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



Status:Enrolling by invitation
Conditions:Parkinsons Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:40 - Any
Updated:3/27/2019
Start Date:April 4, 2019
End Date:March 31, 2021

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

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.

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.

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.
We found this trial at
1
site
Farmington Hills, Michigan 48334
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Farmington Hills, MI
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