Carbidopa-Levodopa (CD-LD) ER Alone or in Combination With CD-LD IR to IPX066 Followed by IPX066 Extension Safety Study
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|ClinicalTrials.gov Identifier: NCT01411137|
Recruitment Status : Completed
First Posted : August 8, 2011
Results First Posted : April 18, 2017
Last Update Posted : May 22, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease||Drug: IPX066||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||43 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||August 2011|
|Primary Completion Date :||March 2013|
|Study Completion Date :||March 2013|
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
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.|