NCT01096186

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 617 (actual)
• Sponsor: Impax Laboratories, LLC · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
DRUG	IPX066 95 mg	23.75 - 95 mg CD-LD capsules
DRUG	IPX066 145 mg	36.25 - 145 mg CD-LD capsules
DRUG	IPX066 195 mg	48.75 - 195 mg CD-LD capsules
DRUG	IPX066 245 mg	61.25 - 245 mg CD-LD capsules

Timeline

• Start date: 2010-03-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2010-03-31
• Last updated: 2019-11-08
• Results posted: 2016-03-03

Locations

81 sites across 10 countries: United States, Canada, Estonia, Germany, Latvia, Lithuania, Poland, Romania, Spain, Ukraine