- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00957203
Long-Term Safety Study of KW-6002 (Istradefylline) in Parkinson's Disease Patients (6002-010)
August 30, 2012 updated by: Kyowa Kirin Co., Ltd.
Long-Term Safety Study of KW-6002 (Istradefylline) in the Treatment of Parkinson's Disease (Phase 3)
Patients with Parkinson's disease who completed the prior double-blind study 6002-009 are eligible to enter into this long-term study.
The purpose of this study is to evaluate the safety and efficacy of KW-6002 administered long-term in patients with advanced Parkinson's disease treated with levodopa.
Study Overview
Study Type
Interventional
Enrollment (Actual)
308
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tokyo, Japan
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Be willing and able to give written informed consent
- Completion of the study 6002-009
Exclusion Criteria:
- Mini-mental status examination score of 23 or less
- Less than 70% of compliance in the study 6002-009
- Emergency deviation in the study 6002-009
- Pregnant females
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Istradefylline
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Oral istradefylline (KW-6002) 20 or 40 mg once daily
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Adverse events
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Secondary Outcome Measures
Outcome Measure |
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Reducing the mean total hours of awake time per day spent in the OFF state
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Reducing the mean percentage of awake time per day spent in the OFF state
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Mean change in the total hours and the percentage of awake time per day spent in the ON state (without dyskinesia, with dyskinesia, with non-troublesome dyskinesia, and with troublesome dyskinesia)
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Change in Unified Parkinson's Disease Rating Scale (UPDRS)
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Change in the Clinical Global Impression - Improvement scale (CGI-I)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2009
Primary Completion (Actual)
September 1, 2011
Study Completion (Actual)
March 1, 2012
Study Registration Dates
First Submitted
August 7, 2009
First Submitted That Met QC Criteria
August 11, 2009
First Posted (Estimate)
August 12, 2009
Study Record Updates
Last Update Posted (Estimate)
August 31, 2012
Last Update Submitted That Met QC Criteria
August 30, 2012
Last Verified
August 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Parkinson Disease
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Purinergic Antagonists
- Purinergic Agents
- Purinergic P1 Receptor Antagonists
- Adenosine A2 Receptor Antagonists
- Istradefylline
Other Study ID Numbers
- 6002-010
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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