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

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

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 disease.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: IMPAX Laboratories, Inc.; Impax Laboratories, LLC
• Treatments: Carbidopa; Carbidopa, levodopa drug combination; Levodopa

Criteria

Inclusion Criteria:

1. Male or female diagnosed with idiopathic PD, without any known cause for Parkinsonism.

2. 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.

3. At least 30 years old at the time of diagnosis of PD.

4. Mini Mental State Examination (MMSE) ≥ 26 at Screening Visit.

5. 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.

6. Must have predictable fluctuations between "on" and "off" states.

7. Hoehn and Yahr Stage I-IV when "on".

8. Able to provide informed consent and willing to sign Health Insurance Portability and Accountability Act (HIPAA) authorization.

9. Able and willing to comply with the protocol, including availability for all scheduled study visits and blood sample collections.

Exclusion Criteria:

1. Pregnant or breastfeeding.

2. Diagnosed with atypical parkinsonism.

3. History, physical findings or laboratory results suggesting a diagnosis other than PD.

4. Allergic or nonresponsive to previous CD-LD therapy.

5. 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.

6. Exposure to any investigational agent within 30 days prior to Visit 1.

7. Donated blood or plasma within 28 days.

8. Had prior functional neurosurgical treatment for PD (ablation or Deep Brain Stimulation).