A Study to Evaluate Fixed Dose Carbidopa/Levodopa/Entacapone Versus Immediate Release Carbidopa/Levodopa
- Conditions
- Parkinson's Disease
- Registration Number
- NCT00134966
- Lead Sponsor
- Novartis
- Brief Summary
The purpose of this study is to achieve approval for the use of carbidopa/levodopa/entacapone in early Parkinson's disease (PD) by demonstrating that when used as initial levodopa therapy in early PD, carbidopa/levodopa/entacapone provides significantly greater symptomatic benefit than immediate release carbidopa/levodopa administered at the same levodopa dosage level of 100 mg three times a day (t.i.d.).
- Detailed Description
The purpose of this study is to achieve approval for the use of carbidopa/levodopa/entacapone in early Parkinson's disease (PD) by demonstrating that when used as initial levodopa therapy in early PD, carbidopa/levodopa/entacapone provides significantly greater symptomatic benefit than immediate release carbidopa/levodopa administered at the same levodopa dosage level 100 mg t.i.d.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 493
- Aged 30 to 80 years, inclusive, at time of Parkinson's disease diagnosis
- 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
- History, signs or symptoms suggesting the diagnosis of atypical or secondary Parkinsonism due to drugs, metabolic disorders, encephalitis or other neurodegenerative diseases
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Symptom control change from baseline to week 39
- Secondary Outcome Measures
Name Time Method Change from baseline to week 39 in incidence of dyskinesia and wearing off Change from baseline to week 39 in mental acuity Change from baseline to week 39 in activities of daily living Change from baseline to week 39 in motor function
Trial Locations
- Locations (59)
Dr. Felix Veloso Research
๐จ๐ฆRegina, Saskatchewan, Canada
Istituto Nazionale Neurologico "Carlo Besta"
๐ฎ๐นVia Celoria 11, Milano, Italy
Dipartimento di Scienze Neurologiche Universitร degli Studi di Roma "La Sapienza" Roma I
๐ฎ๐นViale dell'Universitร 30, Roma, Italy
Neurologicka klinika
๐จ๐ฟKaterinska 12, Praha 2, Czechia
FN-neurologickรก klinika
๐จ๐ฟAlej Svobody 80, Plzeล, Czechia
FN-Nemocnice Pardubice
๐จ๐ฟKyjevska 44, Pardubice, Czechia
Coastal Neurological Medical Group, Inc
๐บ๐ธLa Jolla, California, United States
Barrow Neurology Clinics at St. Joseph's Hosptial & Medical Center
๐บ๐ธPhoenix, Arizona, United States
Neurosearch, Inc.
๐บ๐ธReseda, California, United States
Mayo Clinic
๐บ๐ธJacksonville, Florida, United States
University of Florida Health Science Center
๐บ๐ธJacksonville, Florida, United States
USF Medical Clinic
๐บ๐ธTampa, Florida, United States
Clinical Neuroscience Center
๐บ๐ธSouthfield, Michigan, United States
Melbourne Internal Medicine Associates
๐บ๐ธWestlake, Ohio, United States
Springfield Neurology Associates, LLC
๐บ๐ธSpringfield, Massachusetts, United States
NeuroHealth
๐บ๐ธWarwick, Rhode Island, United States
Westmoreland Neurology Associates, Inc.
๐บ๐ธGreensburg, Pennsylvania, United States
Lankenau Hospital
๐บ๐ธWynnewood, Pennsylvania, United States
Neurology Associates
๐บ๐ธSan Marcos, Texas, United States
Baylor College of Medicine, Parkinson's Disease Center
๐บ๐ธHouston, Texas, United States
Heritage Medical Research Clinic
๐จ๐ฆCalgary, Alberta, Canada
Eastern Health Care - Health Sciences Centre, Neurology Department
๐จ๐ฆHSC Room 5317, 300 Prince Philip Drive, St. John's, Newfoundland and Labrador, Canada
Neurology Division, Health Science Center
๐จ๐ฆHalifax, Nova Scotia, Canada
Cape Breton Regional Hospital, Neurology Department
๐จ๐ฆSydney, Nova Scotia, Canada
Grand River Hospital
๐จ๐ฆKitchener, Ontario, Canada
London Health Sciences Center, University Hospital, Rm. A10-026
๐จ๐ฆLondon, Ontario, Canada
Centre for Movement Disorders
๐จ๐ฆMarkham, Ontario, Canada
Ottawa Hospital, Civic Campus
๐จ๐ฆOttawa, Ontario, Canada
Parkinson's & Neurodegenerative Disorders Clinic
๐จ๐ฆOttawa, Ontario, Canada
Neuro Rive Sud
๐จ๐ฆGreenfield Park, Quebec, Canada
Montreal General Hospital
๐จ๐ฆMontreal, Quebec, Canada
Unite des Troubles du Mouvement Andre-Barbeau, CHUM-Hotel-Dieu
๐จ๐ฆMontreal, Quebec, Canada
Centre de Recjerche Clinique du CHUS
๐จ๐ฆSherbrooke, Quebec, Canada
Neurologickรก klinika, Univerzita Palackรฉho
๐จ๐ฟI.P.Pavlova 6, Olomouc, Czechia
Quebec Memory and Motor Skills Disorders Clinic
๐จ๐ฆQuebec, Canada
University of Saskatchewan, Royal University Hospital
๐จ๐ฆSaskatoon, Canada
Rambam Medical Center
๐ฎ๐ฑHaliya Hashniya 8, Haifa, Israel
Dep. Of Neurology (Bitan 38, EEG institute)
๐ฎ๐ฑDep. Of Neurology, Zerifin, Israel
Belinson Campus, Jabotinsky st. Movement Disorder Unit
๐ฎ๐ฑPetach Tikva, Israel
Sourasky Medical Center
๐ฎ๐ฑWeitzman St. Movement Disorder Clinic, Tel Aviv, Israel
Clinica Neurologica I - Azienda Ospedaliera-Universitaria Policlinico - Universitร di Catania
๐ฎ๐นVia Santa Sofia 78, Catania, Italy
Unitร Operativa Complessa Neurologia - Policlinico Universitario "G. Martino"
๐ฎ๐นVia Consolare Valeria, Messina, Italy
"Dipartimento di Neuroscienze Oftalmologia e Genetica (DINOG)
๐ฎ๐นUniversitร degli Studi di Genova, Via De Toni 5, Genova, Italy
Dipartimento di Neuroscienze-Sezione Neurologia Universitร degli Studi di Pisa- AO S. Chiara
๐ฎ๐นVia Roma, 67, Pisa, Italy
Dipartimento di Neuroscienze-Universitร degli Studi di Torino
๐ฎ๐นVia Cherasco 15, Torino, Italy
A.O. Istituti Clinici di Perfezionamento-Unita'Operativa Centro Parkinson
๐ฎ๐นVia Bignami 1, Milan, Italy
Samodzielny Publiczny Szpital Kliniczny Oddzial Kliniczny Neurologii i Epiletologii
๐ต๐ฑul. Czerniakowska 231, Warszawa, Poland
Centrum Neurologii Klinicznej
๐ต๐ฑUl. Dwernickiego 8, Krakow, Poland
Hospitais da Universidade de Coimbra (Serv. Neurologia)
๐ต๐นAvenida Bissaya Barreto, Coimbra, Portugal
Klinika Neruologii Wieku Podeszlego
๐ต๐ฑul.Medykow 14, Katowice, Poland
Hospital de Santa Maria (Serv. Neurologia)
๐ต๐นAvenida Professor Egas Moniz, Lisbon, Portugal
Istanbul CAPA Medical School
๐น๐ทIstanbul University CAPA Medical School, Dept. of Neurology, Istanbul, Turkey
Hacettepe Medical School, Department of Neurology
๐น๐ทHacettepe Universitesi Hastaneleri Norooji AD Sihhiye, Ankara, Turkey
Hospital de Santo Antรณnio (Serv. Neurologia)
๐ต๐นLargo Professor Abel Salazar, Porto, Portugal
Dokuz Eylul Medical School, Department of Neurology
๐น๐ทNoroloji Anabilim Dali Inciralti Izmir, Izmir, Turkey
Blue Ridge Research Center at Roanoke Neurological Center
๐บ๐ธRoanoke, Virginia, United States
Coastal Neurology, PA
๐บ๐ธBeaufort, South Carolina, United States
Senior Adults Specialty Research
๐บ๐ธAustin, Texas, United States
Hiren Desai Medicine Professional Corporation
๐จ๐ฆWindsor, Ontario, Canada