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

Phase 2

Completed

• Conditions: Parkinson's Disease

• Registration Number: NCT00212693
• Lead Sponsor: Ono Pharmaceutical Co. Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-01
• Primary Completion: 2005-09
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-20
• Study First Posted: 2005-09-21
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-10
• Last Update Posted: 2012-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 165

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Unified Parkinson's disease rating scale (Part III)

Secondary Outcome Measures

Name	Time	Method
Unified Parkinson's disease rating scale (Part I, II, IV and total), revised Hoehn & Yahr severity score and off time