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
Tampa, Florida
Principal Investigator: Robert Hauser
2136
mi
from 91732
Tampa, FL
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1000 Alpine
Boulder, Colorado 80304
303-443-7229
812
mi
from 91732
Boulder, CO
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911 E. Hallandale Beach Blvd
Hallandale Beach, Florida 33009
954-455-5757
Principal Investigator: Beth Safirstein
2319
mi
from 91732
Hallandale Beach, FL
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Boca Raton, Florida 33486
Principal Investigator: Stuart Isaacson
2311
mi
from 91732
Boca Raton, FL
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Brandon, Florida 33511
Principal Investigator: Danial Lorch
2146
mi
from 91732
Brandon, FL
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3411 Wayne Avenue
Bronx, New York 10467
Principal Investigator: Renee Monderer
2438
mi
from 91732
Bronx, NY
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232 South Woods Mill Road
Chesterfield, Missouri 63017
Principal Investigator: Paula Schweitzer
1556
mi
from 91732
Chesterfield, MO
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Chevy Chase, Maryland 20815
Principal Investigator: Helene Emsellem
2278
mi
from 91732
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...
1726
mi
from 91732
Chicago, IL
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Columbia, South Carolina 29201
Principal Investigator: Richard Bogan
2105
mi
from 91732
Columbia, SC
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Englewood, Colorado 80113
Principal Investigator: Rajeev Kumar
816
mi
from 91732
Englewood, CO
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Farmington Hills, Michigan 48334
1952
mi
from 91732
Farmington Hills, MI
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Kansas City, Kansas
Principal Investigator: Rajesh Pahwa
1339
mi
from 91732
Kansas City, KS
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Kirkland, Washington 98034
Principal Investigator: Alida Griffith
967
mi
from 91732
Kirkland, WA
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Los Angeles, California 90048
Principal Investigator: Roy Artal
13
mi
from 91732
Los Angeles, CA
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Miami, Florida 33143
Principal Investigator: Timothy Grant
2318
mi
from 91732
Miami, FL
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Nashville, Tennessee 37232
?
mi
from 91732
Nashville, TN
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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...
1164
mi
from 91732
Oklahoma City, OK
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100 West Gore Street
Orlando, Florida 32806
Principal Investigator: George Stoica
2184
mi
from 91732
Orlando, FL
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Philadelphia, Pennsylvania 19107
Principal Investigator: Jay Schneider
2375
mi
from 91732
Philadelphia, PA
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2337 South Clinton Avenue
Rochester, New York 14618
Principal Investigator: Michael Yurcheshen
2246
mi
from 91732
Rochester, NY
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San Diego, California 92103
Principal Investigator: Stephen Thein
103
mi
from 91732
San Diego, CA
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324 South Sherman Street
Spokane, Washington 99202
Principal Investigator: Jason Aldred
938
mi
from 91732
Spokane, WA
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Sterling Heights, Michigan 48314
Principal Investigator: Rahul Sangal
1970
mi
from 91732
Sterling Heights, MI
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West Bloomfield, Michigan 48322
Principal Investigator: Peter LeWitt
1951
mi
from 91732
West Bloomfield, MI
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