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

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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

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
We found this trial at
42
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Phoenix, Arizona 85004
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Albany, New York 12208
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Asheville, North Carolina 28806
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Atlanta, Georgia 30329
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Augusta, Georgia 29841
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Baltimore, Maryland 21201
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Boca Raton, Florida 33486
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Boston, Massachusetts 02215
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Calgary, Alberta
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Calgary,
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Charleston, South Carolina 29401
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Chicago, Illinois 60611
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Chicago, Illinois 60611
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Cincinnati, Ohio 45267
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Cleveland, Ohio 44195
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Dallas, Texas 75390
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Danbury, Connecticut 06810
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Des Moines, Iowa 50309
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Durham, North Carolina 27705
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Englewood, Colorado 80113
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Fountain Valley, California 92708
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Houston, Texas 77030
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Irvine, California 92697
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Jacksonville, Florida 32209
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Kansas City, Kansas 66160
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Los Angeles, California 90048
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Minneapolis, Minnesota 55414
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New York, New York 10032
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New York, New York 10032
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Oxnard, California 93030
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Panama City, Florida 32405
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Pasadena, California 91104
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Philadelphia, Pennsylvania 19107
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Port Charlotte, Florida 33980
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Reseda, California 91335
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St. Louis, Missouri 63110
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Sun City, Arizona 85351
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Sunnyvale, California 94085
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Tampa, Florida 33647
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Toledo, Ohio 43614
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Torrance, California 90505
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Tucson, Arizona 85724
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West Bloomfield, Michigan 48322
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