A Study of AP-CD/LD in Fluctuating Parkinson's Disease Patients Who Completed IN 11 004



Status:Recruiting
Conditions:Parkinsons Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:30 - 100
Updated:8/16/2018
Start Date:July 2016
End Date:December 2019

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An Open-Label,Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects Who Completed Study IN 11 004

The purpose of this study is to allow evaluation of long-term clinical effect and safety
outcome of treatment with AP-CD/LD, as well as to allow patients to benefit from extended
treatment duration with AP-CD/LD after they have successfully completed the Phase 3 core
study IN 11 004 ('core study', a phase III, multicenter, randomized, double-blind,
double-dummy, active-controlled Phase 3 study to assess the safety and efficacy of AP CD/LD
versus IR CD/LD in fluctuating PD patients).

This will be a multi-center, global, open-label study in adult suffering from fluctuating
Parkinson's disease subjects who have successfully completed the core study IN 11 004.

After signing informed consent and meeting inclusion/exclusion criteria, eligible subjects
will be enrolled into a 12-month open-label extension and receive the AP-CD/LD as needed.

Efficacy and safety will be assessed throughout the study period.

Inclusion Criteria:

1. Subjects who successfully completed the core study IN 11 004 and, in the opinion of
the Investigator, would benefit from long-term treatment with AP-CD/LD

2. Continue to carry the diagnosis of Parkinson's disease consistent with UK brain bank
criteria

3. Has a good response to Levodopa in the opinion of the investigator

4. Subjects able and willing to give written (signed and dated) informed consent to
participate in the study

Exclusion Criteria:

1. Participation in another clinical trial other than IN 11 004 and receipt of an
investigational medication other than that administered in the context of IN 11 004
within 28 days prior to the planned start of treatment

2. Previous or planned neurosurgical or Duodopa treatment for Parkinson's Disease (e.g.,
procedures including ablation or deep brain stimulation)

3. Non-selective monoamine oxidase (MAO) inhibitors within 28 days prior to Baseline
Visit or planned administration during study participation

4. If, in the opinion of the Investigator, subject should not participate in the study

5. Women who are pregnant or nursing. Women of childbearing potential who are not willing
to use a medically acceptable method of contraception.
We found this trial at
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Kirkland, Washington 98034
Phone: 425-899-5374
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72 East Concord Street
Boston, Massachusetts 02118
(617) 638-5300
Phone: 617-638-8456
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Los Angeles, California 90033
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Phone: 323-442-8029
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Asheville, North Carolina 28806
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Aurora, Colorado 80045
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Bedford, Texas 76201
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Birmingham, Alabama 35233
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Boca Raton, Florida 33486
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
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Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Charlottesville, Virginia 22911
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Phone: 312-563-2900
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
Phone: 513-558-4035
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Commack, New York 11725
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East Lansing, Michigan 48824
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Farmington Hills, Michigan 48334
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Fountain Valley, California 92708
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500 University Dr
Hershey, Pennsylvania 17033
(717) 531-6955
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Houston, Texas 77030
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Kansas City, Kansas 66160
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Lebanon, New Hampshire 03756
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11234 Anderson St
Loma Linda, California 92354
(909) 558-4000
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Naples, Florida 34102
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1211 Medical Center Drive
Nashville, Tennessee 37232
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New York, New York 10021
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New York, New York 10016
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100 West Gore Street
Orlando, Florida 32806
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Pasadena, California 91105
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Phoenix, Arizona 85013
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Reseda, California 91335
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99 Beauvoir Avenue
Summit, New Jersey 07902
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2801 W. Bancroft
Toledo, Ohio 43606
419.530.4636
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University of Toledo The University of Toledo is one of 14 state universities in Ohio....
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Tulsa, Oklahoma 74136
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35 Talcottville Road
Vernon, Connecticut 06066
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Virginia Beach, Virginia 23456
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West Bloomfield, Michigan 48322
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