An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects With Parkinson’s Disease

Brief Summary

Official Title: “An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects With Parkinson’s Disease”

The purpose of this study is to determine the long term safety and clinical utility of IPX066 in subjects with Parkinson's Disease.

  • Study Type: Interventional
  • Study Design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: October 2011

Detailed Clinical Trial Description

IPX066 is intended for chronic treatment of motor symptoms for all stages of PD. This study is designed to enroll subjects who have successfully completed one of the following studies of IPX066:

- IPX066-B08-05 (A Placebo-Controlled Study to Evaluate the Safety and Efficacy of IPX066 in Subjects with Parkinson's Disease)

- IPX066-B08-11 (A Study to Compare Pharmacokinetics and Pharmacodynamics of IPX066 to Standard Carbidopa – Levodopa)

- IPX066-B09-02 (A Study to Evaluate the Safety and Efficacy of IPX066 in Advanced Parkinson's Disease)

All participants will be given IPX066 for 9 months.

Interventions Used in this Clinical Trial

  • Drug: IPX066
    • IPX066

Arms, Groups and Cohorts in this Clinical Trial

  • Other: Open Label IPX066
    • IPX066

Outcome Measures for this Clinical Trial

Primary Measures

  • Unified Parkinson’s Disease Rating Scale (UPDRS), parts I-IV
    • Time Frame: 9 months
      Safety Issue?: No

Secondary Measures

  • Parkinson’s Disease Questionnaire-39 (PDQ-39)
    • Time Frame: 9 months
      Safety Issue?: No
  • Patient Global Impression (PGI)
    • Time Frame: 9 months
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria

  • Each subject must meet the following inclusion criteria in order to be enrolled in the study:

1. Successful completion of studies IPX066-B08-05, IPX066-B08-11, or IPX066-B09-02.

2. In the opinion of the Investigator, the Parkinson's disease diagnosis is still valid and the subject remains eligible for LD therapy.

Exclusion Criteria

  • Each subject must be free of the following exclusion criteria in order to be enrolled in the study:

1. Received an investigational medication other than those from an IPX066 trial within 4 weeks prior to the planned start of treatment.

2. Anticipates functional neurosurgical treatment for PD (e.g., ablation or deep brain stimulation) during study participation.

3. Received within 4 weeks prior to Baseline Visit or planning to take during study participation: nonselective monoamine oxidase (MAO) inhibitors (with the exception of rasagiline).

4. In the opinion of the Investigator, should not participate in the study.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 30 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • IMPAX Laboratories, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • IPX066-B09-03 Impax Study Director, Study Director, Impax Pharmaceuticals, a division of Impax Laboratories

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01096186