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



Status:Completed
Conditions:Parkinsons Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:35 - 80
Updated:8/31/2018
Start Date:January 2017
End Date:August 2018

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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

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.


Inclusion Criteria:

1. Diagnosis of idiopathic PD according to the UK PDS Brain Bank Criteria.

2. Hoehn and Yahr stage 1, 2, or 3.

3. Screening and Baseline ESS scores >11.

Exclusion Criteria:

1. Diagnosis of other degenerative Parkinsonian syndromes (e.g., progressive supranuclear
palsy, multiple system atrophy [MSA], or dementia with Lewy bodies [DLB]).

2. Usual nightly time in bed of <6 hours, including the night before the Baseline visit.

3. Untreated or inadequately treated moderate to severe OSA.

4. 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.
We found this trial at
25
sites
Nashville, Tennessee 37232
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1000 Alpine
Boulder, Colorado 80304
303-443-7229
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911 E. Hallandale Beach Blvd
Hallandale Beach, Florida 33009
954-455-5757
Principal Investigator: Beth Safirstein
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Hallandale Beach, FL
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Boca Raton, Florida 33486
Principal Investigator: Stuart Isaacson
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Boca Raton, FL
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Brandon, Florida 33511
Principal Investigator: Danial Lorch
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Brandon, FL
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3411 Wayne Avenue
Bronx, New York 10467
Principal Investigator: Renee Monderer
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Bronx, NY
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232 South Woods Mill Road
Chesterfield, Missouri 63017
Principal Investigator: Paula Schweitzer
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Chesterfield, MO
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Chevy Chase, Maryland 20815
Principal Investigator: Helene Emsellem
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Chevy Chase, MD
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Chicago, IL
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Columbia, South Carolina 29201
Principal Investigator: Richard Bogan
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Columbia, SC
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Englewood, Colorado 80113
Principal Investigator: Rajeev Kumar
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Englewood, CO
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Farmington Hills, Michigan 48334
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Farmington Hills, MI
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Kansas City, Kansas
Principal Investigator: Rajesh Pahwa
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Kansas City, KS
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Kirkland, Washington 98034
Principal Investigator: Alida Griffith
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Kirkland, WA
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Los Angeles, California 90048
Principal Investigator: Roy Artal
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Los Angeles, CA
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Miami, Florida 33143
Principal Investigator: Timothy Grant
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Miami, FL
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3555 NW 58th St # 800
Oklahoma City, Oklahoma 73112
(405) 447-8839
Principal Investigator: Carl Griffin
Lynn Health Science Institute Our mission is to provide clinical trials research and health services...
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Oklahoma City, OK
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100 West Gore Street
Orlando, Florida 32806
Principal Investigator: George Stoica
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Orlando, FL
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Philadelphia, Pennsylvania 19107
Principal Investigator: Jay Schneider
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Philadelphia, PA
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2337 South Clinton Avenue
Rochester, New York 14618
Principal Investigator: Michael Yurcheshen
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Rochester, NY
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San Diego, California 92103
Principal Investigator: Stephen Thein
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San Diego, CA
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324 South Sherman Street
Spokane, Washington 99202
Principal Investigator: Jason Aldred
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Spokane, WA
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Sterling Heights, Michigan 48314
Principal Investigator: Rahul Sangal
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Sterling Heights, MI
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Tampa, Florida
Principal Investigator: Robert Hauser
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Tampa, FL
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West Bloomfield, Michigan 48322
Principal Investigator: Peter LeWitt
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West Bloomfield, MI
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