Status:
COMPLETED
Study to Evaluate Initiation of Stalevo in Early Wearing-off
Lead Sponsor:
Orion Corporation, Orion Pharma
Conditions:
Parkinson's Disease
Eligibility:
All Genders
35+ years
Phase:
PHASE4
Brief 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...
Detailed Description
See 'Brief summary'.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT00462007
Start Date
September 1 2006
End Date
December 1 2007
Last Update
April 21 2015
Active Locations (20)
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1
Humboldt Universität Charité Neurologische Klinik
Berlin, Germany, 10098
2
St. Josef-Hospital, Klinikum der Ruhr-Universität-Bochum Neurologische Klinik
Bochum, Germany, 44791
3
Pharmakologisches Studienzentrum Chemnitz
Chemnitz, Germany, 09111
4
Nervenarztpraxis Dr Alexander Nass
Cologne, Germany, 51069