Clareo Health | Open Label Extension (OLE) Study of the Safety and Clinical Utility of IPX203 in Parkinson's Disease (PD) Participants With Motor Fluctuations
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Impax Laboratories, LLC
This is a 9-month, multicenter open-label safety extension study. Participants who have successfully completed Study NCT03670953 \[A Randomized Controlled Study to Compare the Safety and Efficacy of IPX203 with Immediate-Release (IR) Carbidopa-Levodopa (CD-LD) in Parkinson's Disease Patients with Motor Fluctuations\] may have the opportunity to enroll in this open-label study.
Age
40–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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.
