We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00212693
First Posted: September 21, 2005
Last Update Posted: October 11, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd
  Purpose
The purpose of this study is to evaluate the efficacy and safety of ONO-2506PO in patients with Parkinson's Disease

Condition Intervention Phase
Parkinson's Disease Drug: ONO-2506PO Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Controlled Study of ONO-2506PO in Patients With Parkinson's Disease in Japan

Resource links provided by NLM:


Further study details as provided by Ono Pharmaceutical Co. Ltd:

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

Estimated Enrollment: 165
Study Start Date: January 2004
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00212693


Sponsors and Collaborators
Ono Pharmaceutical Co. Ltd
Investigators
Study Director: Project Leader, Development Planning Ono Pharmaceutical Co. Ltd
  More Information

Responsible Party: Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier: NCT00212693     History of Changes
Other Study ID Numbers: ONO-2506PO-03
First Submitted: September 13, 2005
First Posted: September 21, 2005
Last Update Posted: October 11, 2012
Last Verified: October 2012

Keywords provided by Ono Pharmaceutical Co. Ltd:
ONO-2506PO, Parkinson's disease

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases