Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03037203
Recruitment Status : Completed
First Posted : January 31, 2017
Results First Posted : January 9, 2020
Last Update Posted : January 9, 2020
Sponsor:
Information provided by (Responsible Party):
Jazz Pharmaceuticals

Brief 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.

Condition or disease Intervention/treatment Phase
Excessive Sleepiness Parkinson Disease Drug: JZP-110 Other: Placebo Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2017
Actual Primary Completion Date : August 2018
Actual Study Completion Date : August 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm A
JZP-110 and Placebo
Drug: JZP-110
75 mg, 150 mg, 300 mg

Other: Placebo
Experimental: Arm B
JZP-110 and Placebo
Drug: JZP-110
75 mg, 150 mg, 300 mg

Other: Placebo
Placebo Comparator: Arm C
Placebo
Other: Placebo



Primary Outcome Measures :
  1. Number of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Early Discontinuation [ Time Frame: Up to Day 35 ]

Secondary Outcome Measures :
  1. 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.



Other Outcome Measures:
  1. 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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   35 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03037203


Locations
Hide Hide 25 study locations
Layout table for location information
United States, California
Southern California Institute For Respiratory Diseases, Inc.
Los Angeles, California, United States, 90048
Pacific Research Network, Inc
San Diego, California, United States, 92103
United States, Colorado
Alpine Clinical Research Center
Boulder, Colorado, United States, 80301
Rocky Mountain Movement Disorders Center, PC
Englewood, Colorado, United States, 80113
United States, Florida
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, United States, 33486
PAB Clinical Research
Brandon, Florida, United States, 33511
MD Clinical
Hallandale Beach, Florida, United States, 33009
QPS MRA (Miami Research Associates)
Miami, Florida, United States, 33143
Bioclinica Research
Orlando, Florida, United States, 32806
USF Health Byrd Institute
Tampa, Florida, United States, 33613
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Kansas
University of Kansas Medical Center Research Institute, Inc.
Kansas City, Kansas, United States, 66160
United States, Maryland
Center for Sleep & Wake Disorders
Chevy Chase, Maryland, United States, 20815
United States, Michigan
QUEST Research Institute
Farmington Hills, Michigan, United States, 48334
Clinical Neurophysiology Services, P.C.
Sterling Heights, Michigan, United States, 48314
Henry Ford Medical Center - West Bloomfield
West Bloomfield, Michigan, United States, 48322
United States, Missouri
St. Lukes Hospital Medical Center
Chesterfield, Missouri, United States, 63017
United States, New York
Montefiore Sleep-Wake Disorders Center
Bronx, New York, United States, 10467
Strong Sleep Disorders Center
Rochester, New York, United States, 14618
United States, Oklahoma
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States, 73112
United States, Pennsylvania
Parkinson's Disease Research Unit - Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
SleepMed of South Carolina
Columbia, South Carolina, United States, 29201
United States, Tennessee
Villages at Vanderbilt
Nashville, Tennessee, United States, 37232
United States, Washington
Evergreen Hospital Medical Center
Kirkland, Washington, United States, 98034
Premier Clinical Research - Sherman
Spokane, Washington, United States, 99202
Sponsors and Collaborators
Jazz Pharmaceuticals
Investigators
Layout table for investigator information
Study Director: Millie Gottwald, PharmD Jazz Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by Jazz Pharmaceuticals:
Study Protocol  [PDF] January 26, 2018
Statistical Analysis Plan  [PDF] October 10, 2018


Layout table for additonal information
Responsible Party: Jazz Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03037203    
Other Study ID Numbers: JZP166-201
First Posted: January 31, 2017    Key Record Dates
Results First Posted: January 9, 2020
Last Update Posted: January 9, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Parkinson Disease
Disorders of Excessive Somnolence
Sleepiness
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Mental Disorders