Carbidopa-Levodopa (CD-LD) ER Alone or in Combination With CD-LD IR to IPX066 Followed by IPX066 Extension Safety Study
Status:
Completed
Trial end date:
2013-03-01
Target enrollment:
Participant gender:
Summary
The study had three distinct parts and is described as follows:
Part 1:
- To evaluate the dose conversion from CD-LD ER taken alone or in combination with CD-LD
IR to IPX066 in subjects with advanced PD
- To evaluate the utility of the Objective Parkinson's Disease Measurement (OPDM), an
exploratory computer-based system, in assessing dexterity and mobility in a subset of PD
subjects.
Part 2:
• To evaluate the long-term safety and clinical utility of IPX066 under open-label conditions
in eligible subjects who successfully completed Part 1 of the study.
Part 3:
• To further evaluate the long-term safety of IPX066 in eligible subjects who successfully
completed Part 2.
Phase:
Phase 3
Details
Lead Sponsor:
IMPAX Laboratories, Inc. Impax Laboratories, LLC
Collaborator:
Michael J. Fox Foundation for Parkinson's Research
Treatments:
Carbidopa Carbidopa, levodopa drug combination Levodopa