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

Parkinson's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00134966
• Other study ID #: CELC200A2305
• Status: Completed
• Phase: Phase 3
• First received: August 23, 2005
• Last updated: May 15, 2017
• Start date: August 2005
• Est. completion date: September 2007

Study information

• Verified date: May 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.).

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 information / eligibility

• Status: Completed
• Enrollment: 493
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Countries where clinical trial is conducted

United States,  Canada,  Czechia,  Israel,  Italy,  Poland,  Portugal,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptom control change from baseline to week 39
Secondary	Change from baseline to week 39 in activities of daily living
Secondary	Change from baseline to week 39 in motor function
Secondary	Change from baseline to week 39 in mental acuity
Secondary	Change from baseline to week 39 in incidence of dyskinesia and wearing off

External Links

•   Clinical Trial Results for CELC200A2305 at Novartis Clinical Trials.com