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NCT00212693 Clinical Trial

Controlled Study of ONO-2506PO in Patients With Parkinson's Disease in Japan

Parkinson's Disease Clinical Trial

Official title:
Controlled Study of ONO-2506PO in Patients With Parkinson's Disease in Japan

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00212693
Other study ID # ONO-2506PO-03
Secondary ID
Status Completed
Phase Phase 2
First received September 13, 2005
Last updated October 10, 2012
Start date January 2004

Study information
Verified date October 2012
Source Ono Pharmaceutical Co. Ltd
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of ONO-2506PO in patients with Parkinson's Disease

Recruitment information / eligibility
Status Completed
Enrollment 165
Est. completion date
Est. primary completion date September 2005
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 79 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• ONO-2506PO

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Ono Pharmaceutical Co. Ltd

Outcome
Type Measure Description Time frame Safety issue
Primary Unified Parkinson's disease rating scale (Part III)
Secondary Unified Parkinson's disease rating scale (Part I, II, IV and total), revised Hoehn & Yahr severity score and off time
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