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

Use our guide to learn which trials are right for you!

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
sites
Chicago, Illinois 60611
274
mi
from 43215
Chicago, IL
Click here to add this to my saved trials
Albany, New York 12208
515
mi
from 43215
Albany, NY
Click here to add this to my saved trials
Asheville, North Carolina 28806
304
mi
from 43215
Asheville, NC
Click here to add this to my saved trials
Atlanta, Georgia 30329
436
mi
from 43215
Atlanta, GA
Click here to add this to my saved trials
Augusta, Georgia 29841
449
mi
from 43215
Augusta, GA
Click here to add this to my saved trials
Baltimore, Maryland 21201
343
mi
from 43215
Baltimore, MD
Click here to add this to my saved trials
Boca Raton, Florida 33486
955
mi
from 43215
Boca Raton, FL
Click here to add this to my saved trials
Boston, Massachusetts 02215
641
mi
from 43215
Boston, MA
Click here to add this to my saved trials
Calgary, Alberta
1670
mi
from 43215
Calgary,
Click here to add this to my saved trials
Charleston, South Carolina 29401
525
mi
from 43215
Charleston, SC
Click here to add this to my saved trials
Chicago, Illinois 60611
274
mi
from 43215
Chicago, IL
Click here to add this to my saved trials
Cincinnati, Ohio 45267
97
mi
from 43215
Cincinnati, OH
Click here to add this to my saved trials
Cleveland, Ohio 44195
126
mi
from 43215
Cleveland, OH
Click here to add this to my saved trials
Dallas, Texas 75390
912
mi
from 43215
Dallas, TX
Click here to add this to my saved trials
Danbury, Connecticut 06810
510
mi
from 43215
Danbury, CT
Click here to add this to my saved trials
Des Moines, Iowa 50309
565
mi
from 43215
Des Moines, IA
Click here to add this to my saved trials
Durham, North Carolina 27705
354
mi
from 43215
Durham, NC
Click here to add this to my saved trials
Englewood, Colorado 80113
1162
mi
from 43215
Englewood, CO
Click here to add this to my saved trials
Fountain Valley, California 92708
1966
mi
from 43215
Fountain Valley, CA
Click here to add this to my saved trials
Houston, Texas 77030
995
mi
from 43215
Houston, TX
Click here to add this to my saved trials
Irvine, California 92697
1960
mi
from 43215
Irvine, CA
Click here to add this to my saved trials
Jacksonville, Florida 32209
667
mi
from 43215
Jacksonville, FL
Click here to add this to my saved trials
Kansas City, Kansas 66160
620
mi
from 43215
Kansas City, KS
Click here to add this to my saved trials
Los Angeles, California 90048
1972
mi
from 43215
Los Angeles, CA
Click here to add this to my saved trials
Minneapolis, Minnesota 55414
625
mi
from 43215
Minneapolis, MN
Click here to add this to my saved trials
New York, New York 10032
481
mi
from 43215
New York, NY
Click here to add this to my saved trials
New York, New York 10032
481
mi
from 43215
New York, NY
Click here to add this to my saved trials
Oxnard, California 93030
2017
mi
from 43215
Oxnard, CA
Click here to add this to my saved trials
Panama City, Florida 32405
693
mi
from 43215
Panama City, FL
Click here to add this to my saved trials
Pasadena, California 91104
1964
mi
from 43215
Pasadena, CA
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19107
416
mi
from 43215
Philadelphia, PA
Click here to add this to my saved trials
Phoenix, Arizona 85004
1662
mi
from 43215
Phoenix, AZ
Click here to add this to my saved trials
Port Charlotte, Florida 33980
899
mi
from 43215
Port Charlotte, FL
Click here to add this to my saved trials
Reseda, California 91335
1983
mi
from 43215
Reseda, CA
Click here to add this to my saved trials
St. Louis, Missouri 63110
397
mi
from 43215
St. Louis, MO
Click here to add this to my saved trials
Sun City, Arizona 85351
1668
mi
from 43215
Sun City, AZ
Click here to add this to my saved trials
Sunnyvale, California 94085
2094
mi
from 43215
Sunnyvale, CA
Click here to add this to my saved trials
Tampa, Florida 33647
830
mi
from 43215
Tampa, FL
Click here to add this to my saved trials
Toledo, Ohio 43614
117
mi
from 43215
Toledo, OH
Click here to add this to my saved trials
Torrance, California 90505
1983
mi
from 43215
Torrance, CA
Click here to add this to my saved trials
Tucson, Arizona 85724
1639
mi
from 43215
Tucson, AZ
Click here to add this to my saved trials
West Bloomfield, Michigan 48322
178
mi
from 43215
West Bloomfield, MI
Click here to add this to my saved trials