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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 | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

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

NCT03037203•Jazz Pharmaceuticals

View on ClinicalTrials.gov

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

Age

35 - 80 years

Sex

ALL

Healthy Volunteers

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.

Locations (25)

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

Key Dates

Start Date

January 1, 2017

Primary Completion Date

August 1, 2018

Completion Date

August 1, 2018

Last Updated

January 9, 2020

Enrollment

ACTUAL participants

Conditions

Excessive SleepinessParkinson Disease

Interventions

JZP-110

DRUG

Placebo

OTHER

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Parkinson Disease

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 9, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

Characterizing the Pathophysiological Role of the Pallido-thalamocortical Motor Pathway in Parkinson's Disease.

[18F]F-DOPA Imaging in Patients With Autonomic Failure

Montelukast in Parkinson Disease

Exercise for Cognitive Excellence in Parkinson's Disease

The Effect of Functional Rotational Exercises on Fall Risk and Mobility in Parkinson's Disease Patients

SAD Study in Patients With Parkinson's Disease and Motor Fluctuations