Stalevo in Early Wearing-Off Patients
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: Idiopathic Parkinson's Disease
Intervention: Stalevo (levodopa/carbidopa/entacapone) (Drug); Levodopa/carbidopa (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Orion Corporation, Orion Pharma Official(s) and/or principal investigator(s):
Andrew Wighton, BSc (Hons), Study Director, Affiliation: Orion Corporation, Orion Pharma
Bhadravati SD Sastry, FRCP, Principal Investigator, Affiliation: University Hospital of Wales and Rookwood Hospital
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.
Clinical Details
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 design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Primary outcome: The time until a patient requires changes in antiparkinsonian therapy due to inadequately controlled parkinsonian symptoms
Secondary outcome: Unified Parkinson's Disease Rating ScaleClinical Global Impression of Change (investigator) Parkinson's Disease Questionnaire (PDQ-39) Work Impairment Questionnaire
Eligibility
Minimum age: 30 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Århus Kommunehospital, Nørrebrogade 44 8000, Denmark
Aalborg Hospital, Aalborg DK-9000 Aalborg, Denmark
Bispebjerg Hospital, Copenhagen, Denmark
South Karelia Central Hospital, Lappeenranta, Finland
Tampere University Hospital, Tampere 33521 Tampere, Finland
Allgemeines Krankenhaus Harburg, Hamburg 21075 Hamburg, Germany
Neurologische Klinik Bad Neustadt, Bad Neustadt 97616 Bad Neustadt, Germany
Parkinson Klinik Bad Nauheim, Bad Nauheim 61231 Bad Nauheim, Germany
Praxis Drs Lang, Krauss, Schreiber, Ulm 89073 Ulm, Germany
Neurologische Klinik der Universitat Dusseldorf, Duesseldorf 40225 Duesseldorf, Germany
Mater Private Hospital, Dublin Dublin 7, Ireland
Läkarhuset Vällingby, Vällingby SE-162 68, Sweden
Universitetssjukhuset MAS, Malmö SE-205 02, Sweden
Frenchay Hospital, Bristol BS16 1LE, United Kingdom
Southampton General Hospital, Southampton SO16 6YD, United Kingdom
Leigh Infirmary, Leigh WN7 1HS, United Kingdom
Movement Disorder Services, Chertsey, Surrey KT16 0QA, United Kingdom
University Hospital of Wales, Cardiff, Wales CF14 4XW, United Kingdom
Glan Clwyd Hospital, Rhyl, Wales CF14 4XW, United Kingdom
Additional Information
Starting date: August 2005
Ending date: July 2009
Last updated: January 17, 2008
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