Open Label Extension (OLE) Study of the Safety and Clinical Utility of IPX203 in Parkinson's Disease (PD) Participants With Motor Fluctuations

Completed · Phase 3

Conditions studied: Parkinson Disease

In brief

The purpose of this study is to evaluate the long-term safety and clinical utility of IPX203 in the treatment of participants with advanced Parkinson's disease (PD) who have motor fluctuations.

Key facts

Study ID

NCT03877510

Run by

Impax Laboratories, LLC

People needed

419

Starts

2019-04-03

Expected to finish

2022-03-21

Last updated by the study team

2023-07-13

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Successfully completed Study IPX203-B16-02
• Able to provide written informed consent prior to the conduct of any study-specific procedures.
• Female participants of childbearing potential must have a negative urine pregnancy test at the baseline visit (Visit 1).
• Agrees to use a medically acceptable method of contraception throughout the study and for 6 weeks after completing the study.

You may not qualify if…

• Intends to use any doses of Rytary® or Duopa™ during this study.
• Plans to use an investigational treatment other than IPX203 during the course of this study.
• Neurosurgical ablation treatment for PD is planned or anticipated during the study period. Implantation of a deep brain stimulator (DBS) for the treatment of PD is permitted during this study.
• Participants who, in the opinion of the clinical investigator, should not participate in the study.

Where it is running

• St. Joseph's Hospital & Medical Center - Barrow Neurological Institute (156) — Phoenix, Arizona, United States
• Clinical Trials, Inc (113) — Little Rock, Arkansas, United States
• University of Arkansas for Medical Sciences (117) — Little Rock, Arkansas, United States
• Keek School of Medicine of USC/ University of Southern California (106) — Los Angeles, California, United States
• Hoag Memorial Hospital Presbyterian (134) — Newport Beach, California, United States
• SC3 Research-Pasadena (148) — Pasadena, California, United States
• SC3 Research-Reseda (146) — Reseda, California, United States
• University of Colorado Hospital Anschutz Outpatient Pavilion (120) — Aurora, Colorado, United States
• Rocky Mountain Movement Disorders (116) — Englewood, Colorado, United States
• ChristianaCare Neurology Specialists (153) — Newark, Delaware, United States
• JEM Research Institute (136) — Atlantis, Florida, United States
• Visionary Investigators Network (168) — Aventura, Florida, United States
• UHealth at Boca Raton (152) — Boca Raton, Florida, United States
• Parkinson's Disease and Movement Disorders Center of Boca Raton (121) — Boca Raton, Florida, United States
• Infinity Clinical Research LLC (104) — Hollywood, Florida, United States
• University of Florida Health Science Center (129) — Jacksonville, Florida, United States
• Neurology Associates, P.A. (125) — Maitland, Florida, United States
• University of Miami (149) — Miami, Florida, United States
• Medical Professional Clinical Research Center, Inc. (163) — Miami, Florida, United States
• Parkinson's Disease Treatment Center of Southwest Florida (131) — Port Charlotte, Florida, United States
• Infinity Clinical Research, LLC (105) — Sunrise, Florida, United States
• University of South Florida (114) — Tampa, Florida, United States
• Premiere Research Institute at Palm Beach Neurology (174) — West Palm Beach, Florida, United States
• Charter Research (166) — Winter Park, Florida, United States
• Xenoscience, Inc (102) — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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