Status:
COMPLETED
A Study to Compare Pharmacokinetics and Pharmacodynamics of IPX066 to Standard Carbidopa-Levodopa
Lead Sponsor:
Impax Laboratories, LLC
Conditions:
Parkinson's Disease
Eligibility:
All Genders
30+ years
Phase:
PHASE2
Brief Summary
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 dise...
Detailed Description
This was a randomized, multicenter, open-label, single and multiple oral dose, two-treatment, two-period, crossover study in LD-experienced subjects with Parkinson's disease (PD). Subjects received 7 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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).
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00869791
Start Date
November 1 2008
End Date
June 1 2009
Last Update
November 8 2019
Active Locations (1)
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1
IMPAX Laboratories
Hayward, California, United States, 94544