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 |
The purpose of this study is to determine the long term safety and clinical utility of
IPX066 in subjects with Parkinson's Disease.
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.
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
Port Charlotte, Florida 33980
Click here to add this to my saved trials
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
Click here to add this to my saved trials
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
Click here to add this to my saved trials
Iowa Methodist Medical Center Iowa Methodist Medical Center was established in 1901 in a single...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
University of Toledo The University of Toledo is one of 14 state universities in Ohio....
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials