Controlled Study of ONO-2506PO in Patients With Parkinson's Disease in Japan
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
ONO-2506PO
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring ONO-2506PO, Parkinson's disease
Eligibility Criteria
Inclusion Criteria: Diagnosis of Parkinson's disease Stage 2 - Stage 4 of revised Hoehn & Yahr severity score Taking L-dopa/DCI without changing dose and regimen Having motor complication Other inclusion criteria as specified in the study protocol Exclusion Criteria: Previous participation in ONO-2506PO or ONO-2506 protocol Previous brain surgery for Parkinson's disease Presence or history of serious cardiac disease Other exclusion criteria as specified in the study protocol
Sites / Locations
Outcomes
Primary Outcome Measures
Unified Parkinson's disease rating scale (Part III)
Secondary Outcome Measures
Unified Parkinson's disease rating scale (Part I, II, IV and total), revised Hoehn & Yahr severity score and off time
Full Information
NCT ID
NCT00212693
First Posted
September 13, 2005
Last Updated
October 10, 2012
Sponsor
Ono Pharmaceutical Co. Ltd
1. Study Identification
Unique Protocol Identification Number
NCT00212693
Brief Title
Controlled Study of ONO-2506PO in Patients With Parkinson's Disease in Japan
Official Title
Controlled Study of ONO-2506PO in Patients With Parkinson's Disease in Japan
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
September 2005 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ono Pharmaceutical Co. Ltd
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of ONO-2506PO in patients with Parkinson's Disease
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
ONO-2506PO, Parkinson's disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
165 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
ONO-2506PO
Primary Outcome Measure Information:
Title
Unified Parkinson's disease rating scale (Part III)
Secondary Outcome Measure Information:
Title
Unified Parkinson's disease rating scale (Part I, II, IV and total), revised Hoehn & Yahr severity score and off time
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of Parkinson's disease
Stage 2 - Stage 4 of revised Hoehn & Yahr severity score
Taking L-dopa/DCI without changing dose and regimen
Having motor complication
Other inclusion criteria as specified in the study protocol
Exclusion Criteria:
Previous participation in ONO-2506PO or ONO-2506 protocol
Previous brain surgery for Parkinson's disease
Presence or history of serious cardiac disease
Other exclusion criteria as specified in the study protocol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Project Leader, Development Planning
Organizational Affiliation
Ono Pharmaceutical Co. Ltd
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Controlled Study of ONO-2506PO in Patients With Parkinson's Disease in Japan
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