Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-005234-39-GB

Enrollment

240

Registered

2005-03-22

Start date

2005-05-27

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's disease MedDRA version: 7.0 Level: LLT Classification code 10061536

Interventions

Trade Name: Stalevo Product Name: Stalevo Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Levodopa Concentration unit: mg m

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Male or female patients • Patients with idiopathic Parkinson’s disease and end-of-dose motor-fluctuations not stabilized on their current levodopa/DDCI treatment • Hoehn and Yahr stage 1-3 performed during the “ON” state • Treatment with 3 equal or unequal daily doses of standard-release levodopa/DDCI up to a maximum total daily levodopa dose of 450 mg. • Unchanged levodopa/DDCI and other antiparkinsonian medication (amantadine, MAO-B inhibitor with an approved dose, anticholinergics and/or dopamine agonists), if any, for at least 6 weeks prior to baseline visit • Age: 30 years or above Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Secondary or atypical parkinsonism • Patients with daily unpredictable “OFF”-periods or painful dyskinesia (including painful dystonia) • Previous or current treatment with a COMT inhibitor • Current treatment with controlled-release or extended-release levodopa/DDCI preparations, except one evening (8-12pm) dose of a CR levodopa preparation to control night time symptoms is allowed. • Patients requiring rescue medication (including soluble levodopa formulations)

Design outcomes

Primary

Measure	Time frame
Main Objective: To demonstrate the superiority of Stalevo® treatment to levodopa/carbidopa treatment in delaying the time from initiation of study drug to patients requiring an increase in antiparkinsonian therapy due to inadequately controlled Parkinsonian symptoms level.;Secondary Objective: To study the effects of Stalevo® on patient’s condition, quality of life and on patients’ plasma homocysteine;Primary end point(s): The time from initiation of study drug to patients requiring an increase in antiparkinsonian therapy due to inadequately controlled Parkinsonian symptoms	—

Measure

Time frame

Main Objective: To demonstrate the superiority of Stalevo® treatment to levodopa/carbidopa treatment in delaying the time from initiation of study drug to patients requiring an increase in antiparkinsonian therapy due to inadequately controlled Parkinsonian symptoms level.;Secondary Objective: To study the effects of Stalevo® on patient’s condition, quality of life and on patients’ plasma homocysteine;Primary end point(s): The time from initiation of study drug to patients requiring an increase in antiparkinsonian therapy due to inadequately controlled Parkinsonian symptoms

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Countries

Denmark, Finland, Germany, Ireland, Latvia, Lithuania, Sweden, United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026