Status:

COMPLETED

Efficacy and Safety of Carbidopa/Levodopa/Entacapone in Patients With Parkinson's Disease Requiring Initiation of Levodopa Therapy

Lead Sponsor:

Novartis Pharmaceuticals

Collaborating Sponsors:

Orion Corporation, Orion Pharma

Conditions:

Parkinson's Disease

Eligibility:

All Genders

30-70 years

Phase:

PHASE3

Brief Summary

The CELC200A2401 study has been designed in order to evaluate the hypothesis that administering the combination carbidopa/levodopa/entacapone at the time that levodopa therapy is initiated results in ...

Eligibility Criteria

Inclusion

  • Clinical diagnosis of idiopathic Parkinson's disease
  • Diagnosis of Parkinson's disease for no more than 5 years

Exclusion

  • History, signs, or symptoms of atypical or secondary parkinsonism
  • Presence at baseline of drug-related wearing-off symptoms, dyskinesia or other motor complications
  • Levodopa exposure of more than 30 days or anytime within 8 weeks prior to visit 1
  • Other inclusion/exclusion criteria applied to this study.

Key Trial Info

Start Date :

September 1 2004

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 1 2008

Estimated Enrollment :

747 Patients enrolled

Trial Details

Trial ID

NCT00099268

Start Date

September 1 2004

End Date

November 1 2008

Last Update

April 23 2012

Active Locations (73)

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Page 1 of 19 (73 locations)

1

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35233

2

Mayo Clinic

Scottsdale, Arizona, United States, 85259

3

Coastal Neurological Medical Group

La Jolla, California, United States, 92037

4

Keck School of Medicine, Division of Movement Disorders

Los Angeles, California, United States, 90033