Carbidopa-Levodopa (CD-LD) ER Alone or in Combination With CD-LD IR to IPX066 Followed by IPX066 Extension Safety Study
The study had three distinct parts and is described as follows:
- 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.
• 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.
• To further evaluate the long-term safety of IPX066 in eligible subjects who successfully completed Part 2.
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||An Open Label Conversion Study of Carbidopa-Levodopa (CD-LD) Extended-Release Taken Alone or in Combination With CD-LD Immediate Release to IPX066 Followed by an Open-Label Extension Safety Study of IPX066 in Advanced PD|
- Patient Global Impression (PGI) [ Time Frame: 6 months ]At Part 1 Week 6, Part 2 Month 3 and Month 6 or at Early Termination, the subjects rated the change in their condition with IPX066 treatment from their condition prior to Part 1 Visit 1(Baseline) using Patient Global Impression (PGI) 7-point scale. 1=very much worse and 7=very much improved.
- Clinical Global Impression (CGI) [ Time Frame: 6 months ]
Clinician-reported satisfaction outcome of IPX066 using Clinical Global Impression (PGI) 7-point scale.
At Part 1 Week 6; Part 2 Month 3, and Month 6 or at Early Termination, the Investigator rated how much a subject's overall condition had changed since Part 1 Visit 1 (Baseline) using 7-point scale. 1=very much worse and 7=very much improved.
- Parkinson's Disease Questionnaire-8 (PDQ-8) [ Time Frame: 6 months ]Change from Baseline in Parkinson's disease Questionnaire-8 (PDQ-8) at End of Study or early discontinuation. The PDQ-8 is a self-reported questionnaire consisting of 8 questions regarding the subject's disease symptoms, each item ranging from 0 to 4, and the responses consist of 0=Never, 1=Occasionally, 2=Sometimes, 3=Often, and 4=Always or cannot do at all, total score ranging from 0 (never have problems/issues) to 32 (always have problems or cannot do at all).
|Study Start Date:||August 2011|
|Study Completion Date:||March 2013|
|Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
Subjects were to receive individualized IPX066 doses orally in an open-label manner using four dosage strengths.
Subjects were converted from their current treatment to IPX066 over a 6-week period.
Experimental Drug Product: IPX066 (carbidopa-levodopa) extended-release capsules
Other Name: ER CD-LD
Part 1: This study was a multicenter, open-label study. Subjects were to be converted from their previous CD-LD treatment to IPX066 over a 6-week period. Up to 40 subjects were to be enrolled in the study. Enrollment was defined as subjects who received study drug in Part 1 - Visit 1. Subjects were to be entered into one of two cohorts.
Approximately 24 subjects were to enroll in Cohort 1 (non-OPDM subjects) and up to 16 subjects at selected sites were to enroll in Cohort 2 (OPDM subjects). For the subjects enrolled in Cohort 2, along with the OPDM measurements, PK blood samples were also to be collected.
Part 2: Following the successful completion of Part 1 of the study, eligible subjects could participate in Part 2, a 6-month open-label extension study.
Part 3: Following the successful completion of Part 2 of the study, eligible subjects could participate in Part 3, an additional 6-month open-label extension study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01411137
|United States, Alabama|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35233|
|United States, California|
|Coastal Neurological Medical Group|
|La Jolla, California, United States, 92037|
|The Parkinson's Institute|
|Sunnyvale, California, United States, 94085|
|United States, Florida|
|Renstar Medical Research|
|Ocala, Florida, United States, 34471|
|United States, Michigan|
|Quest Research Institute|
|Bingham Farms, Michigan, United States, 48025|
|United States, Nevada|
|University of Nevada School of Medicine|
|Las Vegas, Nevada, United States, 89102|
|United States, New York|
|Parkinson's Disease and Movement Disorders Center of Long Island|
|Commack, New York, United States, 11725|
|United States, Wisconsin|
|Wisconsin Institute for Neurologic and Sleep Disorders|
|Milwaukee, Wisconsin, United States, 53233|
|Study Chair:||Impax Study Director||Impax Pharmaceuticals Division (Impax) , a Division of Impax Laboratories Inc.|