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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00134966
First received: August 23, 2005
Last updated: March 28, 2008
Last verified: March 2008
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


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
Experimental: 1 Drug: capsules containing: carbidopa (25 mg), levodopa (100 mg), entacapone (200 mg)
Other Names:
  • Stalevo
  • CELC200
Active Comparator: 2 Drug: capsules containing: carbidopa (25 mg), levodopa (100 mg), entacapone (200 mg)
Other Names:
  • Stalevo
  • CELC200

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 60 Study Locations
Sponsors and Collaborators
Novartis
  More Information

Additional Information:
No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00134966     History of Changes
Other Study ID Numbers: CELC200A2305
Study First Received: August 23, 2005
Last Updated: March 28, 2008
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Levodopa
Carbidopa
Entacapone
Carbidopa, levodopa drug combination
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Enzyme Inhibitors
Adjuvants, Immunologic
Immunologic Factors
Dopamine Agonists

ClinicalTrials.gov processed this record on September 16, 2014