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

January 3, 2020 updated by: Jazz Pharmaceuticals

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Southern California Institute For Respiratory Diseases, Inc.
      • San Diego, California, United States, 92103
        • Pacific Research Network, Inc
    • Colorado
      • Boulder, Colorado, United States, 80301
        • Alpine Clinical Research Center
      • Englewood, Colorado, United States, 80113
        • Rocky Mountain Movement Disorders Center, PC
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Parkinson's Disease and Movement Disorders Center of Boca Raton
      • Brandon, Florida, United States, 33511
        • PAB Clinical Research
      • Hallandale Beach, Florida, United States, 33009
        • MD Clinical
      • Miami, Florida, United States, 33143
        • QPS MRA (Miami Research Associates)
      • Orlando, Florida, United States, 32806
        • Bioclinica Research
      • Tampa, Florida, United States, 33613
        • USF Health Byrd Institute
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center Research Institute, Inc.
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • Center for Sleep & Wake Disorders
    • Michigan
      • Farmington Hills, Michigan, United States, 48334
        • Quest Research Institute
      • Sterling Heights, Michigan, United States, 48314
        • Clinical Neurophysiology Services, P.C.
      • West Bloomfield, Michigan, United States, 48322
        • Henry Ford Medical Center - West Bloomfield
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • St. Lukes Hospital Medical Center
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Sleep-Wake Disorders Center
      • Rochester, New York, United States, 14618
        • Strong Sleep Disorders Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Lynn Health Science Institute
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Parkinson's Disease Research Unit - Thomas Jefferson University
    • South Carolina
      • Columbia, South Carolina, United States, 29201
        • SleepMed of South Carolina
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Villages at Vanderbilt
    • Washington
      • Kirkland, Washington, United States, 98034
        • Evergreen Hospital Medical Center
      • Spokane, Washington, United States, 99202
        • Premier Clinical Research - Sherman

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A
JZP-110 and Placebo
Other: Placebo
Drug: JZP-110
75 mg, 150 mg, 300 mg
Experimental: Arm B
JZP-110 and Placebo
Other: Placebo
Drug: JZP-110
75 mg, 150 mg, 300 mg
Placebo Comparator: Arm C
Placebo
Other: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Early Discontinuation
Time Frame: Up to Day 35
Up to Day 35

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score
Time Frame: Baseline to Weeks 1, 2, 3, and 4

Change from Baseline ESS defined in terms of change from study baseline (prior to first dose in Period 1) to the end of each Treatment Period (Weeks 1, 2, 3, and 4).

The Epworth Sleepiness Scale (ESS) is a self-administered questionnaire with 8 questions, asking subjects how likely they would be to doze off or fall asleep in different situations. Responses range from 0 = would never doze to 3 = high chance of dozing. Higher scores represent greater severity of excessive sleepiness. The total score ranges from 0 - 24, with higher scores representing greater severity of excessive sleepiness.
Baseline to Weeks 1, 2, 3, and 4

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in the Mean Sleep Latency Time (in Minutes) on the Maintenance of Wakefulness Test (MWT)
Time Frame: Baseline to Weeks 1, 2, 3, and 4

Change from Baseline mean sleep latency (in minutes) on the MWT defined in terms of change from study baseline (prior to first dose in Period 1) to the end of each Treatment Period (Weeks 1, 2, 3, and 4).

The MWT is the standard objective measure of an individual's ability to remain awake during the daytime in a darkened, quiet environment. MWT sleep latency ranges from 0 to 40 minutes, with higher scores indicated greater ability to stay awake.
Baseline to Weeks 1, 2, 3, and 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jazz Pharmaceuticals

Investigators

  • Study Director: Millie Gottwald, PharmD, Jazz Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (Actual)

August 1, 2018

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

January 23, 2017

First Submitted That Met QC Criteria

January 27, 2017

First Posted (Estimate)

January 31, 2017

Study Record Updates

Last Update Posted (Actual)

January 9, 2020

Last Update Submitted That Met QC Criteria

January 3, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JZP166-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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