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Controlled Study of ONO-2506PO in Patients With Parkinson's Disease in Japan
This study has been completed.
First Received: September 13, 2005   Last Updated: April 3, 2006   History of Changes
Sponsored by: Ono Pharma
Information provided by: Ono Pharma
ClinicalTrials.gov Identifier: NCT00212693
  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 II

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease
MedlinePlus related topics: Parkinson's Disease
Drug Information available for: Arundic acid
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title: Controlled Study of ONO-2506PO in Patients With Parkinson's Disease in Japan

Further study details as provided by Ono Pharma:

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
  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 Pharma
Investigators
Study Director: Project Leader, Development Planning Ono Pharma
  More Information

No publications provided

Study ID Numbers: ONO-2506PO-03
Study First Received: September 13, 2005
Last Updated: April 3, 2006
ClinicalTrials.gov Identifier: NCT00212693     History of Changes
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Ono Pharma:
ONO-2506PO, Parkinson's disease

Study placed in the following topic categories:
Ganglion Cysts
Movement Disorders
Parkinson Disease
Basal Ganglia Diseases
 Central Nervous System Diseases
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases

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

ClinicalTrials.gov processed this record on May 07, 2009



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