Long Term Study of Istradefylline in Subjects With Moderate to Severe Parkinson's Disease



Status:Completed
Conditions:Parkinsons Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:30 - Any
Updated:3/29/2019
Start Date:December 2015
End Date:December 20, 2017

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A Phase 3, Long-term, Open-label Study of Istradefylline in Subjects With Moderate to Severe Parkinson's Disease

This is a Phase 3, 52-week, open-label, flexible-dose, multinational, multicenter study to
evaluate the safety and tolerability of istradefylline 20 or 40 mg/d in subjects with
moderate to severe PD with motor fluctuations and dyskinesia on levodopa combination
(levodopa/carbidopa or levodopa/benserazide) therapy plus at least one adjunctive PD
medication. Subjects who completed 12 weeks of double-blind treatment and the 30-day
follow-up period in Study No. 6002-014 will undergo Screening and Baseline evaluations for
eligibility for the study. Eligible subjects will be treated with istradefylline at a
starting dose of 20 mg/d with an option for a dose adjustment to 40 mg/d at Week 12 based on
the Investigator's judgment of each subject's response and tolerability. If deemed necessary,
one unscheduled dose adjustment visit between Week 2 to Week 12 is allowed in accordance with
clinical judgment of the Investigator. Subjects who had a dose adjustment to 40 mg/d can have
their dose decreased to 20 mg/d by the Investigator at a second unscheduled dose adjustment
visit if there are tolerability issues. The istradefylline dose should remain fixed between
Week 26 to Week 52. Consultation with the Sponsor's Medical Monitor is required prior to any
unscheduled dose adjustment visits. A subject may discontinue from the study at any time.


Inclusion Criteria:

1. Written informed consent;

2. Subjects who completed Study No. 6002-014 inclusive of the 30-day follow-up period;

3. Currently taking levodopa combination (carbidopa/levodopa or benserazide/levodopa)
therapy plus at least one adjunctive PD medication;

4. Women of child-bearing potential (WOCBP) must use a reliable method of contraception
and have a negative serum pregnancy test at Screening;

Exclusion Criteria:

1. Subjects with less than 70% treatment compliance throughout their enrollment on Study
No 6002-014 and or with major protocol deviations in Study No. 6002-014 (subjects who
failed to meet any of the inclusion criteria, subjects who met any of the exclusion
criteria or subjects who met the criteria for subject withdrawal but who were not
withdrawn);

2. Subjects on apomorphine and/or dopamine receptor antagonists or direct
gastrointestinal levodopa infusion;

3. Subject who have had neurosurgical operation for PD;

4. Subjects taking A2a antagonist, potent CYP3A4 inhibitors, potent CYP34A inducers;

5. Subjects who have had a diagnosis of cancer or evidence of continued malignancy within
the past three years (with the exception of adequately treated basal cell or squamous
cell skin cancer, in situ cervical cancer, or in situ prostate cancer with normal
prostate-specific antigens post resection).
We found this trial at
24
sites
Durham, North Carolina 27705
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Durham, NC
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Albany, New York 12208
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Albany, NY
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Asheville, North Carolina 28806
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Asheville, NC
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Atlanta, Georgia 30329
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Atlanta, GA
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Augusta, Georgia 29841
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Augusta, GA
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Boca Raton, Florida 33486
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Boca Raton, FL
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Boston, Massachusetts 02215
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Boston, MA
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Calgary, Alberta
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Calgary,
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Danbury, Connecticut 06810
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Danbury, CT
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Des Moines, Iowa 50309
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Des Moines, IA
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Englewood, Colorado 80113
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Englewood, CO
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Fountain Valley, California 92708
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Fountain Valley, CA
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Kansas City, Kansas 66160
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Kansas City, KS
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Los Angeles, California 90048
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Los Angeles, CA
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New York, New York 10032
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New York, NY
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Oxnard, California 93030
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Oxnard, CA
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Phoenix, Arizona 85004
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Phoenix, AZ
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Port Charlotte, Florida 33980
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Port Charlotte, FL
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Sun City, Arizona 85351
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Sun City, AZ
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Tampa, Florida 33647
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Tampa, FL
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Toledo, Ohio 43614
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Toledo, OH
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Torrance, California 90505
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Torrance, CA
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Tucson, Arizona 85724
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Tucson, AZ
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West Bloomfield, Michigan 48322
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West Bloomfield, MI
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