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 |
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.
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.
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.
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