Open Label Extension (OLE) Study of the Safety and Clinical Utility of IPX203 in Parkinson's Disease (PD) Participants 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 participants 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 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 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. - Participants 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 |
All participants received oral administration of extended-release capsules IPX203 dosing regimen that was determined at the end of the IPX203 dose conversion period of Study IPX203-B16-02 (NCT03670953) for nine months of open-label therapy. The dose and dosing frequency was determined by the investigator to achieve the optimal balance of efficacy and safety. |
|
Recruiting Locations
More Details
- NCT ID
- NCT03877510
- Status
- Completed
- Sponsor
- Impax Laboratories, LLC
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 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.