- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00199407
A Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease in Patients Taking Levodopa
April 23, 2024 updated by: Kyowa Kirin, Inc.
A 12-week, Double Blind, Placebo-controlled, Randomized, Parallel Group, Multicenter, Fixed Dose Study to Evaluate the Efficacy and Safety of a 20 mg/d Oral Dose of KW-6002 (Istradefylline) as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa/Carbidopa Therapy.
To establish the efficacy of a 20 mg/day dose of istradefylline for reducing the percentage of OFF time in patients with advanced Parkinson's disease (PD) treated with levodopa.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
To establish the efficacy of a 20 mg/d dose of istradefylline for reducing the percentage of OFF time in patients with advanced Parkinson's disease (PD) treated with levodopa.
Patients who meet entry criteria will be randomized in a 1 to 1 ratio to either istradefylline or matching placebo.
Patients will be treated for 12 weeks and will have interim visits and end of treatment visit to assess the efficacy and safety of istradefylline as compared to placebo.
Study Type
Interventional
Enrollment
230
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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New Jersey
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Princeton, New Jersey, United States, 08540
- Kyowa Pharmaceutical Inc.
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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
30 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- UK Parkinson's Disease Society (UKPDS) brain bank criteria (Step 1 and 2) for PD.
- PD stages 2-4 in the OFF state for Modified Hoehn and Yahr Scale.
- On levodopa/carbidopa for at least one year, stable dose in past 4 weeks.
- Currently take at least three doses of levodopa/carbidopa per day.
- Predictable end of dose wearing off.
- Able to satisfactorily complete Hauser version of a Parkinson's diary.
- Have an average of 180 minutes of OFF time on two 24 hour diaries.
- Be at least 30 years of age.
Exclusion Criteria:
- Neurosurgical treatment for PD.
- History of psychosis.
- Diagnosis of atypical parkinsonism, secondary parkinsonism variant or Parkinson's plus syndromes.
- Diagnosis of cancer within 5 years.
- Mini-mental status examination score of 25 or less.
- History of seizures or neurologic malignant_syndrome.
- Clinical depression.
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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To establish the efficacy of a 20 mg/d dose of istradefylline for reducing the percentage of OFF time in patients with advanced Parkinson's disease (PD) treated with levodopa/carbidopa.
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Secondary Outcome Measures
Outcome Measure |
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To evaluate change in the Clinical Global Impression - Severity of Illness scale (CGI-S).
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To evaluate the change in Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination score (part III) and/or in Activities of Daily Living (ADL) score (part II).
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To evaluate the change in Parkinson's Disease Questionnaire (PDQ-39) and Medical Outcomes Study 36-item Short Form (SF-36).
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To evaluate the change in percentage of ON time (without dyskinesia, with dyskinesia, with non-troublesome dyskinesia, and with troublesome dyskinesia).
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To evaluate the efficacy of a 20 mg/d dose of istradefylline for reducing the total hours of OFF time.
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To evaluate the change in the Patient Global Impression - Improvement scale (PGI-I).
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To evaluate the safety of a 20 mg/d dose of istradefylline.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Neil Sussman, MD, Kyowa Kirin, Inc.
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
June 1, 2004
Primary Completion (Actual)
November 1, 2005
Study Completion (Actual)
January 1, 2006
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimated)
September 20, 2005
Study Record Updates
Last Update Posted (Actual)
April 25, 2024
Last Update Submitted That Met QC Criteria
April 23, 2024
Last Verified
April 1, 2024
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-US-013
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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