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

• Status: Completed
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

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 a decrease in the risk of the development of motor complications for patients with Parkinson's disease.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Collaborator: Orion Corporation, Orion Pharma
• Treatments: Carbidopa; Carbidopa, levodopa drug combination; Entacapone; Levodopa

Criteria

Inclusion Criteria:

• Clinical diagnosis of idiopathic Parkinson's disease

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

Exclusion Criteria:

• 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.