Open Label Extension (OLE) Study of the Safety and Clinical Utility of IPX203 in PD Patients With Motor Fluctuations
Purpose
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.
Condition
- Parkinson Disease
Eligibility
- Eligible Ages
- Over 40 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Open Label IPX203 |
Subjects will receive IPX203 140 mg, IPX203 210 mg, IPX203 280 mg, or IPX203 350 mg for approximately 9 months. The dose and dosing frequency will be determined by the investigator. |
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Recruiting Locations
More Details
- NCT ID
- NCT03877510
- Status
- Enrolling by invitation
- Sponsor
- Impax Laboratories, LLC
Detailed 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 Fluctuations] may have the opportunity to enroll in this open-label study.