- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00199433
A Study of Istradefylline (KW-6002) as Monotherapy in Parkinson's Disease (PD) Patients
A Phase 2, Double-blind, Placebo-controlled, Randomized, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of 40mg/Day KW-6002 (Istradefylline) as Monotherapy in Subjects With Parkinson's Disease
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Parkinson's disease is a progressive disease which results in deterioration of motor function and is the result of dopamine depletion in specific brain structures. Current therapeutic approaches include dopamine replacement and the use of dopamine receptor agonist drugs. These therapies are effective but may be associated with unwanted complications like wearing off phenomena and involuntary abnormal movements (dyskinesia). Istradefylline may provide a nondopaminergic approach to the treatment of Parkinson's disease.
This study will compare the efficacy of 40 mg per day of istradefylline in improving the symptoms of Parkinson's disease with placebo.
Study Type
Enrollment
Phase
- Phase 2
Contacts and Locations
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
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Early PD by UKPDS criteria
- Mild to moderate difficulty daily activities
- Females: Either postmenopausal or willing to use adequate contraception
Exclusion Criteria:
- Unable to discontinue current PD medication
- Exposure to Levodopa for more than 1 month
- Symptoms that may suggest a diagnosis other than Parkinson's disease
- Medical conditions and/or abnormal laboratory findings which preclude participation including cancer in the last 5 years, a history of drug abuse/dependence, abnormal cognitive status, a history of seizures, neuroleptic malignant syndrome, psychosis, or abnormal liver function tests
Study Plan
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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Change from baseline in the UPDRS subscale III at endpoint.
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Secondary Outcome Measures
Outcome Measure |
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weight
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Safety:
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ECG
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Interim actual and change from baseline values in UPDRS total and subscale scores, Clinical Global Impression, measures of motor performance, and neuropsychological testing.
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Exam
|
vitals
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laboratory tests and adverse events
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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
- Synucleinopathies
- Neurodegenerative Diseases
- Parkinson Disease
- Movement Disorders
- 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-051
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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Clinical Trials on Istradefylline (KW-6002)
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Kyowa Hakko Kirin UK, Ltd.CompletedParkinson's DiseaseUnited Kingdom
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Kyowa Hakko Kirin Pharma, Inc.Kyowa Kirin Co., Ltd.CompletedIdiopathic Parkinson's DiseaseUnited States, Canada, Czechia, Germany, Israel, Italy, Poland, Serbia
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Kyowa Kirin, Inc.CompletedSleep Disorder | Restless Legs SyndromeUnited States
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Kyowa Kirin Co., Ltd.CompletedParkinson's DiseaseJapan
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Kyowa Kirin Co., Ltd.CompletedParkinson's DiseaseJapan
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Kyowa Kirin, Inc.Kyowa Hakko Kirin UK, Ltd.CompletedParkinson's DiseaseUnited States
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Kyowa Kirin, Inc.CompletedParkinson's DiseaseUnited States
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Kyowa Kirin, Inc.CompletedParkinson's DiseaseUnited States
-
Kyowa Kirin, Inc.Completed