The purpose of this study is to allow evaluation of long-term clinical effect and safety outcome of treatment with AP-CD/LD, as well as to allow patients to benefit from extended treatment duration with AP-CD/LD after they have successfully completed the Phase 3 core study IN 11 004 ('core study', a phase III, multicenter, randomized, double-blind, double-dummy, active-controlled Phase 3 study to assess the safety and efficacy of AP CD/LD versus IR CD/LD in fluctuating PD patients).
This will be a multi-center, global, open-label study in adult suffering from fluctuating Parkinson's disease subjects who have successfully completed the core study IN 11 004. After signing informed consent and meeting inclusion/exclusion criteria, eligible subjects will be enrolled into a 12-month open-label extension and receive the AP-CD/LD as needed. Efficacy and safety will be assessed throughout the study period.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
460
Accordion Pill™ Carbidopa/Levodopa Capsule 50/400mg , b.i.d or t.i.d or Accordion Pill™ Carbidopa/Levodopa Capsule 50/500mg , b.i.d or t.i.d
Unified Parkinson's Disease Rating Scale (UPDRS)
Change from Baseline to End of Study (Week 53) in Parts I-IV
Time frame: base line ( week 1) to end of study ( week 53)
Safety (Adverse Events, Safety laboratory, Vital signs)
Adverse Events, Safety laboratory, Vital signs
Time frame: One Year
Change in Parkinson's disease Questionnaire - 39 items (PDQ39).
Change from baseline to End of Study in Parkinson's disease Questionnaire - 39 items (PDQ39).
Time frame: Base line to end of study ( week 53)
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University Alabama Hospital Neurology
Birmingham, Alabama, United States
RECRUITINGSaint Joseph's Hospital and Medical Center Muhammad Ali Parkinson Research Center
Phoenix, Arizona, United States
NOT_YET_RECRUITINGBanner Sun Health Research Institute
Sun City, Arizona, United States
TERMINATEDParkinson's Disease & Movement Disorders Center
Fountain Valley, California, United States
NOT_YET_RECRUITINGLoma Linda University Medical Center
Loma Linda, California, United States
NOT_YET_RECRUITINGUniversity of Southern California
Los Angeles, California, United States
NOT_YET_RECRUITINGSC3 Research
Pasadena, California, United States
NOT_YET_RECRUITINGSC3 Research
Reseda, California, United States
NOT_YET_RECRUITINGUniversity of Colorado Dept. of Neurology
Aurora, Colorado, United States
RECRUITINGHartford HealthCare
Vernon, Connecticut, United States
RECRUITING...and 75 more locations