Stalevo in Early Wearing-Off Patients (SEWOP)

Orion Pharma

Status and phase: Completed; Phase 4

Conditions: Idiopathic Parkinson's Disease

Treatments: Drug: Stalevo (levodopa/carbidopa/entacapone); Drug: Levodopa/carbidopa

Study type: Interventional

Funder types: Industry

Identifiers

NCT00125567

EudraCT number: 2004-005234-39

2939111

Details and patient eligibility

About

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.

Enrollment: 223 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Idiopathic Parkinson's disease
• Treatment with 3 equal daily doses of levodopa/carbidopa up to 450 mg/day
• Unchanged antiparkinsonian medication for 6 weeks prior to baseline

Exclusion criteria

• Secondary or atypical parkinsonism
• Patients with daily unpredictable OFF periods or painful dyskinesia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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223 participants in 2 patient groups

1

Experimental group

Description:

Stalevo (levodopa/carbidopa/entacapone)

Treatment:

Drug: Stalevo (levodopa/carbidopa/entacapone)

2

Active Comparator group

Description:

Levodopa/carbidopa

Treatment:

Drug: Levodopa/carbidopa