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

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
capsules containing: carbidopa (25 mg), levodopa (100 mg), entacapone (200 mg)
Sponsored by
Novartis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's disease, levodopa, dyskinesia

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Barrow Neurology Clinics at St. Joseph's Hosptial & Medical Center
  • Coastal Neurological Medical Group, Inc
  • Neurosearch, Inc.
  • University of Florida Health Science Center
  • Mayo Clinic
  • USF Medical Clinic
  • Springfield Neurology Associates, LLC
  • Clinical Neuroscience Center
  • Melbourne Internal Medicine Associates
  • Westmoreland Neurology Associates, Inc.
  • Lankenau Hospital
  • NeuroHealth
  • Coastal Neurology, PA
  • Senior Adults Specialty Research
  • Baylor College of Medicine, Parkinson's Disease Center
  • Neurology Associates
  • Blue Ridge Research Center at Roanoke Neurological Center
  • Heritage Medical Research Clinic
  • Eastern Health Care - Health Sciences Centre, Neurology Department
  • Neurology Division, Health Science Center
  • Cape Breton Regional Hospital, Neurology Department
  • Grand River Hospital
  • London Health Sciences Center, University Hospital, Rm. A10-026
  • Centre for Movement Disorders
  • Parkinson's & Neurodegenerative Disorders Clinic
  • Ottawa Hospital, Civic Campus
  • Hiren Desai Medicine Professional Corporation
  • Neuro Rive Sud
  • Montreal General Hospital
  • Unite des Troubles du Mouvement Andre-Barbeau, CHUM-Hotel-Dieu
  • Centre de Recjerche Clinique du CHUS
  • Dr. Felix Veloso Research
  • Quebec Memory and Motor Skills Disorders Clinic
  • University of Saskatchewan, Royal University Hospital
  • Neurologická klinika, Univerzita Palackého
  • FN-neurologická klinika
  • Neurologicka klinika
  • FN-Nemocnice Pardubice
  • Rambam Medical Center
  • Dep. Of Neurology (Bitan 38, EEG institute)
  • Belinson Campus, Jabotinsky st. Movement Disorder Unit
  • Sourasky Medical Center
  • Clinica Neurologica I - Azienda Ospedaliera-Universitaria Policlinico - Università di Catania
  • "Dipartimento di Neuroscienze Oftalmologia e Genetica (DINOG)
  • Unità Operativa Complessa Neurologia - Policlinico Universitario "G. Martino"
  • Istituto Nazionale Neurologico "Carlo Besta"
  • Dipartimento di Neuroscienze-Sezione Neurologia Università degli Studi di Pisa- AO S. Chiara
  • Dipartimento di Scienze Neurologiche Università degli Studi di Roma "La Sapienza" Roma I
  • Dipartimento di Neuroscienze-Università degli Studi di Torino
  • A.O. Istituti Clinici di Perfezionamento-Unita'Operativa Centro Parkinson
  • Samodzielny Publiczny Szpital Kliniczny Oddzial Kliniczny Neurologii i Epiletologii
  • Centrum Neurologii Klinicznej
  • Klinika Neruologii Wieku Podeszlego
  • Hospitais da Universidade de Coimbra (Serv. Neurologia)
  • Hospital de Santa Maria (Serv. Neurologia)
  • Hospital de Santo António (Serv. Neurologia)
  • Istanbul CAPA Medical School
  • Hacettepe Medical School, Department of Neurology
  • Dokuz Eylul Medical School, Department of Neurology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Symptom control change from baseline to week 39

Secondary Outcome Measures

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

Full Information

First Posted
August 23, 2005
Last Updated
May 15, 2017
Sponsor
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00134966
Brief Title
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

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's disease, levodopa, dyskinesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
493 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
capsules containing: carbidopa (25 mg), levodopa (100 mg), entacapone (200 mg)
Other Intervention Name(s)
Stalevo, CELC200
Primary Outcome Measure Information:
Title
Symptom control change from baseline to week 39
Secondary Outcome Measure Information:
Title
Change from baseline to week 39 in activities of daily living
Title
Change from baseline to week 39 in motor function
Title
Change from baseline to week 39 in mental acuity
Title
Change from baseline to week 39 in incidence of dyskinesia and wearing off

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Barrow Neurology Clinics at St. Joseph's Hosptial & Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Coastal Neurological Medical Group, Inc
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Neurosearch, Inc.
City
Reseda
State/Province
California
ZIP/Postal Code
91335
Country
United States
Facility Name
University of Florida Health Science Center
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
USF Medical Clinic
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Springfield Neurology Associates, LLC
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01104
Country
United States
Facility Name
Clinical Neuroscience Center
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48034
Country
United States
Facility Name
Melbourne Internal Medicine Associates
City
Westlake
State/Province
Ohio
ZIP/Postal Code
44145
Country
United States
Facility Name
Westmoreland Neurology Associates, Inc.
City
Greensburg
State/Province
Pennsylvania
ZIP/Postal Code
15601
Country
United States
Facility Name
Lankenau Hospital
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096-3425
Country
United States
Facility Name
NeuroHealth
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Coastal Neurology, PA
City
Beaufort
State/Province
South Carolina
ZIP/Postal Code
29902
Country
United States
Facility Name
Senior Adults Specialty Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78757
Country
United States
Facility Name
Baylor College of Medicine, Parkinson's Disease Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Neurology Associates
City
San Marcos
State/Province
Texas
ZIP/Postal Code
78666
Country
United States
Facility Name
Blue Ridge Research Center at Roanoke Neurological Center
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
Heritage Medical Research Clinic
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N1
Country
Canada
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1C 2M4
Country
Canada
Facility Name
Eastern Health Care - Health Sciences Centre, Neurology Department
City
HSC Room 5317, 300 Prince Philip Drive, St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3V6
Country
Canada
Facility Name
Neurology Division, Health Science Center
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3J 3T1
Country
Canada
Facility Name
Cape Breton Regional Hospital, Neurology Department
City
Sydney
State/Province
Nova Scotia
ZIP/Postal Code
B1P 1P3
Country
Canada
Facility Name
Grand River Hospital
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2H 5Z8
Country
Canada
Facility Name
London Health Sciences Center, University Hospital, Rm. A10-026
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
Centre for Movement Disorders
City
Markham
State/Province
Ontario
ZIP/Postal Code
L6B 1C9
Country
Canada
Facility Name
Parkinson's & Neurodegenerative Disorders Clinic
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1G 4G3
Country
Canada
Facility Name
Ottawa Hospital, Civic Campus
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4E9
Country
Canada
Facility Name
Hiren Desai Medicine Professional Corporation
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8X 5A6
Country
Canada
Facility Name
Neuro Rive Sud
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2J2
Country
Canada
Facility Name
Montreal General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada
Facility Name
Unite des Troubles du Mouvement Andre-Barbeau, CHUM-Hotel-Dieu
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Centre de Recjerche Clinique du CHUS
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Dr. Felix Veloso Research
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4T 1A5
Country
Canada
Facility Name
Quebec Memory and Motor Skills Disorders Clinic
City
Quebec
ZIP/Postal Code
G1R 3X5
Country
Canada
Facility Name
University of Saskatchewan, Royal University Hospital
City
Saskatoon
ZIP/Postal Code
S7N 0W8
Country
Canada
Facility Name
Neurologická klinika, Univerzita Palackého
City
I.P.Pavlova 6
State/Province
Olomouc
ZIP/Postal Code
775 20
Country
Czechia
Facility Name
FN-neurologická klinika
City
Alej Svobody 80
State/Province
Plzeň
ZIP/Postal Code
304 60
Country
Czechia
Facility Name
Neurologicka klinika
City
Katerinska 12, Praha 2
ZIP/Postal Code
12000
Country
Czechia
Facility Name
FN-Nemocnice Pardubice
City
Kyjevska 44, Pardubice
ZIP/Postal Code
53000
Country
Czechia
Facility Name
Rambam Medical Center
City
Haliya Hashniya 8
State/Province
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Dep. Of Neurology (Bitan 38, EEG institute)
City
Dep. Of Neurology, Zerifin
ZIP/Postal Code
70300
Country
Israel
Facility Name
Belinson Campus, Jabotinsky st. Movement Disorder Unit
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Sourasky Medical Center
City
Weitzman St. Movement Disorder Clinic, Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Clinica Neurologica I - Azienda Ospedaliera-Universitaria Policlinico - Università di Catania
City
Via Santa Sofia 78
State/Province
Catania
ZIP/Postal Code
95123
Country
Italy
Facility Name
"Dipartimento di Neuroscienze Oftalmologia e Genetica (DINOG)
City
Università degli Studi di Genova, Via De Toni 5
State/Province
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Unità Operativa Complessa Neurologia - Policlinico Universitario "G. Martino"
City
Via Consolare Valeria
State/Province
Messina
ZIP/Postal Code
98125
Country
Italy
Facility Name
Istituto Nazionale Neurologico "Carlo Besta"
City
Via Celoria 11
State/Province
Milano
ZIP/Postal Code
20100
Country
Italy
Facility Name
Dipartimento di Neuroscienze-Sezione Neurologia Università degli Studi di Pisa- AO S. Chiara
City
Via Roma, 67
State/Province
Pisa
ZIP/Postal Code
56127
Country
Italy
Facility Name
Dipartimento di Scienze Neurologiche Università degli Studi di Roma "La Sapienza" Roma I
City
Viale dell'Università 30
State/Province
Roma
ZIP/Postal Code
00185
Country
Italy
Facility Name
Dipartimento di Neuroscienze-Università degli Studi di Torino
City
Via Cherasco 15
State/Province
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
A.O. Istituti Clinici di Perfezionamento-Unita'Operativa Centro Parkinson
City
Via Bignami 1, Milan
ZIP/Postal Code
20126
Country
Italy
Facility Name
Samodzielny Publiczny Szpital Kliniczny Oddzial Kliniczny Neurologii i Epiletologii
City
ul. Czerniakowska 231, Warszawa
ZIP/Postal Code
00-416
Country
Poland
Facility Name
Centrum Neurologii Klinicznej
City
Ul. Dwernickiego 8, Krakow
ZIP/Postal Code
31-530
Country
Poland
Facility Name
Klinika Neruologii Wieku Podeszlego
City
ul.Medykow 14, Katowice
ZIP/Postal Code
40-752
Country
Poland
Facility Name
Hospitais da Universidade de Coimbra (Serv. Neurologia)
City
Avenida Bissaya Barreto, Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
Hospital de Santa Maria (Serv. Neurologia)
City
Avenida Professor Egas Moniz, Lisbon
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Hospital de Santo António (Serv. Neurologia)
City
Largo Professor Abel Salazar, Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
Istanbul CAPA Medical School
City
Istanbul University CAPA Medical School, Dept. of Neurology
State/Province
Istanbul
ZIP/Postal Code
34610
Country
Turkey
Facility Name
Hacettepe Medical School, Department of Neurology
City
Hacettepe Universitesi Hastaneleri Norooji AD Sihhiye, Ankara
ZIP/Postal Code
6,100
Country
Turkey
Facility Name
Dokuz Eylul Medical School, Department of Neurology
City
Noroloji Anabilim Dali Inciralti Izmir, Izmir
ZIP/Postal Code
35340
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
19058133
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.
Results Reference
derived

Learn more about this trial

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

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