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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

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ClinicalTrials.gov Identifier: NCT03037203
Recruitment Status : Recruiting
First Posted : January 31, 2017
Last Update Posted : April 3, 2018
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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 49 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
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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. Safety as assessed by the incidence of treatment emergent adverse events up until the last visit at week 5 [ Time Frame: Weekly through week 5 ]

Secondary Outcome Measures :
  1. Assess the effect of JZP110 on the Maintenance of Wakefulness Test (MWT) compared to baseline vs. placebo [ Time Frame: Weekly through week 4 ]
  2. Assess the effect of JZP110 on the Epworth Sleepiness Scale (ESS) score compared to baseline vs. placebo [ Time Frame: Weekly through week 4] ]


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Ages Eligible for Study:   35 Years to 80 Years   (Adult, Senior)
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. Baseline ESS score >10.
  4. Baseline mean sleep latency of ≤20 minutes on the MWT.

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. Prior or documented history of moderate or severe obstructive sleep apnea (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


Contacts
Contact: Jazz Pharmaceuticals 650-496-3777

Locations
United States, Arizona
Mayo Clinic Scottsdale Recruiting
Scottsdale, Arizona, United States, 85259
Principal Investigator: Shyamal Mehta         
United States, California
Southern California Institute For Respiratory Diseases, Inc. Recruiting
Los Angeles, California, United States, 90048
Principal Investigator: Roy Artal         
Pacific Research Network, Inc Completed
San Diego, California, United States, 92103
United States, Colorado
Rocky Mountain Movement Disorders Center, PC Recruiting
Englewood, Colorado, United States, 80113
Principal Investigator: Rajeev Kumar         
United States, Florida
Parkinson's Disease and Movement Disorders Center of Boca Raton Recruiting
Boca Raton, Florida, United States, 33486
Principal Investigator: Stuart Isaacson         
PAB Clinical Research Recruiting
Brandon, Florida, United States, 33511
Principal Investigator: Danial Lorch         
MD Clinical Recruiting
Hallandale Beach, Florida, United States, 33009
Principal Investigator: Beth Safirstein         
QPS MRA (Miami Research Associates) Active, not recruiting
Miami, Florida, United States, 33143
Bioclinica Research Recruiting
Orlando, Florida, United States, 32806
Principal Investigator: George Stoica         
USF Health Byrd Institute Recruiting
Tampa, Florida, United States, 33613
Principal Investigator: Robert Hauser         
United States, Kansas
University of Kansas Medical Center Research Institute, Inc. Recruiting
Kansas City, Kansas, United States, 66160
Principal Investigator: Rajesh Pahwa         
United States, Maryland
Center for Sleep & Wake Disorders Recruiting
Chevy Chase, Maryland, United States, 20815
Principal Investigator: Helene Emsellem         
United States, Michigan
Clinical Neurophysiology Services, P.C. Recruiting
Sterling Heights, Michigan, United States, 48314
Principal Investigator: Rahul Sangal         
Henry Ford Medical Center - West Bloomfield Recruiting
West Bloomfield, Michigan, United States, 48322
Principal Investigator: Peter LeWitt         
United States, Missouri
St. Lukes Hospital Medical Center Recruiting
Chesterfield, Missouri, United States, 63017
Principal Investigator: Paula Schweitzer         
United States, New York
Montefiore Sleep-Wake Disorders Center Active, not recruiting
Bronx, New York, United States, 10467
Strong Sleep Disorders Center Recruiting
Rochester, New York, United States, 14618
Principal Investigator: Michael Yurcheshen         
United States, Oklahoma
Lynn Health Science Institute Recruiting
Oklahoma City, Oklahoma, United States, 73112
Principal Investigator: Carl Griffin         
United States, Pennsylvania
Parkinson's Disease Research Unit - Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Principal Investigator: Jay Schneider         
United States, South Carolina
SleepMed of South Carolina Completed
Columbia, South Carolina, United States, 29201
United States, Washington
Evergreen Hospital Medical Center Active, not recruiting
Kirkland, Washington, United States, 98034
Premier Clinical Research - Sherman Completed
Spokane, Washington, United States, 99202
Sponsors and Collaborators
Jazz Pharmaceuticals
Investigators
Study Director: Millie Gottwald, PharmD Jazz Pharmaceuticals

Responsible Party: Jazz Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03037203     History of Changes
Other Study ID Numbers: JZP166-201
First Posted: January 31, 2017    Key Record Dates
Last Update Posted: April 3, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Parkinson Disease
Disorders of Excessive Somnolence
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Mental Disorders