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Stalevo in Early Wearing-Off Patients (SEWOP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00125567
Recruitment Status : Completed
First Posted : August 1, 2005
Last Update Posted : June 22, 2009
Information provided by:
Orion Corporation, Orion Pharma

Brief 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.

Condition or disease Intervention/treatment Phase
Idiopathic Parkinson's Disease Drug: Stalevo (levodopa/carbidopa/entacapone) Drug: Levodopa/carbidopa Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 223 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multicentre, Randomised, Double-Blind Study to Compare Stalevo to Levodopa/Carbidopa in Patients With Parkinson's Disease Experiencing Symptoms of Early Wearing-Off
Study Start Date : August 2005
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Stalevo (levodopa/carbidopa/entacapone)
Drug: Stalevo (levodopa/carbidopa/entacapone)
Oral, 50-150 mg levodopa four times daily, for up to 2 years

Active Comparator: 2
Drug: Levodopa/carbidopa
Oral capsules, 50-150 mg levodopa four times daily, for up to 2 years

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00125567

Show Show 19 study locations
Sponsors and Collaborators
Orion Corporation, Orion Pharma
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Study Director: Andrew Wighton, BSc (Hons) Orion Corporation, Orion Pharma
Principal Investigator: Bhadravati SD Sastry, FRCP University Hospital of Wales and Rookwood Hospital
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Responsible Party: Andrew Wighton, Orion Pharma Identifier: NCT00125567    
Other Study ID Numbers: 2939111
EudraCT number: 2004-005234-39
First Posted: August 1, 2005    Key Record Dates
Last Update Posted: June 22, 2009
Last Verified: June 2009
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Aromatic Amino Acid Decarboxylase Inhibitors
Enzyme Inhibitors
Catechol O-Methyltransferase Inhibitors