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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

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring ONO-2506PO, Parkinson's disease

Eligibility Criteria

20 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Eligibility Criteria

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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