A Study to Assess the PK and Pharmacodynamics of IPX203 in Patients With Advanced Parkinson's Disease
Parkinson's Disease
About this trial
This is an interventional treatment trial for Parkinson's Disease
Eligibility Criteria
Inclusion Criteria:
Male or female subjects diagnosed with idiopathic PD with motor complications, who are currently being treated chronically with stable regimens of CD-LD.
Requiring at least 400 mg but not more than 1600 mg LD per day during the waking hours; and at least 100 mg but not more than 250 mg LD from IR CD-LD for the first morning dose.
Dosing frequency of IR CD-LD of at least 4 times daily excluding nighttime dosing.
Have an average of at least 2 hours per day "off" time during the waking hours and at least 1 hour "off" time per day, based on the PD diary collected for 3 consecutive days prior to Visit 1.
Exclusion criteria:
Have used first morning dose of controlled-release (CR) CD-LD or Rytary for at least 4 weeks prior to Visit 1.
Female subjects who are currently breastfeeding or lactating.
Had prior functional neurosurgical treatment for PD (ablation or deep brain stimulation) or if such procedure(s) are planned or anticipated during the study period.
Allergic to study drugs
History of medical conditions or of a prior surgical procedure that would interfere with LD absorption, such as gastrectomy or small-bowel resection.
History of peptic ulcer disease or upper gastrointestinal hemorrhage.
History of narrow angle glaucoma.
History of myocardial infarction with residual atrial, nodal, or ventricular arrhythmias; neuroleptic malignant syndrome; or nontraumatic rhabdomyolysis.
History of psychosis.
Employees or family members of the Investigator, study site, or Sponsor.
Subjects who, in the opinion of the clinical investigator, should not participate in the study.
Based on clinical assessment, subject does not adequately comprehend the terminology needed to complete the PD diary.
Sites / Locations
- Muhammad Ali Movement Disorder Center (MAMDC)
- Clinical Trials, Inc.
- The Parkinson's and Movement Disorder Institute
- Parkinson's Disease and Movement Disorders Center of Boca Raton
- Collier Neurologic Specialists
- University of South Florida Parkinson's Disease and Movement Disorder Center
- Georgia Regents University
- QUEST Research Institute
- Duke University Movement Disorders Clinic
- University Hospitals Case Medical Center
- Premier Clinical Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Other
Other
Other
Sequence 1
Sequence 2
Sequence 3
Subject received a single dose of IPX203 180 mg and/or IPX203 270mg in Period 1, a single dose of CD-LD IR in Period 2, and a single dose of Rytary 145 mg and/or Rytary 195 mg in Period 3.
Subject received a single dose of a single dose of CD-LD IR in Period 1, a single dose of Rytary 145 mg and/or Rytary 195 mg in Period 2, and a single dose of IPX203 180 mg and/or IPX203 270mg in Period 3.
Subject received a single dose of a single dose of Rytary 145 mg and/or Rytary 195 mg in Period 1, a single dose of IPX203 180 mg and/or IPX203 270mg in Period 2, and a single dose of CD-LD IR in Period 3.