The study is a multicenter, randomized, double-blind, double-dummy, active-controlled, Phase III clinical study. The aim of this trial is to evaluated the efficacy and assessed the safety of HRG2010 compared with a sustained-release cabridopa-levodopa formulation in Parkinson's Disease With Motor Fluctuations.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
165
Subjects will receive HRG2010 and Sustained-release Carbidopa/Levodopa administered placebo administered orally.
Subjects will receive Sustained-release Carbidopa/Levodopa and HRG2010 placebo administered orally.
Beijing Hospital
Beijing, Beijing Municipality, China
Change from baseline in "Off" time at Week 21
Time frame: Last three days collected at the end of treatment period, at Week 21
Change from baseline in "On" Time Without Troublesome Dyskinesia at Week 21
Time frame: Last three days collected at the end of treatment period, at Week 21
Change from baseline in the Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) at Week 21
Time frame: Week 21
Change from baseline in the 39-item Parkinson's Disease Questionnaire (PDQ-39) at Week 21
Time frame: Week 21
Adverse events
Time frame: Week 23
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