A 4-Week, Double-blind, Placebo-controlled, Randomized, Multicenter, Crossover Study of the Safety, Efficacy, and Pharmacokinetics of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate Hydrochloride] in Subjects With Parkinson's Disease and Excessive Sleepiness
Status: Completed
Location: See all (25) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 35
Maximum Age: 80
Healthy Volunteers: f
View:
• Diagnosis of idiopathic PD according to the UK PDS Brain Bank Criteria.
• Hoehn and Yahr stage 1, 2, or 3.
• Screening and Baseline ESS scores \>11.
Locations
United States
California
Southern California Institute For Respiratory Diseases, Inc.
Los Angeles
Pacific Research Network, Inc
San Diego
Colorado
Alpine Clinical Research Center
Boulder
Rocky Mountain Movement Disorders Center, PC
Englewood
Florida
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton
PAB Clinical Research
Brandon
MD Clinical
Hallandale Beach
QPS MRA (Miami Research Associates)
Miami
Bioclinica Research
Orlando
USF Health Byrd Institute
Tampa
Illinois
Rush University Medical Center
Chicago
Kansas
University of Kansas Medical Center Research Institute, Inc.
Kansas City
Maryland
Center for Sleep & Wake Disorders
Chevy Chase
Michigan
QUEST Research Institute
Farmington Hills
Clinical Neurophysiology Services, P.C.
Sterling Heights
Henry Ford Medical Center - West Bloomfield
West Bloomfield
Missouri
St. Lukes Hospital Medical Center
Chesterfield
New York
Montefiore Sleep-Wake Disorders Center
Bronx
Strong Sleep Disorders Center
Rochester
Oklahoma
Lynn Health Science Institute
Oklahoma City
Pennsylvania
Parkinson's Disease Research Unit - Thomas Jefferson University
Philadelphia
South Carolina
SleepMed of South Carolina
Columbia
Tennessee
Villages at Vanderbilt
Nashville
Washington
Evergreen Hospital Medical Center
Kirkland
Premier Clinical Research - Sherman
Spokane
Time Frame
Start Date: 2017-01
Completion Date: 2018-08
Participants
Target number of participants: 66
Treatments
Experimental: Arm A
JZP-110 and Placebo
Experimental: Arm B
JZP-110 and Placebo
Placebo_comparator: Arm C
Placebo
Authors
Related Therapeutic Areas
Sponsors
Leads: Jazz Pharmaceuticals