NCT00391898

Efficacy of Levodopa/Carbidopa/Entacapone vs Levodopa/Carbidopa in Parkinson's Disease Patients With Early Wearing-off

A 3-month, Multi-center, Double-blind, Randomized Study to Evaluate the Efficacy of Levodopa/Carbidopa/Entacapone vs Levodopa/Carbidopa in Parkinson's Disease Patients With Impairment of Activities of Daily Living and Early Wearing-off With Levodopa

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The study evaluated the efficacy of levodopa/carbidopa/entacapone vs levodopa/carbidopa in patients with Parkinson's disease and early wearing-off with levodopa

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
DRUG	Levodopa/carbidopa/entacapone	Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa/entacapone was available in 2 oral dosage forms: 100/25/200 or 150/37.5/200 mg encapsulated tablets.
DRUG	Levodopa/carbidopa	Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa was available in 2 oral dosage forms: One or one and one-half 100/25 mg encapsulated tablets.

Timeline

• Start date: 2006-10-01
• Primary completion: 2008-06-01
• Completion: 2008-06-01
• First posted: 2006-10-25
• Last updated: 2011-03-15
• Results posted: 2011-03-15

Locations

26 sites across 1 country: Spain