A Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease
A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/Day KW-6002 (Istradefylline) and That of Entacapone Versus Placebo as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa Therapy.
1 other identifier
interventional
405
1 country
1
Brief Summary
The purpose of this study is to evaluate the efficacy of 40 mg a day of istradefylline (KW-6002) for reducing the percentage of awake time spent in the OFF state in patients with advanced Parkinson's disease treated with levodopa.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2004
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 20, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2005
CompletedApril 25, 2024
April 1, 2024
11 months
September 12, 2005
April 23, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
OFF time assessed by patient diaries at endpoint.
Secondary Outcomes (8)
Efficacy: OFF time
ON time
UPDRS (parts I-IVa)
PDQ-39, PCG-I, CGI-S and SF-36 scores at endpoint.
Safety: clinical laboratory tests
- +3 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- Patients selected for this study will be at least 30 years of age and will have been diagnosed with advanced Parkinson's disease as determined by UK Parkinson's Disease Society (UKPDS) criteria and the Modified Hoehn and Yahr Scale. The patients will have been receiving levodopa treatment for at least one year, may be taking other antiparkinsonian drugs, will have an average of at least three hours OFF time as recorded in two 24-hour ON/OFF diaries, and if female, must be non-pregnant and non-nursing.
You may not qualify if:
- Patients may not be enrolled if they are taking certain medications excluded by the protocol, have been treated with any investigational drug within 30 days prior to randomisation (or five half-lives if longer), have ever received istradefylline or been treated with a COMT inhibitor, are psychotic, have clinically significant illness or laboratory values at screening, have insufficient mental capacity to comply with protocol requirements or certain psychiatric or neurological conditions.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kyowa Kirin Co., Ltd.lead
- Kyowa Hakko Kirin UK, Ltd.collaborator
Study Sites (1)
Kyowa Hakko UK Ltd.
Slough, Berkshire, SL14 DX, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 20, 2005
Study Start
November 1, 2004
Primary Completion
October 1, 2005
Study Completion
November 1, 2005
Last Updated
April 25, 2024
Record last verified: 2024-04