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Completed

NCT Number: NCT00134966

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

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.).

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Dyskinesias Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Parkinson Disease Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Synucleinopathies

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Heritage Medical Research Clinic, Calgary, Alberta, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

capsules containing: carbidopa (25 mg), levodopa (100 mg), entacapone (200 mg)

Drug

Other names: Stalevo, CELC200

Primary outcomes

  1. Symptom control change from baseline to week 39

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Aug 25, 2005
Registry last updated
May 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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