A 12-week Randomized Study to Evaluate Oral Istradefylline in Subjects With Moderate to Severe Parkinson's Disease

Status:	Active, not recruiting
Conditions:	Parkinsons Disease
Therapuetic Areas:	Neurology
Healthy:	No
Age Range:	30 - Any
Updated:	7/14/2016
Start Date:	October 2013
End Date:	November 2016

A Phase 3, 12-week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study to Evaluate the Efficacy of Oral Istradefylline 20 and 40 mg/Day as Treatment for Subjects With Moderate to Severe Parkinson's Disease

This is a study to assess the efficacy and safety of oral Istradefylline (KW-6002) in
patients with moderate to severe Parkinson's Disease. While on this study, participants will
continue to take their usual, prescribed, stable regimen of Levodopa/Carbidopa or
Levodopa/Benserazide therapy plus adjunct Parkinson's medications. Patients will be
randomized 1:1:1 to receive either Istradefylline 20 mg per day, or Istradefylline 40 mg per
day or an equivalent placebo. Patients will be treated for a 12 week period to demonstrate
the effectiveness of Istradefylline in improving Parkinson's disease symptoms (referred to
as improvement in patient OFF time) and that Istradefylline has an acceptable safety profile
in this group.

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

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A 12-week Randomized Study to Evaluate Oral Istradefylline in Subjects With Moderate to Severe Parkinson's Disease

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A Phase 3, 12-week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study to Evaluate the Efficacy of Oral Istradefylline 20 and 40 mg/Day as Treatment for Subjects With Moderate to Severe Parkinson's Disease

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