Study to Evaluate Initiation of Stalevo in Early Wearing-off
NCT ID: NCT00462007
Last Updated: 2015-04-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
115 participants
INTERVENTIONAL
2006-09-30
2007-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
Stalevo
Stalevo
Oral 3-4 daily doses for 6 weeks
Interventions
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Stalevo
Oral 3-4 daily doses for 6 weeks
Eligibility Criteria
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Inclusion Criteria
* Age \>35 - years
* Hoehn and Yahr stage 1-3 performed during the 'ON'-stage
* At least 1 symptom identified by WOQ-9
* Dosing frequency of 3-4 doses of standard-release levodopa/DDCI (maximum total daily dose of 600 mg of levodopa)
Exclusion Criteria
* Unpredictable OFF-periods
* Any peak-dose dyskinesia. 'OFF'-state dystonia is allowed
* Use of any rescue medications to treat symptoms of 'OFF'-state. 1 dose of soluble levodopa/DDCI is allowed.
* Concomitant treatment with non-selective monoamine oxidase (MAO) inhibitor or simultaneous use of higher than recommended doses of MAO-A and MAO-B inhibitors (selegiline 10 mg or rasagiline 1 mg allowed) or use of apomorphine.
35 Years
ALL
No
Sponsors
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Orion Corporation, Orion Pharma
INDUSTRY
Responsible Party
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Orion Pharma
Principal Investigators
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Wolfgang H. Oertel, Professor
Role: PRINCIPAL_INVESTIGATOR
Universitätsklinikum Giessen und Marburg GmbH
Locations
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Humboldt Universität Charité Neurologische Klinik
Berlin, , Germany
St. Josef-Hospital, Klinikum der Ruhr-Universität-Bochum Neurologische Klinik
Bochum, , Germany
Pharmakologisches Studienzentrum Chemnitz
Chemnitz, , Germany
Nervenarztpraxis Dr Alexander Nass
Cologne, , Germany
Universitätsklinikum Carl Gustav Carus Klinik und Poliklinik für Neurologie
Dresden, , Germany
Gemeinschaftspraxis für Neurologie & Psychiatrie
Erbach im Odenwald, , Germany
Neurologische Praxis Dr Christine Schuster
Giessen, , Germany
Universitätskrankenhaus Eppendorf
Hamburg, , Germany
Paracelsus-Elena Klinik
Kassel, , Germany
Alexianer-Krankenhaus
Krefeld, , Germany
Universitätsklinikum Gießen und Marburg GmbH
Marburg, , Germany
Asklepios Fachklinikum Stadtroda
Stadtroda, , Germany
Eberhard-Karls-Universität, Universitätsklinikum Tübingen, Zentrum für Neurologie
Tübingen, , Germany
Neurologische Klinik der Universität Ulm
Ulm, , Germany
Länsjukhuset Ryhov, Geriatriska Kliniken
Jönköping, , Sweden
Nyköpings Lasarett, Ger/Rehabkliniken
Nyköping, , Sweden
Visby lasarett, Neurologmottagningen
Visby, , Sweden
The Royal Bournemouth Hospital, Department of Medicines for the Elderly
Bournemouth, Dorset, United Kingdom
North Tyneside General Hospital, Department of Medicine
North Shields, Tyne and Wear, United Kingdom
Royal Sussex County Hospital, Neurology Department
Brighton, , United Kingdom
Countries
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Other Identifiers
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2939117
Identifier Type: -
Identifier Source: org_study_id
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