Open Label Extension (OLE) Study of the Safety and Clinical Utility of IPX203 in Parkinson's Disease (PD) Participants With Motor Fluctuations

Impax Laboratories

Status and phase: Completed; Phase 3

Conditions: Parkinson Disease

Treatments: Drug: IPX203

Study type: Interventional

Funder types: Industry

Identifiers

NCT03877510

IPX203-B16-03

2018-002234-21 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 419 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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419 participants in 1 patient group

Open Label IPX203

Experimental group

Description:

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.

Treatment:

Drug: IPX203