A Study to Evaluate Fixed Dose Carbidopa/Levodopa/Entacapone Versus Immediate Release Carbidopa/Levodopa

NCT00134966 | Completed Phase 3

• 1 other identifier: CELC200A2305
• Study Type: interventional
• Target: 493
• Locations: 8 countries
• Sites: 60

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.).

Conditions

Parkinson's Disease

Keywords

Parkinson's disease, levodopa, dyskinesia

Outcome Measures

Primary Outcomes (1)

• Symptom control change from baseline to week 39

Secondary Outcomes (4)

• Change from baseline to week 39 in activities of daily living

• Change from baseline to week 39 in motor function

• Change from baseline to week 39 in mental acuity

• Change from baseline to week 39 in incidence of dyskinesia and wearing off

Study Arms (2)

1

EXPERIMENTAL

Drug: capsules containing: carbidopa (25 mg), levodopa (100 mg), entacapone (200 mg)

2

ACTIVE COMPARATOR

Drug: capsules containing: carbidopa (25 mg), levodopa (100 mg), entacapone (200 mg)

Interventions

capsules containing: carbidopa (25 mg), levodopa (100 mg), entacapone (200 mg) DRUG

Also known as: Stalevo, CELC200

1; 2

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis: lead

Study Sites (60)

Barrow Neurology Clinics at St. Joseph's Hosptial & Medical Center

Phoenix, Arizona, 85013, United States

Location

Coastal Neurological Medical Group, Inc

La Jolla, California, 92037, United States

Location

Neurosearch, Inc.

Reseda, California, 91335, United States

Location

University of Florida Health Science Center

Jacksonville, Florida, 32209, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

USF Medical Clinic

Tampa, Florida, 33612, United States

Location

Springfield Neurology Associates, LLC

Springfield, Massachusetts, 01104, United States

Location

Clinical Neuroscience Center

Southfield, Michigan, 48034, United States

Location

Melbourne Internal Medicine Associates

Westlake, Ohio, 44145, United States

Location

Westmoreland Neurology Associates, Inc.

Greensburg, Pennsylvania, 15601, United States

Location

Lankenau Hospital

Wynnewood, Pennsylvania, 19096-3425, United States

Location

NeuroHealth

Warwick, Rhode Island, 02886, United States

Location

Coastal Neurology, PA

Beaufort, South Carolina, 29902, United States

Location

Senior Adults Specialty Research

Austin, Texas, 78757, United States

Location

Baylor College of Medicine, Parkinson's Disease Center

Houston, Texas, 77030, United States

Location

Neurology Associates

San Marcos, Texas, 78666, United States

Location

Blue Ridge Research Center at Roanoke Neurological Center

Roanoke, Virginia, 24014, United States

Location

Heritage Medical Research Clinic

Calgary, Alberta, T2N 4N1, Canada

Location

Unknown Facility

Moncton, New Brunswick, E1C 2M4, Canada

Location

Eastern Health Care - Health Sciences Centre, Neurology Department

HSC Room 5317, 300 Prince Philip Drive, Saint John's, Newfoundland and Labrador, A1B 3V6, Canada

Location

Neurology Division, Health Science Center

Halifax, Nova Scotia, B3J 3T1, Canada

Location

Cape Breton Regional Hospital, Neurology Department

Sydney, Nova Scotia, B1P 1P3, Canada

Location

Grand River Hospital

Kitchener, Ontario, N2H 5Z8, Canada

Location

London Health Sciences Center, University Hospital, Rm. A10-026

London, Ontario, N6A 5A5, Canada

Location

Centre for Movement Disorders

Markham, Ontario, L6B 1C9, Canada

Location

Parkinson's & Neurodegenerative Disorders Clinic

Ottawa, Ontario, K1G 4G3, Canada

Location

Ottawa Hospital, Civic Campus

Ottawa, Ontario, K1Y 4E9, Canada

Location

Hiren Desai Medicine Professional Corporation

Windsor, Ontario, N8X 5A6, Canada

Location

Neuro Rive Sud

Greenfield Park, Quebec, J4V 2J2, Canada

Location

Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

Location

Unite des Troubles du Mouvement Andre-Barbeau, CHUM-Hotel-Dieu

Montreal, Quebec, Canada

Location

Centre de Recjerche Clinique du CHUS

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Dr. Felix Veloso Research

Regina, Saskatchewan, S4T 1A5, Canada

Location

Quebec Memory and Motor Skills Disorders Clinic

Québec, G1R 3X5, Canada

Location

University of Saskatchewan, Royal University Hospital

Saskatoon, S7N 0W8, Canada

Location

Neurologická klinika, Univerzita Palackého

I.P.Pavlova 6, Olomouc, 775 20, Czechia

Location

FN-neurologická klinika

Alej Svobody 80, Plzeň, 304 60, Czechia

Location

Neurologicka klinika

Katerinska 12, Praha 2, 12000, Czechia

Location

FN-Nemocnice Pardubice

Kyjevska 44, Pardubice, 53000, Czechia

Location

Rambam Medical Center

Haliya Hashniya 8, Haifa District, 31096, Israel

Location

Dep. Of Neurology (Bitan 38, EEG institute)

Dep. of Neurology, Zerifin, 70300, Israel

Location

Belinson Campus, Jabotinsky st. Movement Disorder Unit

Petah Tikva, 49100, Israel

Location

Sourasky Medical Center

Weitzman Saint Movement Disorder Clinic, Tel Aviv, 64239, Israel

Location

Clinica Neurologica I - Azienda Ospedaliera-Universitaria Policlinico - Università di Catania

Via Santa Sofia 78, Catania, 95123, Italy

Location

"Dipartimento di Neuroscienze Oftalmologia e Genetica (DINOG)

Università Degli Studi Di Genova, Via de Toni 5, Genova, 16132, Italy

Location

Unità Operativa Complessa Neurologia - Policlinico Universitario "G. Martino"

Via Consolare Valeria, Messina, 98125, Italy

Location

Istituto Nazionale Neurologico "Carlo Besta"

Via Celoria 11, Milano, 20100, Italy

Location

Dipartimento di Neuroscienze-Sezione Neurologia Università degli Studi di Pisa- AO S. Chiara

Via Roma, 67, Pisa, 56127, Italy

Location

Dipartimento di Scienze Neurologiche Università degli Studi di Roma "La Sapienza" Roma I

Viale dell'Università 30, Roma, 00185, Italy

Location

Dipartimento di Neuroscienze-Università degli Studi di Torino

Via Cherasco 15, Torino, 10126, Italy

Location

A.O. Istituti Clinici di Perfezionamento-Unita'Operativa Centro Parkinson

Via Bignami 1, Milan, 20126, Italy

Location

Samodzielny Publiczny Szpital Kliniczny Oddzial Kliniczny Neurologii i Epiletologii

Ul. Czerniakowska 231, Warszawa, 00-416, Poland

Location

Centrum Neurologii Klinicznej

Ul. Dwernickiego 8, Krakow, 31-530, Poland

Location

Klinika Neruologii Wieku Podeszlego

ul.Medykow 14, Katowice, 40-752, Poland

Location

Hospitais da Universidade de Coimbra (Serv. Neurologia)

Avenida Bissaya Barreto, Coimbra, 3000-075, Portugal

Location

Hospital de Santa Maria (Serv. Neurologia)

Avenida Professor Egas Moniz, Lisbon, 1649-035, Portugal

Location

Hospital de Santo António (Serv. Neurologia)

Largo Professor Abel Salazar, Porto, 4099-001, Portugal

Location

Istanbul CAPA Medical School

Istanbul University CAPA Medical School, Dept. of Neurology, Istanbul, 34610, Turkey (Türkiye)

Location

Hacettepe Medical School, Department of Neurology

Hacettepe Universitesi Hastaneleri Norooji AD Sihhiye, Ankara, 6,100, Turkey (Türkiye)

Location

Dokuz Eylul Medical School, Department of Neurology

Noroloji Anabilim Dali Inciralti Izmir, Izmir, 35340, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 19058133 DERIVED

MeSH Terms

Conditions

Parkinson Disease; Dyskinesias

Interventions

Levodopa; entacapone; Stalevo

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dihydroxyphenylalanine; Catecholamines; Amines; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Tyrosine

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2005
• First Posted: August 25, 2005
• Study Start: August 1, 2005
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: May 17, 2017

Record last verified: 2017-05

Locations

CA (18); CZ (4); PT (3); IL (4); US (17); IT (8); TU (3); PL (3)