Open Label Extension (OLE) Study of the Safety and Clinical Utility of IPX203 in PD Patients With Motor Fluctuations
Last updated on July 2021Recruitment
- Recruitment Status
- Enrolling by invitation
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Parkinson Disease
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 40 years and 125 years
- Gender
- Both males and females
Description
This is a 9-month, multicenter open-label safety extension study. Subjects who have successfully completed Study IPX203-B16-02 [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...
This is a 9-month, multicenter open-label safety extension study. Subjects who have successfully completed Study IPX203-B16-02 [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.
Tracking Information
- NCT #
- NCT03877510
- Collaborators
- Not Provided
- Investigators
- Study Director: Impax Impax Study Director Impax Laboratories, LLC
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