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An Open-label Extension Study of the Safety and Clinical Utility of IPX203 in Parkinson’s Disease Patients With Motor Fluctuations


Brief Summary:

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


Inclusion Criteria:

– 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.

Exclusion Criteria:

– 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
the study.


  • 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
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