A 12-week Randomized Study to Evaluate Oral Istradefylline in Subjects With Moderate to Severe Parkinson's Disease
Launched by KYOWA KIRIN CO., LTD. · Oct 18, 2013
Trial Information
Current as of August 11, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 30 years of age or older.
- • 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:
- • Subjects on apomorphine and/or dopamine receptor antagonists or direct gastrointestinal levodopa infusion.
- • Subject who have had neurosurgical operation for PD
- • Subjects taking A2a antagonist, potent CYP3A4 inhibitors, potent CYP34A inducers
- • Subjects who smoke \> 5 cigarettes/day
About Kyowa Kirin Co., Ltd.
Kyowa Kirin Co., Ltd. is a global pharmaceutical company headquartered in Japan, dedicated to the discovery, development, and commercialization of innovative therapies to address unmet medical needs. With a strong emphasis on biotechnology, the company focuses on areas such as oncology, nephrology, and immunology, leveraging advanced research and development capabilities to enhance patient outcomes. Kyowa Kirin is committed to ethical practices and collaboration in clinical trials, ensuring the highest standards of safety and efficacy in its therapeutic offerings. Through its dedication to scientific excellence and patient-centric approaches, Kyowa Kirin strives to improve the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Phoenix, Arizona, United States
Sun City, Arizona, United States
Tucson, Arizona, United States
Fountain Valley, California, United States
Irvine, California, United States
Los Angeles, California, United States
Oxnard, California, United States
Pasadena, California, United States
Reseda, California, United States
Sunnyvale, California, United States
Torrance, California, United States
Englewood, Colorado, United States
Danbury, Connecticut, United States
Boca Raton, Florida, United States
Jacksonville, Florida, United States
Panama City, Florida, United States
Port Charlotte, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Augusta, Georgia, United States
Chicago, Illinois, United States
Des Moines, Iowa, United States
Kansas City, Kansas, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
West Bloomfield, Michigan, United States
Minneapolis, Minnesota, United States
Saint Louis, Missouri, United States
Albany, New York, United States
New York, New York, United States
Asheville, North Carolina, United States
Durham, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Toledo, Ohio, United States
Philadelphia, Pennsylvania, United States
Charleston, South Carolina, United States
Dallas, Texas, United States
Houston, Texas, United States
Calgary, Alberta, Canada
Kingston, Ontario, Canada
Toronto, Ontario, Canada
Gatineau, Quebec, Canada
Quebec City, Quebec, Canada
Brno, , Czechia
Litomysl, , Czechia
Olomouc, , Czechia
Prague, , Czechia
Beelitz Heilstätten, , Germany
Berlin, , Germany
Bremerhaven, , Germany
Dresden, , Germany
Gottingen, , Germany
Haag, , Germany
Kassel, , Germany
Marburg, , Germany
Munich, , Germany
Tubingen, , Germany
Ulm, , Germany
Haifa, , Israel
Jerusalem, , Israel
Petach Tiqva, , Israel
Ramat Gan, , Israel
Tel Aviv, , Israel
Cassino, , Italy
Chieti, , Italy
Grosseto, , Italy
Pavia, , Italy
Pisa, , Italy
Rome, , Italy
Venezia, , Italy
Vicenza, , Italy
Bydgoszcz, , Poland
Kielce, , Poland
Krakow, , Poland
Lublin, , Poland
Poznan, , Poland
Warsaw, , Poland
Belgrade, , Serbia
Belgrade, , Serbia
Belgrade, , Serbia
Novi Sad, , Serbia
Patients applied
Trial Officials
Kyowa Hakko Kirin Pharma, Inc.
Study Chair
Kyowa Hakko Kirin Pharma, Inc.
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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