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

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

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
sites
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...
1726
mi
from 91732
Chicago, IL
Click here to add this to my saved trials
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...
2577
mi
from 91732
Boston, MA
Click here to add this to my saved trials
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...
11
mi
from 91732
Los Angeles, CA
Click here to add this to my saved trials
Asheville, North Carolina 28806
Phone: 828-210-9311
2000
mi
from 91732
Asheville, NC
Click here to add this to my saved trials
Aurora, Colorado 80045
Phone: 303-724-2194
825
mi
from 91732
Aurora, CO
Click here to add this to my saved trials
Bedford, Texas 76201
Phone: 214-432-7549
1204
mi
from 91732
Bedford, TX
Click here to add this to my saved trials
Birmingham, Alabama 35233
Phone: 205-934-0074
1785
mi
from 91732
Birmingham, AL
Click here to add this to my saved trials
Boca Raton, Florida 33486
Phone: 561-392-1818
2311
mi
from 91732
Boca Raton, FL
Click here to add this to my saved trials
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...
2184
mi
from 91732
Charleston, SC
Click here to add this to my saved trials
Charlottesville, Virginia 22911
Phone: 434-293-0866
2211
mi
from 91732
Charlottesville, VA
Click here to add this to my saved trials
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...
1880
mi
from 91732
Cincinnati, OH
Click here to add this to my saved trials
Commack, New York 11725
Phone: 631-462-7774
2470
mi
from 91732
Commack, NY
Click here to add this to my saved trials
East Lansing, Michigan 48824
Phone: 517-432-9277
1897
mi
from 91732
East Lansing, MI
Click here to add this to my saved trials
Farmington Hills, Michigan 48334
Phone: 248-957-8940
1952
mi
from 91732
Farmington Hills, MI
Click here to add this to my saved trials
Fountain Valley, California 92708
Phone: 714-378-5033
25
mi
from 91732
Fountain Valley, CA
Click here to add this to my saved trials
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...
2296
mi
from 91732
Hershey, PA
Click here to add this to my saved trials
Houston, Texas 77030
Phone: 713-798-6556
1358
mi
from 91732
Houston, TX
Click here to add this to my saved trials
Kansas City, Kansas 66160
Phone: 913-588-6782
1332
mi
from 91732
Kansas City, KS
Click here to add this to my saved trials
Kirkland, Washington 98034
Phone: 425-899-5374
967
mi
from 91732
Kirkland, WA
Click here to add this to my saved trials
Lebanon, New Hampshire 03756
Phone: 603-650-3834
2515
mi
from 91732
Lebanon, NH
Click here to add this to my saved trials
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...
43
mi
from 91732
Loma Linda, CA
Click here to add this to my saved trials
Naples, Florida 34102
Phone: 239-434-0332
2220
mi
from 91732
Naples, FL
Click here to add this to my saved trials
1211 Medical Center Drive
Nashville, Tennessee 37232
Phone: 615-322-2538
1762
mi
from 91732
Nashville, TN
Click here to add this to my saved trials
New York, New York 10021
Phone: 212-746-4086
2435
mi
from 91732
New York, NY
Click here to add this to my saved trials
New York, New York 10016
Phone: 646-501-9273
2351
mi
from 91732
New York, NY
Click here to add this to my saved trials
100 West Gore Street
Orlando, Florida 32806
Phone: 407-210-1337
2184
mi
from 91732
Orlando, FL
Click here to add this to my saved trials
Pasadena, California 91105
Phone: 626-250-2070
9
mi
from 91732
Pasadena, CA
Click here to add this to my saved trials
240 West Thomas Road
Phoenix, Arizona 85013
Phone: 602-406-2014
343
mi
from 91732
Phoenix, AZ
Click here to add this to my saved trials
Pleven,
Phone: +359878885861
?
mi
from 91732
Pleven,
Click here to add this to my saved trials
1060 East Foothill Boulevard
Reseda, California 91335
Phone: 626-250-2070
21
mi
from 91732
Reseda, CA
Click here to add this to my saved trials
99 Beauvoir Avenue
Summit, New Jersey 07902
Phone: 908-522-3501
2414
mi
from 91732
Summit, NJ
Click here to add this to my saved trials
Sun City, Arizona 85351
Phone: 623-832-6500
330
mi
from 91732
Sun City, AZ
Click here to add this to my saved trials
Tampa, Florida 33613
Phone: 813-396-0768
2132
mi
from 91732
Tampa, FL
Click here to add this to my saved trials
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....
1932
mi
from 91732
Toledo, OH
Click here to add this to my saved trials
Tulsa, Oklahoma 74136
Phone: 918-392-4530
1253
mi
from 91732
Tulsa, OK
Click here to add this to my saved trials
35 Talcottville Road
Vernon, Connecticut 06066
Phone: 860-870-6385
2506
mi
from 91732
Vernon, CT
Click here to add this to my saved trials
Virginia Beach, Virginia 23456
Phone: 757-507-0600
2350
mi
from 91732
Virginia Beach, VA
Click here to add this to my saved trials
West Bloomfield, Michigan 48322
Phone: 248-661-6540
1952
mi
from 91732
West Bloomfield, MI
Click here to add this to my saved trials