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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | April 17, 2007 | ||||
| Last Updated Date | February 5, 2008 | ||||
| Start Date ICMJE | September 2006 | ||||
| Primary Completion Date | August 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Clinical Global Impression of Change (Patient) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Clinical Global Impression of Change (Patient) | ||||
| Change History | Complete list of historical versions of study NCT00462007 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
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 | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Study to Evaluate Initiation of Stalevo in Early Wearing-Off | ||||
| Official Title ICMJE | 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 | ||||
| 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 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. |
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| Detailed Description | See 'Brief summary'. |
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| Study Phase | Phase IV | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Parkinson's Disease | ||||
| Intervention ICMJE | Drug: Stalevo | ||||
| Study Arms / Comparison Groups | Experimental: Stalevo | ||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 115 | ||||
| Completion Date | December 2007 | ||||
| Primary Completion Date | August 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 35 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Germany, Sweden, United Kingdom | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00462007 | ||||
| Responsible Party | Liisa Luotonen, Orion Pharma | ||||
| Study ID Numbers ICMJE | 2939117 | ||||
| Study Sponsor ICMJE | Orion Corporation, Orion Pharma | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Orion Corporation, Orion Pharma | ||||
| Verification Date | February 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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