The primary objective of this study is to explore the efficacy and tolerability of DM-1992 compared to a standard carbidopa/Levodopa Immediate-Release (CD/LD IR) tablet (Sinemet IR) as measured by: * "ON" time with no dyskinesia or non-troublesome dyskinesia * "OFF" time
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
34
72.5mg carbidopa/230mg levodopa
Immediate-release tablet containing 25mg carbidopa and 100mg levodopa
Unnamed facility
Birmingham, Alabama, United States
Unnamed facility
Little Rock, Arkansas, United States
Unnamed facility
Long Beach, California, United States
Unnamed facility
Chicago, Illinois, United States
The Primary Objective of This Study is to Explore the Efficacy and Tolerability of DM-1992 Compared to a Standard CD/LD IR Formulation as Measured by Percent "OFF" Time.
"OFF" indicates wearing off motor fluctuations before the next levodopa dose. Percent "OFF" time is calculated as the total "OFF" time divided by the total awake time for each day and multiplied by 100. Patient diary-every 30min while awake for 3days prior to initial Day1 as baseline \& during the last 3days before Day10 for both treatments for dyskinesia state. Baseline is the average of the 3 days recorded in the patient diary prior to Day 1 of Period 1. End of Period is the average of the 3 days recorded in the patient diary prior to Day 10 in each period. Clinician-Assess efficacy at pre-dose, every 30min for Day1 and hourly for Day10 for dyskinesia state \& motor fluctuations at clinic visits.
Time frame: Baseline and 10 days for each of the 2 study periods
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Unnamed facility
Bingham Farms, Michigan, United States
Unnamed facility
Cincinnati, Ohio, United States
Unnamed facility
Dallas, Texas, United States