This study is a 4-week, multicenter, randomized, double-blind, placebo-controlled, ascending dose, 4-period crossover study designed to evaluate the safety, tolerability, efficacy, and PK of JZP-110 (75, 150, and 300 mg) in the treatment of excessive sleepiness in adult subjects with idiopathic PD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
66
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Early Discontinuation
Time frame: Up to Day 35
Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score
Change from Baseline ESS defined in terms of change from study baseline (prior to first dose in Period 1) to the end of each Treatment Period (Weeks 1, 2, 3, and 4). The Epworth Sleepiness Scale (ESS) is a self-administered questionnaire with 8 questions, asking subjects how likely they would be to doze off or fall asleep in different situations. Responses range from 0 = would never doze to 3 = high chance of dozing. Higher scores represent greater severity of excessive sleepiness. The total score ranges from 0 - 24, with higher scores representing greater severity of excessive sleepiness.
Time frame: Baseline to Weeks 1, 2, 3, and 4
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Southern California Institute For Respiratory Diseases, Inc.
Los Angeles, California, United States
Pacific Research Network, Inc
San Diego, California, United States
Alpine Clinical Research Center
Boulder, Colorado, United States
Rocky Mountain Movement Disorders Center, PC
Englewood, Colorado, United States
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, United States
PAB Clinical Research
Brandon, Florida, United States
MD Clinical
Hallandale, Florida, United States
QPS MRA (Miami Research Associates)
Miami, Florida, United States
Bioclinica Research
Orlando, Florida, United States
USF Health Byrd Institute
Tampa, Florida, United States
...and 15 more locations