A 12-week Randomized Study to Evaluate Oral Istradefylline in Subjects With Moderate to Severe Parkinson's Disease
NCT ID: NCT01968031
Last Updated: 2024-04-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
613 participants
INTERVENTIONAL
2013-10-31
2016-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Istradefylline 20 mg/day
Istradefylline 20 mg and placebo to match istradefylline 40 mg:
A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.
Istradefylline 20 mg
Istradefylline 20 mg and placebo
Placebo
Placebo
Istradefylline 40 mg/day
Istradefylline 40 mg and placebo to match istradefylline 20 mg:
A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.
Istradefylline 40 mg
Istradefylline 40 mg and placebo
Placebo
Placebo
Placebo
Placebo to match istradefylline 20 mg and placebo to match istradefylline 40 mg:
A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.
Placebo
Placebo
Interventions
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Istradefylline 40 mg
Istradefylline 40 mg and placebo
Istradefylline 20 mg
Istradefylline 20 mg and placebo
Placebo
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* UK Parkinson's Disease Society (UKPDS) brain bank criteria (Step 1 and 2) for PD
* PD Stages 2-4 in the ON state for Modified Hoehn and Yahr Scale.
* On levodopa therapy for at least 1 year with beneficial clinical response at the baseline visit
* Taking at least 400mg levodopa combination daily and on stable regimen of any other anti-Parkinsonian drugs (MAO-B, COMT, DA) for at least 2 weeks prior to randomization
* Stable dopaminergic regimen for at least 4 weeks immediately prior to randomization
* Documented end-of-dose wearing-off and levodopa-induced dyskinesia
* Have an average of two hours of OFF time per day
Exclusion Criteria
* Subject who have had neurosurgical operation for PD
* Subjects taking A2a antagonist, potent CYP3A4 inhibitors, potent CYP34A inducers
* Subjects who smoke \> 5 cigarettes/day
30 Years
ALL
No
Sponsors
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Kyowa Hakko Kirin Pharma, Inc.
INDUSTRY
Kyowa Kirin Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Kyowa Hakko Kirin Pharma, Inc.
Role: STUDY_CHAIR
Kyowa Hakko Kirin Pharma, Inc.
Locations
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Kyowa PD Site
Phoenix, Arizona, United States
Kyowa PD Site
Sun City, Arizona, United States
Kyowa PD Site
Tucson, Arizona, United States
Kyowa PD Site
Fountain Valley, California, United States
Kyowa PD Site
Irvine, California, United States
Kyowa PD Site
Los Angeles, California, United States
Kyowa PD Site
Oxnard, California, United States
Kyowa PD Site
Pasadena, California, United States
Kyowa PD Site
Reseda, California, United States
Kyowa PD Site
Sunnyvale, California, United States
Kyowa PD Site
Torrance, California, United States
Kyowa PD Site
Englewood, Colorado, United States
Kyowa PD Site
Danbury, Connecticut, United States
Kyowa PD Site
Boca Raton, Florida, United States
Kyowa PD Site
Jacksonville, Florida, United States
Kyowa PD Site
Panama City, Florida, United States
Kyowa PD Site
Port Charlotte, Florida, United States
Kyowa PD Site
Tampa, Florida, United States
Kyowa PD Site
Atlanta, Georgia, United States
Kyowa PD Site
Augusta, Georgia, United States
Kyowa PD Site
Chicago, Illinois, United States
Kyowa PD Site
Chicago, Illinois, United States
Kyowa PD Site
Des Moines, Iowa, United States
Kyowa PD Site
Kansas City, Kansas, United States
Kyowa PD Site
Baltimore, Maryland, United States
Kyowa PD Site
Boston, Massachusetts, United States
Kyowa PD Site
West Bloomfield, Michigan, United States
Kyowa PD Site
Minneapolis, Minnesota, United States
Kyowa PD Site
St Louis, Missouri, United States
Kyowa PD Site
Albany, New York, United States
Kyowa PD Site
New York, New York, United States
Kyowa PD Site
New York, New York, United States
Kyowa PD Site
Asheville, North Carolina, United States
Kyowa PD Site
Durham, North Carolina, United States
Kyowa PD Site
Cincinnati, Ohio, United States
Kyowa PD Site
Cleveland, Ohio, United States
Kyowa PD Site
Toledo, Ohio, United States
Kyowa PD Site
Philadelphia, Pennsylvania, United States
Kyowa PD Site
Charleston, South Carolina, United States
Kyowa PD Site
Dallas, Texas, United States
Kyowa PD Site
Houston, Texas, United States
Kyowa PD Site
Calgary, Alberta, Canada
Kyowa PD Site
Kingston, Ontario, Canada
Kyowa PD Site
Toronto, Ontario, Canada
Kyowa PD Site
Gatineau, Quebec, Canada
Kyowa PD Site
Québec, Quebec, Canada
Kyowa PD Site
Brno, , Czechia
Kyowa PD Site
Litomyšl, , Czechia
Kyowa PD Site
Olomouc, , Czechia
Kyowa PD Site
Prague, , Czechia
Kyowa PD Site
Prague, , Czechia
Kyowa PD Site
Prague, , Czechia
Kyowa PD Site
Beelitz-Heilstätten, , Germany
Kyowa PD Site
Berlin, , Germany
Kyowa PD Site
Berlin, , Germany
Kyowa PD Site
Bremerhaven, , Germany
Kyowa PD Site
Dresden, , Germany
Kyowa PD Site
Göttingen, , Germany
Kyowa PD Site
Haag, , Germany
Kyowa PD Site
Kassel, , Germany
Kyowa PD Site
Marburg, , Germany
Kyowa PD Site
Munich, , Germany
Kyowa PD Site
Tübingen, , Germany
Kyowa PD Site
Ulm, , Germany
Kyowa PD Site
Haifa, , Israel
Kyowa PD Site
Jerusalem, , Israel
Kyowa PD Site
Petach Tiqva, , Israel
Kyowa PD Site
Ramat Gan, , Israel
Kyowa PD Site
Tel Aviv, , Israel
Kyowa PD Site
Cassino, , Italy
Kyowa PD Site
Chieti, , Italy
Kyowa PD Site
Grosseto, , Italy
Kyowa PD Site
Pavia, , Italy
Kyowa PD Site
Pisa, , Italy
Kyowa PD Site
Rome, , Italy
Kyowa PD Site
Rome, , Italy
Kyowa PD Site
Venezia, , Italy
Kyowa PD Site
Vicenza, , Italy
Kyowa PD Site
Bydgoszcz, , Poland
Kyowa PD Site
Kielce, , Poland
Kyowa PD Site
Krakow, , Poland
Kyowa PD Site
Lublin, , Poland
Kyowa PD Site
Poznan, , Poland
Kyowa PD Site
Warsaw, , Poland
Kyowa PD Site
Warsaw, , Poland
Kyowa PD Site 1
Belgrade, , Serbia
Kyowa PD Site 2
Belgrade, , Serbia
Kyowa PD Site 4
Belgrade, , Serbia
Kyowa PD Site
Novi Sad, , Serbia
Countries
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Related Links
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Other Identifiers
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2013-002254-70
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
6002-014
Identifier Type: -
Identifier Source: org_study_id
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