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

• Status: Completed
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

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.