A Study to Assess the PK and Pharmacodynamics of IPX203 in Patients With Advanced Parkinson's Disease

Completed · Phase 2

Conditions studied: Parkinson's Disease

In brief

This is a randomized, open-label, rater-blinded, multicenter, 3-treatment, 3 period, single-dose crossover study. Approximately 51 qualified immediate-release (IR) CD-LD-experienced advanced Parkinson's disease patients will be randomized to 1 of 3 dosing sequences. Objectives: * Assess the pharmacodynamics and pharmacokinetics (PK) of IPX203 (carbidopa and levodopa) in subjects with advanced Parkinson's disease. * Characterize the safety of IPX203 in subjects with advanced Parkinson's disease.

Key facts

Study ID

NCT02271503

Run by

Impax Laboratories, LLC

People needed

26

Starts

2015-11-01

Expected to finish

2016-08-01

Last updated by the study team

2019-11-06

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Muhammad Ali Movement Disorder Center (MAMDC) — Phoenix, Arizona, United States
• Clinical Trials, Inc. — Little Rock, Arkansas, United States
• The Parkinson's and Movement Disorder Institute — Fountain Valley, California, United States
• Parkinson's Disease and Movement Disorders Center of Boca Raton — Boca Raton, Florida, United States
• Collier Neurologic Specialists — Naples, Florida, United States
• University of South Florida Parkinson's Disease and Movement Disorder Center — Tampa, Florida, United States
• Georgia Regents University — Augusta, Georgia, United States
• QUEST Research Institute — Farmington Hills, Michigan, United States
• Duke University Movement Disorders Clinic — Durham, North Carolina, United States
• University Hospitals Case Medical Center — Cleveland, Ohio, United States
• Premier Clinical Research — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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