A Study to Assess the PK and Pharmacodynamics of IPX203 in Subjects With Advanced Parkinson's Disease
Completed · Phase 2
Conditions studied: Advanced Parkinson's Disease
In brief
Primary Objective: To compare the pharmacokinetics (PK) of single and multiple doses of IPX203 with Immediate release carbidopa-levodopa (IR CD-LD) in subjects with advanced Parkinson's disease (PD). Secondary Objectives: To compare the pharmacodynamics of single and multiple doses of IPX203 with IR CD-LD. To compare the efficacy of IPX203 with IR CD-LD following multiple doses. To evaluate the safety of IPX203.
Key facts
- Study ID
- NCT03007888
- Run by
- Impax Laboratories, LLC
- People needed
- 28
- Starts
- 2016-11-14
- Expected to finish
- 2017-08-01
- Last updated by the study team
- 2022-06-06
Who can join
Age: 40 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosed with idiopathic PD at age ≥ 40 years who are being chronically treated with stable regimens of CD-LD but experiencing motor complications.
- Hoehn and Yahr Stages 2, 3, or 4
- Montreal Cognitive Assessment (MoCA) score ≥ 24 at Screening Visit in "on" state.
- For the 4 weeks prior to the Screening, the subject experiences daily "wearing-off" episodes with periods of bradykinesia and rigidity and experiences an "off" state upon awakening on most mornings by history.
- Responsive to CD-LD therapy and currently being treated on a stable regimen with CD-LD for at least 4 weeks prior to Visit 1
- Typically experiences an "on" response with the first dose of IR CD-LD of the day (by subject history).
- By history, efficacy of the first morning dose of IR CD-LD lasts less than 4 hours
You may not qualify if…
- History of medical conditions or of a prior surgical procedure that would interfere with LD absorption, such as gastrectomy or proximal small-bowel resection.
- Liver enzyme values ≥ 2.5 x the upper limit of normal; or history of severe hepatic impairment.
- History of drug or alcohol abuse within the 12 months prior to Screening.
- Received within 4 weeks of Visit 1 or planning to take during participation in the clinical study: any doses of a controlled-release (CR) LD apart from a single daily bedtime dose or any doses of Rytary, additional CD (eg, Lodosyn) or benserazide (eg, Serazide), or catechol-O-methyl transferase inhibitors (entacapone or tolcapone) or medications containing these inhibitors (Stalevo). Received within 4 weeks of Visit 1 or planning to take during participation in the clinical study: nonselective monoamine oxidase (MAO) inhibitors, apomorphine, or dopaminergic blocking agents including antiemetics.
- History of psychosis within the past 10 years.
- Treatment with any dopamine antagonist antipsychotics for the purposes of psychosis or bipolar disorder within the last 2 years.
- Based on clinical assessment, subject does not adequately comprehend the terminology needed to complete the PD Diary.
Where it is running
- Investigator 110 — Little Rock, Arkansas, United States
- Site 114 — Little Rock, Arkansas, United States
- Investigator 106 — Boca Raton, Florida, United States
- Investigator 112 — Naples, Florida, United States
- Investigator 113 — Port Charlotte, Florida, United States
- Site 108 — Tampa, Florida, United States
- Investigator 101 — Farmington Hills, Michigan, United States
- Site 103 — Durham, North Carolina, United States
- Investigator 109 — Cleveland, Ohio, United States
- Site 115 — Kirkland, Washington, United States
- Investigator 104 — Spokane, Washington, United States
Full record on ClinicalTrials.gov
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