A Study to Compare Pharmacokinetics and Pharmacodynamics of IPX066 to Standard Carbidopa-Levodopa

Completed · Phase 2

Conditions studied: Parkinson's Disease

In brief

This study evaluated the pharmacokinetics, motor effects, and assessed the safety of IPX066 compared with an immediate-release cabridopa-levodopa formulation in subjects with advanced Parkinson's disease.

Key facts

Study ID

NCT00869791

Run by

Impax Laboratories, LLC

People needed

27

Starts

2008-11-01

Expected to finish

2009-06-01

Last updated by the study team

2019-11-08

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female diagnosed with idiopathic PD, without any known cause for Parkinsonism.
• If female and of childbearing potential, subject should be abstinent or continuing to practice and willing to continue throughout the study with appropriate contraceptives (defined as Nova ring, oral, injected, transdermal patch, implanted, or barrier). The subject must agree to take every precaution to ensure that pregnancy will not occur during the study.
• At least 30 years old at the time of diagnosis of PD.
• Mini Mental State Examination (MMSE) ≥ 26 at Screening Visit.
• A responder to LD and currently being chronically treated with stable dosage of commercially available standard, orally disintegrating, or controlled-release CD LD for at least 1 month.
• Must have predictable fluctuations between "on" and "off" states.
• Hoehn and Yahr Stage I-IV when "on".
• Able to provide informed consent and willing to sign Health Insurance Portability and Accountability Act (HIPAA) authorization.
• Able and willing to comply with the protocol, including availability for all scheduled study visits and blood sample collections.

You may not qualify if…

• Pregnant or breastfeeding.
• Diagnosed with atypical parkinsonism.
• History, physical findings or laboratory results suggesting a diagnosis other than PD.
• Allergic or nonresponsive to previous CD-LD therapy.
• Any medical (e.g., liver or kidney impairment, peptic ulcer) or condition/history that, in the Investigator's opinion, may jeopardize the subject's safety.
• Exposure to any investigational agent within 30 days prior to Visit 1.
• Donated blood or plasma within 28 days.
• Had prior functional neurosurgical treatment for PD (ablation or Deep Brain Stimulation).

Where it is running

• IMPAX Laboratories — Hayward, California, United States

Full record on ClinicalTrials.gov

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