A 12-week Randomized Study to Evaluate Oral Istradefylline in Subjects With Moderate to Severe Parkinson's Disease (KW-6002)
Idiopathic Parkinson's Disease
About this trial
This is an interventional treatment trial for Idiopathic Parkinson's Disease focused on measuring Parkinson's disease, Moderate to Severe Parkinson's Disease
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
Sites / Locations
- Kyowa PD Site
- Kyowa PD Site
- Kyowa PD Site
- Kyowa PD Site
- Kyowa PD Site
- Kyowa PD Site
- Kyowa PD Site
- Kyowa PD Site
- Kyowa PD Site
- Kyowa PD Site
- Kyowa PD Site
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- Kyowa PD Site
- Kyowa PD Site
- Kyowa PD Site
- Kyowa PD Site
- Kyowa PD Site
- Kyowa PD Site
- Kyowa PD Site
- Kyowa PD Site
- Kyowa PD Site
- Kyowa PD Site
- Kyowa PD Site
- Kyowa PD Site
- Kyowa PD Site
- Kyowa PD Site
- Kyowa PD Site
- Kyowa PD Site
- Kyowa PD Site
- Kyowa PD Site
- Kyowa PD Site
- Kyowa PD Site
- Kyowa PD Site
- Kyowa PD Site
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- Kyowa PD Site
- Kyowa PD Site
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- Kyowa PD Site
- Kyowa PD Site
- Kyowa PD Site
- Kyowa PD Site
- Kyowa PD Site
- Kyowa PD Site
- Kyowa PD Site
- Kyowa PD Site
- Kyowa PD Site
- Kyowa PD Site
- Kyowa PD Site
- Kyowa PD Site
- Kyowa PD Site
- Kyowa PD Site
- Kyowa PD Site
- Kyowa PD Site
- Kyowa PD Site
- Kyowa PD Site
- Kyowa PD Site
- Kyowa PD Site
- Kyowa PD Site
- Kyowa PD Site
- Kyowa PD Site
- Kyowa PD Site
- Kyowa PD Site
- Kyowa PD Site
- Kyowa PD Site
- Kyowa PD Site
- Kyowa PD Site
- Kyowa PD Site
- Kyowa PD Site
- Kyowa PD Site
- Kyowa PD Site
- Kyowa PD Site
- Kyowa PD Site
- Kyowa PD Site
- Kyowa PD Site
- Kyowa PD Site
- Kyowa PD Site
- Kyowa PD Site
- Kyowa PD Site
- Kyowa PD Site
- Kyowa PD Site
- Kyowa PD Site
- Kyowa PD Site
- Kyowa PD Site 1
- Kyowa PD Site 2
- Kyowa PD Site 4
- Kyowa PD Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
Istradefylline 20 mg/day
Istradefylline 40 mg/day
Placebo
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 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.
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.