Canada
Centre for Movement Disorders
Markham, Ontario, Canada
Parkinson's & Neurodegenerative Disorders Clinic
Ottawa, Ontario, Canada
Ottawa Hospital, Civic Campus
Ottawa, Ontario, Canada
Hiren Desai Medicine Professional Corporation
Windsor, Ontario, Canada
Neuro Rive Sud
Greenfield Park, Quebec, Canada
Montreal General Hospital
Montreal, Quebec, Canada
Unite des Troubles du Mouvement Andre-Barbeau, CHUM-Hotel-Dieu
Montreal, Quebec, Canada
Centre de Recjerche Clinique du CHUS
Sherbrooke, Quebec, Canada
Dr. Felix Veloso Research
Regina, Saskatchewan, Canada
Quebec Memory and Motor Skills Disorders Clinic
Québec, , Canada
University of Saskatchewan, Royal University Hospital
Saskatoon, , Canada
Neurologická klinika, Univerzita Palackého
I.P.Pavlova 6, Olomouc, Czechia
FN-neurologická klinika
Alej Svobody 80, Plzeň, Czechia
Neurologicka klinika
Katerinska 12, Praha 2, , Czechia
FN-Nemocnice Pardubice
Kyjevska 44, Pardubice, , Czechia
Rambam Medical Center
Haliya Hashniya 8, Haifa District, Israel
Dep. Of Neurology (Bitan 38, EEG institute)
Dep. of Neurology, Zerifin, , Israel
Belinson Campus, Jabotinsky st. Movement Disorder Unit
Petah Tikva, , Israel
Sourasky Medical Center
Weitzman Saint Movement Disorder Clinic, Tel Aviv, , Israel
Clinica Neurologica I - Azienda Ospedaliera-Universitaria Policlinico - Università di Catania
Via Santa Sofia 78, Catania, Italy
"Dipartimento di Neuroscienze Oftalmologia e Genetica (DINOG)
Università Degli Studi Di Genova, Via de Toni 5, Genova, Italy
Unità Operativa Complessa Neurologia - Policlinico Universitario "G. Martino"
Via Consolare Valeria, Messina, Italy
Istituto Nazionale Neurologico "Carlo Besta"
Via Celoria 11, Milano, Italy
Dipartimento di Neuroscienze-Sezione Neurologia Università degli Studi di Pisa- AO S. Chiara
Via Roma, 67, Pisa, Italy
Dipartimento di Scienze Neurologiche Università degli Studi di Roma "La Sapienza" Roma I
Viale dell'Università 30, Roma, Italy
Dipartimento di Neuroscienze-Università degli Studi di Torino
Via Cherasco 15, Torino, Italy
A.O. Istituti Clinici di Perfezionamento-Unita'Operativa Centro Parkinson
Via Bignami 1, Milan, , Italy
Samodzielny Publiczny Szpital Kliniczny Oddzial Kliniczny Neurologii i Epiletologii
Ul. Czerniakowska 231, Warszawa, , Poland
Centrum Neurologii Klinicznej
Ul. Dwernickiego 8, Krakow, , Poland
Klinika Neruologii Wieku Podeszlego
ul.Medykow 14, Katowice, , Poland
Hospitais da Universidade de Coimbra (Serv. Neurologia)
Avenida Bissaya Barreto, Coimbra, , Portugal
Hospital de Santa Maria (Serv. Neurologia)
Avenida Professor Egas Moniz, Lisbon, , Portugal
Hospital de Santo António (Serv. Neurologia)
Largo Professor Abel Salazar, Porto, , Portugal
Istanbul CAPA Medical School
Istanbul University CAPA Medical School, Dept. of Neurology, Istanbul, Turkey (Türkiye)
Hacettepe Medical School, Department of Neurology
Hacettepe Universitesi Hastaneleri Norooji AD Sihhiye, Ankara, , Turkey (Türkiye)
Dokuz Eylul Medical School, Department of Neurology
Noroloji Anabilim Dali Inciralti Izmir, Izmir, , Turkey (Türkiye)
Countries
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References
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Hauser RA, Panisset M, Abbruzzese G, Mancione L, Dronamraju N, Kakarieka A; FIRST-STEP Study Group. Double-blind trial of levodopa/carbidopa/entacapone versus levodopa/carbidopa in early Parkinson's disease. Mov Disord. 2009 Mar 15;24(4):541-50. doi: 10.1002/mds.22343.
Other Identifiers
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CELC200A2305
Identifier Type: -
Identifier Source: org_study_id
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