A Phase 4 interventional study of Stalevo in Parkinson's Disease, sponsored by Orion Corporation, Orion Pharma. Completed at 20 sites in 3 countries. Open to participants aged 35 Years and older. Per ClinicalTrials.gov, last updated 2015-04-21.
Sponsored by Orion Corporation, Orion Pharma · Phase 4, Interventional, and Treatment
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.
See 'Brief summary'.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's enrollment of 115 is above the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Orion Corporation, Orion Pharma is the lead sponsor of 100 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Stalevo
Drug: Stalevo
Oral 3-4 daily doses for 6 weeks
Clinical Global Impression of Change (Patient)
Time frame: 6 weeks
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
Time frame: 6 weeks
This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
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Orion Corporation, Orion Pharma