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Completed Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT00134966

Public ClinicalTrials.gov record NCT00134966. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 1, 2026, 7:44 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT00134966
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Novartis
Industry
Enrollment
493 participants

Conditions and interventions

Eligibility (public fields only)

Age range
30 Years to 80 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 31, 2005
Primary completion
Aug 31, 2007
Completion
Aug 31, 2007
Last update posted
May 16, 2017

2005 – 2007

United States locations

U.S. sites
17
U.S. states
11
U.S. cities
16
Facility City State ZIP Site status
Barrow Neurology Clinics at St. Joseph's Hosptial & Medical Center Phoenix Arizona 85013
Coastal Neurological Medical Group, Inc La Jolla California 92037
Neurosearch, Inc. Reseda California 91335
University of Florida Health Science Center Jacksonville Florida 32209
Mayo Clinic Jacksonville Florida 32224
USF Medical Clinic Tampa Florida 33612
Springfield Neurology Associates, LLC Springfield Massachusetts 01104
Clinical Neuroscience Center Southfield Michigan 48034
Melbourne Internal Medicine Associates Westlake Ohio 44145
Westmoreland Neurology Associates, Inc. Greensburg Pennsylvania 15601
Lankenau Hospital Wynnewood Pennsylvania 19096-3425
NeuroHealth Warwick Rhode Island 02886
Coastal Neurology, PA Beaufort South Carolina 29902
Senior Adults Specialty Research Austin Texas 78757
Baylor College of Medicine, Parkinson's Disease Center Houston Texas 77030
Neurology Associates San Marcos Texas 78666
Blue Ridge Research Center at Roanoke Neurological Center Roanoke Virginia 24014

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 43 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00134966, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 16, 2017 · Synced Sep 1, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00134966 live on ClinicalTrials.gov.

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