The purpose of this study is to determine whether the gastric retentive Accordion Pill™ Carbidopa/Levodopa (AP-CD/LD) is more effective than the commercially available immediate release Carbidopa/Levodopa in reducing motor fluctuations such as "off time" in advanced Parkinson's Disease patients.
A multi-center, global, randomized, double-blind, double-dummy, active-controlled, parallel-group study in adult subjects with fluctuating PD. The study will have 2 open label Titration periods of 6 weeks each prior to the double blind Maintenance period. In the open label periods all patients will be stabilized on the active comparator Sinemet® and then on AP-CD/LD. The double blind Maintenance period will be 13 weeks long.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
420
AP-CD/LD capsule containing 50 mg carbidopa with 400 mg or 500 mg levodopa administered orally twice or 3 times a day
Sinemet® tables containing carbidopa and levodopa 25/100 mg will be administered orally at least 4 times a day according to patients need
Placebo for AP-CD/LD capsule
Change from Baseline through study completion, an average of 27 weeks, in the percentage of daily "Off time" during waking hours
Change from Baseline through study completion, an average of 27 weeks, in the percentage of daily "Off time" during waking hours based on Hauser Home Diary assessments; Total number of "Off " hours normalized to a 16- hour waking day will also be calculated but only a single p-value applicable to both the percentage and hours will be reported.
Time frame: Baseline through study completion, an average of 27 weeks
Change from Baseline through study completion, an average of 27 weeks, in "On time" without troublesome dyskinesia during waking hours
Time frame: Baseline through study completion, an average of 27 weeks
Change in the number of total daily LD doses from Baseline through study completion, an average of 27 weeks (hours)
Time frame: Baseline through study completion, an average of 27 weeks
CGI-I through study completion, an average of 27 weeks, as recorded by physician & patient
Time frame: Baseline through through study completion, an average of 27 weeks,
Change from Baseline through study completion, an average of 27 weeks, in total UPDRS Score (Sum of Parts I-III)
Time frame: Baseline through study completion, an average of 27 weeks
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Placebo for Sinemet tables
University Alabama Hospital Neurology
Birmingham, Alabama, United States
Saint Joseph's Hospital and Medical Center Muhammad Ali Parkinson Research Center
Phoenix, Arizona, United States
Parkinson's Disease & Movement Disorders Center, Dept of Neu
Fountain Valley, California, United States
Loma Linda University Medical Center
Loma Linda, California, United States
University of Southern California
Los Angeles, California, United States
SC3 Research
Pasadena, California, United States
SC3 Research
Reseda, California, United States
UC Davis Medical Center
Sacramento, California, United States
University of Colorado Dept. of Neurology
Aurora, Colorado, United States
Hartford HealthCare
Vernon, Connecticut, United States
...and 87 more locations