Open Label Extension (OLE) Study of the Safety and Clinical Utility of IPX203 in PD Patients With Motor Fluctuations

• Status: Enrolling by invitation
• Trial end date: 2022-02-28
• Target enrollment: 0
• Participant gender: All

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 fluctuations.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: IMPAX Laboratories, Inc.; Impax Laboratories, LLC

Criteria

Inclusion 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.