A 4-Week 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

Completed · Phase 2 · Has a placebo group

Conditions studied: Excessive Sleepiness, Parkinson Disease

In brief

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.

Key facts

Study ID

NCT03037203

Run by

Jazz Pharmaceuticals

People needed

66

Starts

2017-01-01

Expected to finish

2018-08-01

Last updated by the study team

2020-01-09

Who can join

Age: 35 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Diagnosis of other degenerative Parkinsonian syndromes (e.g., progressive supranuclear palsy, multiple system atrophy [MSA], or dementia with Lewy bodies [DLB]).
• Usual nightly time in bed of <6 hours, including the night before the Baseline visit.
• Untreated or inadequately treated moderate to severe OSA.
• Has evidence at screening of severe cognitive impairment or has cognitive impairment that in the opinion of the investigator would prevent completion of study procedures or the ability to provide informed consent.

Where it is running

• 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
• Rush University Medical Center — Chicago, Illinois, United States
• University of Kansas Medical Center Research Institute, Inc. — Kansas City, Kansas, United States
• Center for Sleep & Wake Disorders — Chevy Chase, Maryland, United States
• QUEST Research Institute — Farmington Hills, Michigan, United States
• Clinical Neurophysiology Services, P.C. — Sterling Heights, Michigan, United States
• Henry Ford Medical Center - West Bloomfield — West Bloomfield, Michigan, United States
• St. Lukes Hospital Medical Center — Chesterfield, Missouri, United States
• Strong Sleep Disorders Center — Rochester, New York, United States
• Montefiore Sleep-Wake Disorders Center — The Bronx, New York, United States
• Lynn Health Science Institute — Oklahoma City, Oklahoma, United States
• Parkinson's Disease Research Unit - Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• SleepMed of South Carolina — Columbia, South Carolina, United States
• Villages at Vanderbilt — Nashville, Tennessee, United States
• Evergreen Hospital Medical Center — Kirkland, Washington, United States
• Premier Clinical Research - Sherman — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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