Status:
COMPLETED
A Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease
Lead Sponsor:
Kyowa Kirin Co., Ltd.
Conditions:
Parkinson's Disease
Eligibility:
All Genders
30+ years
Phase:
PHASE2
Brief Summary
To establish the efficacy of 40 mg/day doses of istradefylline for the change in Unified Parkinson's Disease Rating Scale (UPDRS) part-III (Motor examination) score in patients with Parkinson's diseas...
Detailed Description
To establish the efficacy of 40mg/d doses of istradefylline for the change in UPDRS part-III (Motor examination) score in patients with Parkinson's disease (PD). Patients who meet entry criteria will ...
Eligibility Criteria
Inclusion
- UK Parkinson's Disease Society (UKPDS) brain bank criteria (Step 1 and 2) for PD.
- PD stages 1-3 for Modified Hoehn and Yahr Scale.
- Be at least 30 years of age.
Exclusion
- Neurosurgical treatment for PD.
- History of psychosis.
- Diagnosis of cancer within 5 years.
- Diagnosis of clinically significant illness of any organ system.
- Mini-mental status examination score of 25 or less.
- Taking any excluded medications.
- History of drug or alcohol abuse or dependence within the past two years.
- History of seizures or neurological malignant syndrome.
- Clinical depression.
- Pregnant or lactating females.
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
End Date :
October 1 2006
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00250393
Start Date
November 1 2005
End Date
October 1 2006
Last Update
August 29 2012
Active Locations (1)
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1
Tokyo, Japan