Clinical trial NCT00134966: A Study to Evaluate Fixed Dose Carbidopa/Levodopa/Entacapone Versus Immediate Release Carbidopa/Levodopa
Official title: A 39 Week Randomized, Double-Blind, Parallel Group, Multicenter Study to Evaluate the Effect of Fixed Dose Carbidopa/Levodopa/Entacapone 100 mg t.i.d. vs. Immediate Release Carbidopa/Levodopa 25/100 mg (t.i.d.) in Parkinson's Disease Patients Requiring Levodopa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parkinson's Disease
Keywords: Parkinson's disease, levodopa, dyskinesia
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-08-25
Enrollment: 493
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Symptom control change from baseline to week 39
Secondary outcomes:
measure: Change from baseline to week 39 in activities of daily living
measure: Change from baseline to week 39 in motor function
measure: Change from baseline to week 39 in mental acuity
measure: Change from baseline to week 39 in incidence of dyskinesia and wearing off
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Barrow Neurology Clinics at St. Joseph's Hosptial & Medical Center
state: Arizona
city: La Jolla
country: United States
facility: Coastal Neurological Medical Group, Inc
state: California
city: Reseda
country: United States
facility: Neurosearch, Inc.
state: California
city: Jacksonville
country: United States
facility: University of Florida Health Science Center
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Tampa
country: United States
facility: USF Medical Clinic
state: Florida
city: Springfield
country: United States
facility: Springfield Neurology Associates, LLC
state: Massachusetts
city: Southfield
country: United States
facility: Clinical Neuroscience Center
state: Michigan
city: Westlake
country: United States
facility: Melbourne Internal Medicine Associates
state: Ohio
city: Greensburg
country: United States
facility: Westmoreland Neurology Associates, Inc.
state: Pennsylvania
city: Wynnewood
country: United States
facility: Lankenau Hospital
state: Pennsylvania
city: Warwick
country: United States
facility: NeuroHealth
state: Rhode Island
city: Beaufort
country: United States
facility: Coastal Neurology, PA
state: South Carolina
city: Austin
country: United States
facility: Senior Adults Specialty Research
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine, Parkinson's Disease Center
state: Texas
city: San Marcos
country: United States
facility: Neurology Associates
state: Texas
city: Roanoke
country: United States
facility: Blue Ridge Research Center at Roanoke Neurological Center
state: Virginia
city: Calgary
country: Canada
facility: Heritage Medical Research Clinic
state: Alberta
city: Moncton
country: Canada
state: New Brunswick
city: HSC Room 5317, 300 Prince Philip Drive, St. John's
country: Canada
facility: Eastern Health Care - Health Sciences Centre, Neurology Department
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: Neurology Division, Health Science Center
state: Nova Scotia
city: Sydney
country: Canada
facility: Cape Breton Regional Hospital, Neurology Department
state: Nova Scotia
city: Kitchener
country: Canada
facility: Grand River Hospital
state: Ontario
city: London
country: Canada
facility: London Health Sciences Center, University Hospital, Rm. A10-026
state: Ontario
city: Markham
country: Canada
facility: Centre for Movement Disorders
state: Ontario
city: Ottawa
country: Canada
facility: Parkinson's & Neurodegenerative Disorders Clinic
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital, Civic Campus
state: Ontario
city: Windsor
country: Canada
facility: Hiren Desai Medicine Professional Corporation
state: Ontario
city: Greenfield Park
country: Canada
facility: Neuro Rive Sud
state: Quebec
city: Montreal
country: Canada
facility: Montreal General Hospital
state: Quebec
city: Montreal
country: Canada
facility: Unite des Troubles du Mouvement Andre-Barbeau, CHUM-Hotel-Dieu
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre de Recjerche Clinique du CHUS
state: Quebec
city: Regina
country: Canada
facility: Dr. Felix Veloso Research
state: Saskatchewan
city: Quebec
country: Canada
facility: Quebec Memory and Motor Skills Disorders Clinic
city: Saskatoon
country: Canada
facility: University of Saskatchewan, Royal University Hospital
city: I.P.Pavlova 6
country: Czechia
facility: Neurologická klinika, Univerzita Palackého
state: Olomouc
city: Alej Svobody 80
country: Czechia
facility: FN-neurologická klinika
state: Plzeň
city: Katerinska 12, Praha 2
country: Czechia
facility: Neurologicka klinika
city: Kyjevska 44, Pardubice
country: Czechia
facility: FN-Nemocnice Pardubice
city: Haliya Hashniya 8
country: Israel
facility: Rambam Medical Center
state: Haifa
city: Dep. Of Neurology, Zerifin
country: Israel
facility: Dep. Of Neurology (Bitan 38, EEG institute)
city: Petach Tikva
country: Israel
facility: Belinson Campus, Jabotinsky st. Movement Disorder Unit
city: Weitzman St. Movement Disorder Clinic, Tel Aviv
country: Israel
facility: Sourasky Medical Center
city: Via Santa Sofia 78
country: Italy
facility: Clinica Neurologica I - Azienda Ospedaliera-Universitaria Policlinico - Università di Catania
state: Catania
city: Università degli Studi di Genova, Via De Toni 5
country: Italy
facility: "Dipartimento di Neuroscienze Oftalmologia e Genetica (DINOG)
state: Genova
city: Via Consolare Valeria
country: Italy
facility: Unità Operativa Complessa Neurologia - Policlinico Universitario "G. Martino"
state: Messina
city: Via Celoria 11
country: Italy
facility: Istituto Nazionale Neurologico "Carlo Besta"
state: Milano
city: Via Roma, 67
country: Italy
facility: Dipartimento di Neuroscienze-Sezione Neurologia Università degli Studi di Pisa- AO S. Chiara
state: Pisa
city: Viale dell'Università 30
country: Italy
facility: Dipartimento di Scienze Neurologiche Università degli Studi di Roma "La Sapienza" Roma I
state: Roma
city: Via Cherasco 15
country: Italy
facility: Dipartimento di Neuroscienze-Università degli Studi di Torino
state: Torino
city: Via Bignami 1, Milan
country: Italy
facility: A.O. Istituti Clinici di Perfezionamento-Unita'Operativa Centro Parkinson
city: ul. Czerniakowska 231, Warszawa
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny Oddzial Kliniczny Neurologii i Epiletologii
city: Ul. Dwernickiego 8, Krakow
country: Poland
facility: Centrum Neurologii Klinicznej
city: ul.Medykow 14, Katowice
country: Poland
facility: Klinika Neruologii Wieku Podeszlego
city: Avenida Bissaya Barreto, Coimbra
country: Portugal
facility: Hospitais da Universidade de Coimbra (Serv. Neurologia)
city: Avenida Professor Egas Moniz, Lisbon
country: Portugal
facility: Hospital de Santa Maria (Serv. Neurologia)
city: Largo Professor Abel Salazar, Porto
country: Portugal
facility: Hospital de Santo António (Serv. Neurologia)
city: Istanbul University CAPA Medical School, Dept. of Neurology
country: Turkey
facility: Istanbul CAPA Medical School
state: Istanbul
city: Hacettepe Universitesi Hastaneleri Norooji AD Sihhiye, Ankara
country: Turkey
facility: Hacettepe Medical School, Department of Neurology
city: Noroloji Anabilim Dali Inciralti Izmir, Izmir
country: Turkey
facility: Dokuz Eylul Medical School, Department of Neurology
Study officials:
References:
citation: 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.