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
1 other identifier
interventional
66
1 country
25
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2017
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
January 23, 2017
CompletedFirst Posted
Study publicly available on registry
January 31, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2018
CompletedResults Posted
Study results publicly available
January 9, 2020
CompletedJanuary 9, 2020
January 1, 2020
1.6 years
January 23, 2017
August 16, 2019
January 3, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Early Discontinuation
Up to Day 35
Secondary Outcomes (1)
Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score
Baseline to Weeks 1, 2, 3, and 4
Other Outcomes (1)
Change From Baseline in the Mean Sleep Latency Time (in Minutes) on the Maintenance of Wakefulness Test (MWT)
Baseline to Weeks 1, 2, 3, and 4
Study Arms (3)
Arm A
EXPERIMENTALJZP-110 and Placebo
Arm B
EXPERIMENTALJZP-110 and Placebo
Arm C
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of idiopathic PD according to the UK PDS Brain Bank Criteria.
- Hoehn and Yahr stage 1, 2, or 3.
- Screening and Baseline ESS scores \>11.
You may not qualify if:
- Diagnosis of other degenerative Parkinsonian syndromes (e.g., progressive supranuclear palsy, multiple system atrophy \[MSA\], or dementia with Lewy bodies \[DLB\]).
- Usual nightly time in bed of \<6 hours, including the night before the Baseline visit.
- Untreated or inadequately treated moderate to severe OSA.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Southern California Institute For Respiratory Diseases, Inc.
Los Angeles, California, 90048, United States
Pacific Research Network, Inc
San Diego, California, 92103, United States
Alpine Clinical Research Center
Boulder, Colorado, 80301, United States
Rocky Mountain Movement Disorders Center, PC
Englewood, Colorado, 80113, United States
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, 33486, United States
PAB Clinical Research
Brandon, Florida, 33511, United States
MD Clinical
Hallandale, Florida, 33009, United States
QPS MRA (Miami Research Associates)
Miami, Florida, 33143, United States
Bioclinica Research
Orlando, Florida, 32806, United States
USF Health Byrd Institute
Tampa, Florida, 33613, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
University of Kansas Medical Center Research Institute, Inc.
Kansas City, Kansas, 66160, United States
Center for Sleep & Wake Disorders
Chevy Chase, Maryland, 20815, United States
QUEST Research Institute
Farmington Hills, Michigan, 48334, United States
Clinical Neurophysiology Services, P.C.
Sterling Heights, Michigan, 48314, United States
Henry Ford Medical Center - West Bloomfield
West Bloomfield, Michigan, 48322, United States
St. Lukes Hospital Medical Center
Chesterfield, Missouri, 63017, United States
Strong Sleep Disorders Center
Rochester, New York, 14618, United States
Montefiore Sleep-Wake Disorders Center
The Bronx, New York, 10467, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112, United States
Parkinson's Disease Research Unit - Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
SleepMed of South Carolina
Columbia, South Carolina, 29201, United States
Villages at Vanderbilt
Nashville, Tennessee, 37232, United States
Evergreen Hospital Medical Center
Kirkland, Washington, 98034, United States
Premier Clinical Research - Sherman
Spokane, Washington, 99202, United States
Related Publications (1)
Videnovic A, Amara AW, Comella C, Schweitzer PK, Emsellem H, Liu K, Sterkel AL, Gottwald MD, Steinerman JR, Jochelson P, Zomorodi K, Hauser RA. Solriamfetol for Excessive Daytime Sleepiness in Parkinson's Disease: Phase 2 Proof-of-Concept Trial. Mov Disord. 2021 Oct;36(10):2408-2412. doi: 10.1002/mds.28702. Epub 2021 Jun 30.
PMID: 34191352DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director, Disclosure & Transparency
- Organization
- Jazz Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Millie Gottwald, PharmD
Jazz Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 23, 2017
First Posted
January 31, 2017
Study Start
January 1, 2017
Primary Completion
August 1, 2018
Study Completion
August 1, 2018
Last Updated
January 9, 2020
Results First Posted
January 9, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will not share