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

This study has been completed.

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   

ChemIDplus related topics:   Entacapone    Levodopa    Carbidopa    OR 611   

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  Show 61 Study Locations

Sponsors and Collaborators
Novartis
  More Information


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

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

Keywords provided by Novartis:
Parkinson's disease, levodopa, dyskinesia  

Study placed in the following topic categories:
Levodopa
Ganglion Cysts
Basal Ganglia Diseases
Carbidopa
Central Nervous System Diseases
Brain Diseases
Neurodegenerative Diseases
Dyskinesias
Entacapone
Dopamine
Parkinson Disease
Movement Disorders
Sinemet
Parkinsonian Disorders

Additional relevant MeSH terms:
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Anti-Dyskinesia Agents
Nervous System Diseases
Physiological Effects of Drugs
Adjuvants, Immunologic
Antiparkinson Agents
Enzyme Inhibitors
Dopamine Agonists
Pharmacologic Actions
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 17, 2008




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