A Study to Evaluate Fixed Dose Carbidopa/Levodopa/Entacapone Versus Immediate Release Carbidopa/Levodopa - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00134966

Purpose

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.).

Condition	Intervention	Phase
Parkinson's Disease	Drug: capsules containing: carbidopa (25 mg), levodopa (100 mg), entacapone (200 mg)	Phase III

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Parkinson's Disease

Drug Information available for: Levodopa Carbidopa OR 611 Entacapone

U.S. FDA Resources

Study Type:

Interventional

Study Design:

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

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

Further study details as provided by Novartis:

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

Enrollment:	493
Study Start Date:	August 2005
Study Completion Date:	September 2007

Arms	Assigned Interventions
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)

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.

Eligibility

Ages Eligible for Study:	30 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00134966

Show 61 Study Locations

Sponsors and Collaborators

Novartis

More Information

Additional Information:

Click here for more information about this study This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Novartis Pharmaceuticals ( External Affairs )
Study ID Numbers:	CELC200A2305
Study First Received:	August 23, 2005
Last Updated:	March 28, 2008
ClinicalTrials.gov Identifier:	NCT00134966 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Parkinson's disease, levodopa, dyskinesia

Study placed in the following topic categories:

Neurotransmitter Agents
Levodopa
Ganglion Cysts
Immunologic Factors
Basal Ganglia Diseases
Carbidopa
Adjuvants, Immunologic
Central Nervous System Diseases
Dopamine Agonists
Brain Diseases

Neurodegenerative Diseases
Dyskinesias
Entacapone
Dopamine
Parkinson Disease
Movement Disorders
Sinemet
Dopamine Agents
Parkinsonian Disorders

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Anti-Dyskinesia Agents
Basal Ganglia Diseases
Physiological Effects of Drugs
Antiparkinson Agents
Neurodegenerative Diseases
Brain Diseases
Dopamine Agonists
Movement Disorders
Therapeutic Uses
Levodopa

Carbidopa
Nervous System Diseases
Adjuvants, Immunologic
Central Nervous System Diseases
Enzyme Inhibitors
Pharmacologic Actions
Entacapone
Parkinson Disease
Sinemet
Dopamine Agents
Parkinsonian Disorders
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009