This is a multicenter, randomized, three-arm, parallel-group, double-blind, placebo-controlled, study to evaluate the efficacy, safety and pharmacokinetics (PK) of pridopidine vs. placebo for the treatment of Levodopa Induced Dyskinesia (LID) in patients with Parkinson Disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
23
Oral capsule
Oral capsule
Change From Baseline in Levodopa-induced Dyskinesia as Measured by UDysRS Score
Mean change from baseline (BL) in the sum of Parts 1, 3 and 4 of the Unified Dyskinesia Rating Scale (UdysRS), in the ON state. The UDysRS comprises 2 primary sections i.e. Historical \[Part 1 (ON-Dyskinesia) and Part 2 (OFF-Dystonia)\] and Objective \[Part 3 (Impairment) and Part 4 (Disability)\] assessment. ON-Dyskinesia are choreic and dystonic movements that occur when the Parkinson's disease (PD) medicine is working. Lower UDysRS values mean better patient outcome i.e. less dyskinesia. The UDysRS score for this study is calculated as sum of the parts, with scores of 0-44 for Part 1, 0-28 for Part 3 and 0-16 for Part 4.
Time frame: Baseline; Visit 7 (at Week 16) planned. Since the study was terminated early due to the COVID-19 pandemic, analysis of the primary endpoint was done at Visit 5 (Week 8/10) in those patients who were on study drug at this visit.
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Prilenia Investigational Site (Site 117)
Birmingham, Alabama, United States
Prilenia Investigational Site (Site 144)
Phoenix, Arizona, United States
Prilenia Investigational Site (Site 111)
Phoenix, Arizona, United States
Prilenia Investigational Site (Site 115)
Scottsdale, Arizona, United States
Prilenia Investigational Site (Site 106)
Fountain Valley, California, United States
Prilenia Investigational Site (Site 109)
Irvine, California, United States
Prilenia Investigational Site (Site 105)
Pasadena, California, United States
Prilenia Investigational Site (Stie 142)
Torrance, California, United States
Prilenia Investigational Site (Site 136)
Aurora, Colorado, United States
Prilenia Investigational Site (Site 135)
Englewood, Colorado, United States
...and 23 more locations