This study is accepting new patients by invitation only

Open Label Extension (OLE) Study of the Safety and Clinical Utility of IPX203 in PD Patients With Motor Fluctuations

a study on Parkinson's Disease

Summary

Eligibility
for people ages 40 years and up (full criteria)
Location
at Irvine, California and other locations
Dates
study started
estimated completion

Description

Summary

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.

Official Title

An Open-label Extension Study of the Safety and Clinical Utility of IPX203 in Parkinson's Disease Patients With Motor Fluctuations

Details

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.

Keywords

Parkinson Disease motor fluctuations IPX203 IPX203 140 mg IPX203 210 mg IPX203 280 mg IPX203 350 mg Open Label IPX203

Eligibility

You can join if…

Open to people ages 40 years and up

  • 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.

You CAN'T join if...

  • 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.

Locations

  • University of California, Irvine - Clinical Trials Unit (132)
    Irvine California 92697 United States
  • Hoag Memorial Hospital Presbyterian (134)
    Newport Beach California 92663 United States

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
Impax Laboratories, LLC
ID
NCT03877510
Phase
Phase 3
Study Type
Interventional
Last Updated