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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier:
NCT00212693
First received: September 13, 2005
Last updated: October 10, 2012
Last verified: October 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Controlled Study of ONO-2506PO in Patients With Parkinson's Disease in Japan

Resource links provided by NLM:

U.S. FDA Resources

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

Ages Eligible for Study:   20 Years to 79 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00212693

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

No publications provided

Responsible Party: Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier: NCT00212693     History of Changes
Other Study ID Numbers: ONO-2506PO-03
Study First Received: September 13, 2005
Last Updated: October 10, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

ClinicalTrials.gov processed this record on May 23, 2013