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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00212693 |
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Date of registration:
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13/09/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Controlled Study of ONO-2506PO in Patients With Parkinson's Disease in Japan
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Scientific title:
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Controlled Study of ONO-2506PO in Patients With Parkinson's Disease in Japan |
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Date of first enrolment:
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January 2004 |
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Target sample size:
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165 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00212693 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Phase:
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Phase 2
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Contacts
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Name:
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Project Leader, Development Planning |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ono Pharmaceutical Co. Ltd |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Diagnosis of Parkinson's disease
2. Stage 2 - Stage 4 of revised Hoehn & Yahr severity score
3. Taking L-dopa/DCI without changing dose and regimen
4. Having motor complication
5. Other inclusion criteria as specified in the study protocol
Exclusion Criteria:
1. Previous participation in ONO-2506PO or ONO-2506 protocol
2. Previous brain surgery for Parkinson's disease
3. Presence or history of serious cardiac disease
4. Other exclusion criteria as specified in the study protocol
Age minimum:
20 Years
Age maximum:
79 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Parkinson's Disease
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Intervention(s)
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Drug: ONO-2506PO
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Primary Outcome(s)
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Unified Parkinson's disease rating scale (Part III)
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Secondary Outcome(s)
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Unified Parkinson's disease rating scale (Part I, II, IV and total), revised Hoehn & Yahr severity score and off time
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Secondary ID(s)
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ONO-2506PO-03
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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