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

May 15, 2017 updated by: Novartis

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

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.).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

493

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1R 3X5
        • Quebec Memory and Motor Skills Disorders Clinic
      • Saskatoon, Canada, S7N 0W8
        • University of Saskatchewan, Royal University Hospital
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N1
        • Heritage Medical Research Clinic
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C 2M4
    • Newfoundland and Labrador
      • HSC Room 5317, 300 Prince Philip Drive, St. John's, Newfoundland and Labrador, Canada, A1B 3V6
        • Eastern Health Care - Health Sciences Centre, Neurology Department
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3J 3T1
        • Neurology Division, Health Science Center
      • Sydney, Nova Scotia, Canada, B1P 1P3
        • Cape Breton Regional Hospital, Neurology Department
    • Ontario
      • Kitchener, Ontario, Canada, N2H 5Z8
        • Grand River Hospital
      • London, Ontario, Canada, N6A 5A5
        • London Health Sciences Center, University Hospital, Rm. A10-026
      • Markham, Ontario, Canada, L6B 1C9
        • Centre for Movement Disorders
      • Ottawa, Ontario, Canada, K1G 4G3
        • Parkinson's & Neurodegenerative Disorders Clinic
      • Ottawa, Ontario, Canada, K1Y 4E9
        • Ottawa Hospital, Civic Campus
      • Windsor, Ontario, Canada, N8X 5A6
        • Hiren Desai Medicine Professional Corporation
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2J2
        • Neuro Rive Sud
      • Montreal, Quebec, Canada, H3G 1A4
        • Montreal General Hospital
      • Montreal, Quebec, Canada
        • Unite des Troubles du Mouvement Andre-Barbeau, CHUM-Hotel-Dieu
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Centre de Recjerche Clinique du CHUS
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4T 1A5
        • Dr. Felix Veloso Research
  • Czechia
      • Katerinska 12, Praha 2, Czechia, 12000
        • Neurologicka klinika
      • Kyjevska 44, Pardubice, Czechia, 53000
        • FN-Nemocnice Pardubice
    • Olomouc
      • I.P.Pavlova 6, Olomouc, Czechia, 775 20
        • Neurologická klinika, Univerzita Palackého
    • Plzeň
      • Alej Svobody 80, Plzeň, Czechia, 304 60
        • FN-neurologická klinika
  • Israel
      • Dep. Of Neurology, Zerifin, Israel, 70300
        • Dep. Of Neurology (Bitan 38, EEG institute)
      • Petach Tikva, Israel, 49100
        • Belinson Campus, Jabotinsky st. Movement Disorder Unit
      • Weitzman St. Movement Disorder Clinic, Tel Aviv, Israel, 64239
        • Sourasky Medical Center
    • Haifa
      • Haliya Hashniya 8, Haifa, Israel, 31096
        • Rambam Medical Center
  • Italy
      • Via Bignami 1, Milan, Italy, 20126
        • A.O. Istituti Clinici di Perfezionamento-Unita'Operativa Centro Parkinson
    • Catania
      • Via Santa Sofia 78, Catania, Italy, 95123
        • Clinica Neurologica I - Azienda Ospedaliera-Universitaria Policlinico - Università di Catania
    • Genova
      • Università degli Studi di Genova, Via De Toni 5, Genova, Italy, 16132
        • "Dipartimento di Neuroscienze Oftalmologia e Genetica (DINOG)
    • Messina
      • Via Consolare Valeria, Messina, Italy, 98125
        • Unità Operativa Complessa Neurologia - Policlinico Universitario "G. Martino"
    • Milano
      • Via Celoria 11, Milano, Italy, 20100
        • Istituto Nazionale Neurologico "Carlo Besta"
    • Pisa
      • Via Roma, 67, Pisa, Italy, 56127
        • Dipartimento di Neuroscienze-Sezione Neurologia Università degli Studi di Pisa- AO S. Chiara
    • Roma
      • Viale dell'Università 30, Roma, Italy, 00185
        • Dipartimento di Scienze Neurologiche Università degli Studi di Roma "La Sapienza" Roma I
    • Torino
      • Via Cherasco 15, Torino, Italy, 10126
        • Dipartimento di Neuroscienze-Università degli Studi di Torino
  • Poland
      • Ul. Dwernickiego 8, Krakow, Poland, 31-530
        • Centrum Neurologii Klinicznej
      • ul. Czerniakowska 231, Warszawa, Poland, 00-416
        • Samodzielny Publiczny Szpital Kliniczny Oddzial Kliniczny Neurologii i Epiletologii
      • ul.Medykow 14, Katowice, Poland, 40-752
        • Klinika Neruologii Wieku Podeszlego
  • Portugal
      • Avenida Bissaya Barreto, Coimbra, Portugal, 3000-075
        • Hospitais da Universidade de Coimbra (Serv. Neurologia)
      • Avenida Professor Egas Moniz, Lisbon, Portugal, 1649-035
        • Hospital de Santa Maria (Serv. Neurologia)
      • Largo Professor Abel Salazar, Porto, Portugal, 4099-001
        • Hospital de Santo António (Serv. Neurologia)
  • Turkey
      • Hacettepe Universitesi Hastaneleri Norooji AD Sihhiye, Ankara, Turkey, 6,100
        • Hacettepe Medical School, Department of Neurology
      • Noroloji Anabilim Dali Inciralti Izmir, Izmir, Turkey, 35340
        • Dokuz Eylul Medical School, Department of Neurology
    • Istanbul
      • Istanbul University CAPA Medical School, Dept. of Neurology, Istanbul, Turkey, 34610
        • Istanbul CAPA Medical School
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Barrow Neurology Clinics at St. Joseph's Hosptial & Medical Center
    • California
      • La Jolla, California, United States, 92037
        • Coastal Neurological Medical Group, Inc
      • Reseda, California, United States, 91335
        • Neurosearch, Inc.
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic
      • Jacksonville, Florida, United States, 32209
        • University of Florida Health Science Center
      • Tampa, Florida, United States, 33612
        • USF Medical Clinic
    • Massachusetts
      • Springfield, Massachusetts, United States, 01104
        • Springfield Neurology Associates, LLC
    • Michigan
      • Southfield, Michigan, United States, 48034
        • Clinical Neuroscience Center
    • Ohio
      • Westlake, Ohio, United States, 44145
        • Melbourne Internal Medicine Associates
    • Pennsylvania
      • Greensburg, Pennsylvania, United States, 15601
        • Westmoreland Neurology Associates, Inc.
      • Wynnewood, Pennsylvania, United States, 19096-3425
        • Lankenau Hospital
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
        • Neurohealth
    • South Carolina
      • Beaufort, South Carolina, United States, 29902
        • Coastal Neurology, PA
    • Texas
      • Austin, Texas, United States, 78757
        • Senior Adults Specialty Research
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine, Parkinson's Disease Center
      • San Marcos, Texas, United States, 78666
        • Neurology Associates
    • Virginia
      • Roanoke, Virginia, United States, 24014
        • Blue Ridge Research Center at Roanoke Neurological Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 2
Drug: capsules containing: carbidopa (25 mg), levodopa (100 mg), entacapone (200 mg)
Other Names:
  • Stalevo
  • CELC200
EXPERIMENTAL: 1
Drug: capsules containing: carbidopa (25 mg), levodopa (100 mg), entacapone (200 mg)
Other Names:
  • Stalevo
  • CELC200

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Symptom control change from baseline to week 39

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Primary Completion (ACTUAL)

September 1, 2007

Study Completion (ACTUAL)

September 1, 2007

Study Registration Dates

First Submitted

August 23, 2005

First Submitted That Met QC Criteria

August 23, 2005

First Posted (ESTIMATE)

August 25, 2005

Study Record Updates

Last Update Posted (ACTUAL)

May 17, 2017

Last Update Submitted That Met QC Criteria

May 15, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CELC200A2305

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe