Study to Evaluate Initiation of Stalevo in Early Wearing-Off
Information source: Orion Corporation, Orion Pharma
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Parkinson's Disease
Intervention: Stalevo (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Orion Corporation, Orion Pharma Official(s) and/or principal investigator(s):
Wolfgang H. Oertel, Professor, Principal Investigator, Affiliation: Universitätsklinikum Giessen und Marburg GmbH
Summary
An open, non-randomised, multinational, multicentre direct switch study in levodopa-treated
Parkinson's disease patients suffering from early wearing-off in Parkinson's disease. The
study will consist of 2 consecutive periods: screening period and study treatment period.
Duration of the study will be up to 8 weeks for each subject. The study treatment dosage will
be determined by the subject's current, separately administered standard levodopa/DDCI
treatment (3-4 doses per day, maximum of total daily dose of 600 mg levodopa) which will be
switched to an equivalent dose of Stalevo® without changing the number of doses per day. The
levodopa daily dose during Stalevo® treatment may be adjusted according to the study
subject's clinical response.
Clinical Details
Official title: Efficacy and Safety of Stalevo® in Subjects With Early Wearing-Off Identified Using a Screening Tool WOQ-9; an Open, Non-Randomised, Multinational, Multicentre 6-Week Direct Switch Study in Levodopa-Treated Parkinson's Disease Patients
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Clinical Global Impression of Change (Patient)
Secondary outcome: Clinical Global Impression of Change (Investigator); United Parkinson's Disease Rating Scale (II, III); Quality of Life Visual Analogue Scale; Wearing-off Questionnaire with 9 symptoms
Detailed description:
See 'Brief summary'.
Eligibility
Minimum age: 35 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Subjects with idiopathic Parkinson's disease and early wearing-off symptoms treated
with standard levodopa/DDCI treatment
- 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:
- Atypical or symptomatic Parkinson's disease
- 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.
Locations and Contacts
Universitätsklinikum Gießen und Marburg GmbH, Marburg D-35039, Germany
Universitätsklinikum Carl Gustav Carus Klinik und Poliklinik für Neurologie, Dresden 01307, Germany
Eberhard-Karls-Universität, Universitätsklinikum Tübingen, Zentrum für Neurologie, Tübingen 72076, Germany
Humboldt Universität Charité Neurologische Klinik, Berlin 10098, Germany
St. Josef-Hospital, Klinikum der Ruhr-Universität-Bochum Neurologische Klinik, Bochum 44791, Germany
Alexianer-Krankenhaus, Krefeld 47805, Germany
Nervenarztpraxis Dr Alexander Nass, Köln 51069, Germany
Neurologische Praxis Dr Christine Schuster, Giessen 35390, Germany
Gemeinschaftspraxis für Neurologie & Psychiatrie, Erbach 64711, Germany
Neurologische Klinik der Universität Ulm, Ulm 89081, Germany
Pharmakologisches Studienzentrum Chemnitz, Chemnitz 09111, Germany
Asklepios Fachklinikum Stadtroda, Stadtroda 07646, Germany
Paracelsus-Elena Klinik, Kassel 34128, Germany
Universitätskrankenhaus Eppendorf, Hamburg 20251, Germany
Nyköpings Lasarett, Ger/Rehabkliniken, Nyköping 61185, Sweden
Visby lasarett, Neurologmottagningen, Visby 62184, Sweden
Länsjukhuset Ryhov, Geriatriska Kliniken, Jönköping 55185, Sweden
Royal Sussex County Hospital, Neurology Department, Brighton BN2 5BE, United Kingdom
The Royal Bournemouth Hospital, Department of Medicines for the Elderly, Bournemouth, Dorset BH7 7DW, United Kingdom
North Tyneside General Hospital, Department of Medicine, North Shields, Tyne and Wear NE29 8NH, United Kingdom
Additional Information
Starting date: September 2006
Ending date: December 2007
Last updated: February 5, 2008
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