Status:
COMPLETED
Open Label Extension (OLE) Study of the Safety and Clinical Utility of IPX203 in Parkinson's Disease (PD) Participants With Motor Fluctuations
Lead Sponsor:
Impax Laboratories, LLC
Conditions:
Parkinson Disease
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the long-term safety and clinical utility of IPX203 in the treatment of participants with advanced Parkinson's disease (PD) who have motor fluctuations.
Detailed Description
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 I...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
April 3 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 21 2022
Estimated Enrollment :
419 Patients enrolled
Trial Details
Trial ID
NCT03877510
Start Date
April 3 2019
End Date
March 21 2022
Last Update
July 13 2023
Active Locations (98)
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Xenoscience, Inc (102)
Phoenix, Arizona, United States, 85004
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University of Arkansas for Medical Sciences (117)
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