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

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

ArmDescriptionAssigned 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.
  • Drug: IPX203 140 mg
    35 mg - 140 mg CD-LD extended release capsules
    Other names:
    • IPX203 35-140 mg
  • Drug: IPX203 210 mg
    52.5 mg - 210 mg CD-LD extended release capsules
    Other names:
    • IPX203 52.5-210 mg
  • Drug: IPX203 280 mg
    70 mg - 280 mg CD-LD extended release capsules
    Other names:
    • IPX203 70-280mg
  • Drug: IPX203 350 mg
    87.5 mg - 350 mg CD-LD extended release capsules
    Other names:
    • IPX203 87.5-350mg

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.