An Open-label Extension Study of the Safety and Clinical Utility of IPX203 in Parkinson’s Disease Patients With Motor Fluctuations
in the treatment of subjects with advanced Parkinson’s disease (PD) who have motor
– Successfully completed Study IPX203-B16-02
– Able to provide written informed consent prior to the conduct of any study-specific
– Female subjects 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.
– 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
– 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.
– Subjects who, in the opinion of the clinical investigator, should not participate in
- University of California, Irvine – Clinical Trials Unit (132), Irvine, California, United States, 92697
- Hoag Memorial Hospital Presbyterian (134), Newport Beach, California, United States, 92663
- SC3 Research-Pasadena (148), Pasadena, California, United States, 91105
- SC3 Research-Reseda (146), Reseda, California, United States, 91335