An Open-label Extension Study of the Safety and Clinical Utility of IPX203 in Parkinson’s Disease Patients With Motor Fluctuations
Sponsor:
Brief Summary:
in the treatment of subjects with advanced Parkinson’s disease (PD) who have motor
fluctuations.
Criteria
– Successfully completed Study IPX203-B16-02
– Able to provide written informed consent prior to the conduct of any study-specific
procedures.
– 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
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.
– Subjects who, in the opinion of the clinical investigator, should not participate in
the study.
Locations
- 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