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Completed

NCT Number: NCT00125567

Stalevo in Early Wearing-Off Patients

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.

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Key information

Conditions

IDIOPATHIC PARKINSON'S DISEASE Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Aalborg Hospital, Aalborg, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stalevo (levodopa/carbidopa/entacapone)

Drug

Oral, 50-150 mg levodopa four times daily, for up to 2 years

Levodopa/carbidopa

Drug

Oral capsules, 50-150 mg levodopa four times daily, for up to 2 years

Primary outcomes

  1. The time until a patient requires changes in antiparkinsonian therapy due to inadequately controlled parkinsonian symptoms

    Time frame: Up to 2 years of treatment

Secondary outcomes

  1. Unified Parkinson's Disease Rating Scale

    Time frame: Up to 2 years of treatment

  2. Clinical Global Impression of Change (investigator)

    Time frame: Up to 2 years of treatment

  3. Parkinson's Disease Questionnaire (PDQ-39)

    Time frame: Up to 2 years of treatment

  4. Work Impairment Questionnaire

    Time frame: Up to 2 years of treatment

Sponsors and collaborators

Lead sponsor

Orion Corporation, Orion Pharma

Industry

Registry information

Official study title

Multicentre, Randomised, Double-Blind Study to Compare Stalevo to Levodopa/Carbidopa in Patients With Parkinson's Disease Experiencing Symptoms of Early Wearing-Off

Acronym: SEWOP

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Aug 1, 2005
Registry last updated
Jun 22, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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