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
NCT ID: NCT03037203
Last Updated: 2020-01-09
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
66 participants
INTERVENTIONAL
2017-01-31
2018-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Use of Zolpidem in Parkinson's Disease
NCT01351168
Study of the Symptomatic Effects of Nocturnal Sodium Oxybate in Parkinson's Disease
NCT02111122
Trial of Xyrem for Excessive Daytime Sleepiness and Sleep Disturbance in Parkinson's Disease (PD)
NCT00641186
A Study to Test the Safety, Tolerability, and Pharmacokinetics of UCB0599 in Healthy Study Participants and Patients With Parkinson's Disease (PD)
NCT04875962
Staccato Apomorphine Multi-dose PK and PD in Patients With Parkinson's Disease
NCT04157933
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm A
JZP-110 and Placebo
JZP-110
75 mg, 150 mg, 300 mg
Placebo
Arm B
JZP-110 and Placebo
JZP-110
75 mg, 150 mg, 300 mg
Placebo
Arm C
Placebo
Placebo
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
JZP-110
75 mg, 150 mg, 300 mg
Placebo
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Hoehn and Yahr stage 1, 2, or 3.
3. Screening and Baseline ESS scores \>11.
Exclusion Criteria
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.
35 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Jazz Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Millie Gottwald, PharmD
Role: STUDY_DIRECTOR
Jazz Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Rush University Medical Center
Chicago, Illinois, United States
University of Kansas Medical Center Research Institute, Inc.
Kansas City, Kansas, United States
Center for Sleep & Wake Disorders
Chevy Chase, Maryland, United States
QUEST Research Institute
Farmington Hills, Michigan, United States
Clinical Neurophysiology Services, P.C.
Sterling Heights, Michigan, United States
Henry Ford Medical Center - West Bloomfield
West Bloomfield, Michigan, United States
St. Lukes Hospital Medical Center
Chesterfield, Missouri, United States
Strong Sleep Disorders Center
Rochester, New York, United States
Montefiore Sleep-Wake Disorders Center
The Bronx, New York, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Parkinson's Disease Research Unit - Thomas Jefferson University
Philadelphia, Pennsylvania, United States
SleepMed of South Carolina
Columbia, South Carolina, United States
Villages at Vanderbilt
Nashville, Tennessee, United States
Evergreen Hospital Medical Center
Kirkland, Washington, United States
Premier Clinical Research - Sherman
Spokane, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
JZP166-201
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.