This is a study to compare the efficacy of IPX066 and CLE in subjects with advanced Parkinson's disease.
This is a randomized, double-blind, double-dummy, 2 treatment, 2-period crossover study followed by an open-label extension study period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
110
Margolin Brain Institute
Fresno, California, United States
Percentage of "OFF" Time During Waking Hours
Using a Parkinson's disease diary, subjects recorded a state of "asleep", "OFF", "ON without dyskinesia," "ON with non-troublesome dyskinesia," or "ON with troublesome dyskinesia" every 30 minutes over a 24-hour day for the last 3 days of each double-blind crossover treatment period. Mean percentage of "OFF" Time During Waking Hours was calculated. "Off" Time is Time when medication has worn off and is no longer providing benefit with regard to mobility, slowness, and stiffness.
Time frame: 3 days of data immediately prior to the end of each 2 week treatment period
Total "OFF" Time During Waking Hours
Using a Parkinson's disease diary, subjects recorded a state of "asleep", "OFF", "ON without dyskinesia," "ON with non-troublesome dyskinesia," or "ON with troublesome dyskinesia" every 30 minutes over a 24-hour day for the last 3 days of each double-blind crossover treatment period. Mean Total "Off" Time During Waking Hours was calculated. "Off" Time is Time when medication has worn off and is no longer providing benefit with regard to mobility, slowness, and stiffness.
Time frame: 3 days of data immediately prior to the end of each 2 week treatment period
Total "On" With No Troublesome Dyskinesia
Using a Parkinson's disease diary, subjects recorded a state of "asleep", "OFF", "ON without dyskinesia," "ON with non-troublesome dyskinesia," or "ON with troublesome dyskinesia" every 30 minutes over a 24-hour day for the last 3 days of each double-blind crossover treatment period. Mean Total "On" with No Troublesome Dyskinesia was calculated. "On" Time is when medication is providing benefit with regard to mobility, slowness, and stiffness.
Time frame: 3 days of data immediately prior to the end of each 2 week treatment period
UPDRS Part II Plus Part III
Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living) and Part III (Motor Examination). Part II consists of 14 questions, each ranges from 0 (Normal/None) - 4 (Worst) with a total score of 0 - 72. Part III consists of 27 questions, each ranges from 0 (Normal/None) - 4 (Worst) with a total score of 0 - 108. The UPDRS Part II Plus Part III scores ranged from 0 (no problems with daily living or mobility) to 180 (severe problems with daily living and mobility.
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The Parkinson's Institute in Sunnyvale
Sunnyvale, California, United States
UM Movement Disorders Center
Miami, Florida, United States
Charlotte Neurological Services
Port Charlotte, Florida, United States
USF Parkinson's and Movement Disorders Center
Tampa, Florida, United States
Quest Research Institute
Bingham Farms, Michigan, United States
University Health Systems
Las Vegas, Nevada, United States
Parkinson's Disease and Movement Disorders Center of Long Island
Commack, New York, United States
Kingston Neurological Associates
Kingston, New York, United States
University Neurology, Inc
Cincinnati, Ohio, United States
...and 14 more locations
Time frame: End of each double-blind treatment period.
Subject Preference
Subjects who completed both treatments were asked to indicate a preference for Treatment Period 1 or Treatment Period 2 or no preference. Preferences for a particular treatment period were mapped to the associated treatment and reported.
Time frame: End of Study (week 11)