NCT00212693

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
165

participants targeted

Target at P75+ for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2005

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
Last Updated

October 11, 2012

Status Verified

October 1, 2012

Enrollment Period

1.7 years

First QC Date

September 13, 2005

Last Update Submit

October 10, 2012

Conditions

Parkinson's Disease

Keywords

ONO-2506PO, Parkinson's disease

Outcome Measures

Primary Outcomes (1)

  • Unified Parkinson's disease rating scale (Part III)

Secondary Outcomes (1)

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

Interventions

ONO-2506PODRUG

Eligibility Criteria

Age20 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Previous participation in ONO-2506PO or ONO-2506 protocol
  • Previous brain surgery for Parkinson's disease
  • Presence or history of serious cardiac disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Project Leader, Development Planning

    Ono Pharmaceutical Co. Ltd

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

January 1, 2004

Primary Completion

September 1, 2005

Last Updated

October 11, 2012

Record last verified: 2012-10