An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects With Parkinson's Disease



Status:Completed
Conditions:Parkinsons Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:30 - Any
Updated:4/21/2016
Start Date:March 2010
End Date:October 2011

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

The purpose of this study is to determine the long term safety and clinical utility of
IPX066 in subjects with Parkinson's Disease.

IPX066 is intended for chronic treatment of motor symptoms for all stages of PD. This study
is designed to enroll subjects who have successfully completed one of the following studies
of IPX066:

- IPX066-B08-05 (A Placebo-Controlled Study to Evaluate the Safety and Efficacy of IPX066
in Subjects with Parkinson's Disease)

- IPX066-B08-11 (A Study to Compare Pharmacokinetics and Pharmacodynamics of IPX066 to
Standard Carbidopa - Levodopa)

- IPX066-B09-02 (A Study to Evaluate the Safety and Efficacy of IPX066 in Advanced
Parkinson's Disease)

All participants will be given IPX066 for 9 months.

Inclusion Criteria:

- Each subject must meet the following inclusion criteria in order to be enrolled in
the study:

1. Successful completion of studies IPX066-B08-05, IPX066-B08-11, or IPX066-B09-02.

2. In the opinion of the Investigator, the Parkinson's disease diagnosis is still
valid and the subject remains eligible for LD therapy.

Exclusion Criteria:

- Each subject must be free of the following exclusion criteria in order to be enrolled
in the study:

1. Received an investigational medication other than those from an IPX066 trial
within 4 weeks prior to the planned start of treatment.

2. Anticipates functional neurosurgical treatment for PD (e.g., ablation or deep
brain stimulation) during study participation.

3. Received within 4 weeks prior to Baseline Visit or planning to take during study
participation: nonselective monoamine oxidase (MAO) inhibitors (with the
exception of rasagiline).

4. In the opinion of the Investigator, should not participate in the study.
We found this trial at
37
sites
6701 Country Club Drive
Golden Valley, Minnesota 55427
888-993-5495
?
mi
from
Golden Valley, MN
Click here to add this to my saved trials
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
3924 9th Avenue West
Bradenton, Florida 34205
?
mi
from
Bradenton, FL
Click here to add this to my saved trials
1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
?
mi
from
Houston, TX
Click here to add this to my saved trials
104 SE 1st Avenue
Ocala, Florida 34471
352-629-5800
?
mi
from
Ocala, FL
Click here to add this to my saved trials
?
mi
from
Albany, NY
Click here to add this to my saved trials
?
mi
from
Augusta, GA
Click here to add this to my saved trials
Bingham Farms, Michigan 48025
?
mi
from
Bingham Farms, MI
Click here to add this to my saved trials
?
mi
from
Boise, ID
Click here to add this to my saved trials
171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
?
mi
from
Charleston, SC
Click here to add this to my saved trials
1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Cincinatti, Ohio 45219
?
mi
from
Cincinatti, OH
Click here to add this to my saved trials
Commack, New York 11725
?
mi
from
Commack, NY
Click here to add this to my saved trials
1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
?
mi
from
Dallas, TX
Click here to add this to my saved trials
1200 Pleasant St
Des Moines, Iowa 50309
(515) 241-6212
Iowa Methodist Medical Center Iowa Methodist Medical Center was established in 1901 in a single...
?
mi
from
Des Moines, IA
Click here to add this to my saved trials
?
mi
from
Durham, NC
Click here to add this to my saved trials
Hollywood, Florida 33021
?
mi
from
Hollywood, FL
Click here to add this to my saved trials
3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
?
mi
from
Kansas City, KS
Click here to add this to my saved trials
La Jolla, California 92037
?
mi
from
La Jolla, CA
Click here to add this to my saved trials
La Jolla, California 92037
?
mi
from
La Jolla, CA
Click here to add this to my saved trials
Little Rock, Arkansas 72205
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
?
mi
from
London,
Click here to add this to my saved trials
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
?
mi
from
New Brunswick, NJ
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
Phoenix, Arizona 85050
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Phoenix, Arizona 85013
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
?
mi
from
Port Charlotte, FL
Click here to add this to my saved trials
Saint Petersburg, Florida 33713
?
mi
from
Saint Petersburg, FL
Click here to add this to my saved trials
Sunnyvale, California 94089
?
mi
from
Sunnyvale, CA
Click here to add this to my saved trials
Syracuse, New York 13210
?
mi
from
Syracuse, NY
Click here to add this to my saved trials
Tacoma, Washington 98405
?
mi
from
Tacoma, WA
Click here to add this to my saved trials
?
mi
from
Tampa, FL
Click here to add this to my saved trials
2801 W. Bancroft
Toledo, Ohio 43606
419.530.4636
University of Toledo The University of Toledo is one of 14 state universities in Ohio....
?
mi
from
Toledo, OH
Click here to add this to my saved trials
Torrance, California 90502
?
mi
from
Torrance, CA
Click here to add this to my saved trials
?
mi
from
Tulsa, OK
Click here to add this to my saved trials