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
38
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72 East Concord Street
Boston, Massachusetts 02118
(617) 638-5300
Phone: 617-638-8456
Boston University School of Medicine A leader in medical education and research, Boston University School...
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Los Angeles, California 90033
213) 740-2311
Phone: 323-442-8029
University of Southern California The University of Southern California is one of the world’s leading...
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Asheville, North Carolina 28806
Phone: 828-210-9311
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Aurora, Colorado 80045
Phone: 303-724-2194
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Bedford, Texas 76201
Phone: 214-432-7549
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Birmingham, Alabama 35233
Phone: 205-934-0074
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Boca Raton, Florida 33486
Phone: 561-392-1818
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Phone: 843-792-8327
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Charlottesville, Virginia 22911
Phone: 434-293-0866
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Phone: 312-563-2900
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
Phone: 513-558-4035
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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Commack, New York 11725
Phone: 631-462-7774
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East Lansing, Michigan 48824
Phone: 517-432-9277
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Farmington Hills, Michigan 48334
Phone: 248-957-8940
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Fountain Valley, California 92708
Phone: 714-378-5033
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500 University Dr
Hershey, Pennsylvania 17033
(717) 531-6955
Phone: 717-531-3828
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
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Houston, Texas 77030
Phone: 713-798-6556
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Kansas City, Kansas 66160
Phone: 913-588-6782
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Kirkland, Washington 98034
Phone: 425-899-5374
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Lebanon, New Hampshire 03756
Phone: 603-650-3834
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11234 Anderson St
Loma Linda, California 92354
(909) 558-4000
Phone: 909-558-2037
Loma Linda University Medical Center An outgrowth of the original Sanitarium on the hill in...
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Naples, Florida 34102
Phone: 239-434-0332
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1211 Medical Center Drive
Nashville, Tennessee 37232
Phone: 615-322-2538
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New York, New York 10021
Phone: 212-746-4086
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New York, New York 10016
Phone: 646-501-9273
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100 West Gore Street
Orlando, Florida 32806
Phone: 407-210-1337
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Pasadena, California 91105
Phone: 626-250-2070
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240 West Thomas Road
Phoenix, Arizona 85013
Phone: 602-406-2014
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Pleven,
Phone: +359878885861
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1060 East Foothill Boulevard
Reseda, California 91335
Phone: 626-250-2070
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99 Beauvoir Avenue
Summit, New Jersey 07902
Phone: 908-522-3501
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Sun City, Arizona 85351
Phone: 623-832-6500
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Tampa, Florida 33613
Phone: 813-396-0768
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2801 W. Bancroft
Toledo, Ohio 43606
419.530.4636
Phone: 419-383-6721
University of Toledo The University of Toledo is one of 14 state universities in Ohio....
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Tulsa, Oklahoma 74136
Phone: 918-392-4530
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35 Talcottville Road
Vernon, Connecticut 06066
Phone: 860-870-6385
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Virginia Beach, Virginia 23456
Phone: 757-507-0600
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West Bloomfield, Michigan 48322
Phone: 248-661-6540
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