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

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ClinicalTrials.gov Identifier: NCT00134966
Recruitment Status : Completed
First Posted : August 25, 2005
Last Update Posted : May 17, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis

Brief 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.).

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: capsules containing: carbidopa (25 mg), levodopa (100 mg), entacapone (200 mg) Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 493 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : August 2005
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Symptom control change from baseline to week 39

Secondary Outcome Measures :
  1. Change from baseline to week 39 in activities of daily living
  2. Change from baseline to week 39 in motor function
  3. Change from baseline to week 39 in mental acuity
  4. Change from baseline to week 39 in incidence of dyskinesia and wearing off


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00134966


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Sponsors and Collaborators
Novartis

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00134966     History of Changes
Other Study ID Numbers: CELC200A2305
First Posted: August 25, 2005    Key Record Dates
Last Update Posted: May 17, 2017
Last Verified: May 2017

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
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Aromatic Amino Acid Decarboxylase Inhibitors
Enzyme Inhibitors
Catechol O-Methyltransferase Inhibitors
Adjuvants, Immunologic
Immunologic Factors
Dopamine Agonists