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

Completed · Phase 3

Conditions studied: Parkinson's Disease

In brief

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

Key facts

Study ID

NCT01096186

Run by

Impax Laboratories, LLC

People needed

617

Starts

2010-03-01

Expected to finish

2011-10-01

Last updated by the study team

2019-11-08

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Each subject must meet the following inclusion criteria in order to be enrolled in the study:
• Successful completion of studies IPX066-B08-05, IPX066-B08-11, or IPX066-B09-02.
• In the opinion of the Investigator, the Parkinson's disease diagnosis is still valid and the subject remains eligible for LD therapy.

You may not qualify if…

• Each subject must be free of the following exclusion criteria in order to be enrolled in the study:
• Received an investigational medication other than those from an IPX066 trial within 4 weeks prior to the planned start of treatment.
• Anticipates functional neurosurgical treatment for PD (e.g., ablation or deep brain stimulation) during study participation.
• 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).
• In the opinion of the Investigator, should not participate in the study.

Where it is running

• Mohammed Ali Parkinson's Center — Phoenix, Arizona, United States
• HOPE Research Institute — Phoenix, Arizona, United States
• Clinical Trials Inc. — Little Rock, Arkansas, United States
• Coastal Neurological Medical Group — La Jolla, California, United States
• Coordinated Clinical Research — La Jolla, California, United States
• The Parkinson's Institute — Sunnyvale, California, United States
• Collaborative NeuroScience Network, Inc. — Torrance, California, United States
• Bradenton Research Center, Inc. — Bradenton, Florida, United States
• Sunrise Clinical Research — Hollywood, Florida, United States
• Renstar Medical Research — Ocala, Florida, United States
• Charlotte Neurological Services Parkinson's Disease Treatment Center of S.W. Florida — Port Charlotte, Florida, United States
• Suncoast Neuroscience Associates, Inc. — St. Petersburg, Florida, United States
• University of South Florida, Parkinson's Disease and Movement Disorders Center — Tampa, Florida, United States
• Medical College of Georgia, Movements Disorders Clinic — Augusta, Georgia, United States
• Movement Disorder Center at Idaho Elks Rehabilitation Hospital — Boise, Idaho, United States
• Northwestern University, Feinberg School of Medicine, Dept. of Neurology — Chicago, Illinois, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Iowa Methodist Medical Center — Des Moines, Iowa, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Quest Research Institute — Bingham Farms, Michigan, United States
• Struthers Parkinson's Center — Golden Valley, Minnesota, United States
• UMDNJ Robert Wood Johnson Medical Center, Department of Neurology — New Brunswick, New Jersey, United States
• Albany Medical College, Parkinson's Disease and Movement Disorders Center — Albany, New York, United States
• David L. Kreitzman, MD, P.C. — Commack, New York, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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