drugset
drugset / Trial / NCT00125567

Stalevo in Early Wearing-Off Patients

NCT00125567 ↗

Phase 4 Completed 223 enrolled Orion Corporation, Orion Pharma
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to demonstrate in patients with Parkinson's disease that, when compared to levodopa/carbidopa, Stalevo will delay the time from initiation of study drug to the time an increase in antiparkinsonian medication is required due to inadequately controlled parkinsonian symptoms.

Timeline

Start
2005-08
Primary completion
2009-03
Completion
2009-03

Outcome

Met primary endpoint

release “Positive primary endpoint from FIRST-STEP study with Stalevo® in early Parkinson's Disease” orionpharma.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Levodopa/carbidopa Unknown 50 mg Oral
Comparator Levodopa/carbidopa Unknown 150 mg Oral
Subject levodopa/carbidopa/entacapone Unknown 50 mg Oral
Subject levodopa/carbidopa/entacapone Unknown 150 mg Oral

Indications

Parkinson disease