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

Parkinson Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03037203
• Other study ID #: JZP166-201
• Status: Completed
• Phase: Phase 2
• Start date: January 2017
• Est. completion date: August 2018

Study information

• Verified date: January 2020
• Source: Jazz Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Disorders of Excessive Somnolence
• Excessive Sleepiness
• Parkinson Disease
• Sleepiness

Intervention

Drug:
• JZP-110
75 mg, 150 mg, 300 mg

Other:
• Placebo

Locations

Country	Name	City	State
United States	Parkinson's Disease and Movement Disorders Center of Boca Raton	Boca Raton	Florida
United States	Alpine Clinical Research Center	Boulder	Colorado
United States	PAB Clinical Research	Brandon	Florida
United States	Montefiore Sleep-Wake Disorders Center	Bronx	New York
United States	St. Lukes Hospital Medical Center	Chesterfield	Missouri
United States	Center for Sleep & Wake Disorders	Chevy Chase	Maryland
United States	Rush University Medical Center	Chicago	Illinois
United States	SleepMed of South Carolina	Columbia	South Carolina
United States	Rocky Mountain Movement Disorders Center, PC	Englewood	Colorado
United States	QUEST Research Institute	Farmington Hills	Michigan
United States	MD Clinical	Hallandale Beach	Florida
United States	University of Kansas Medical Center Research Institute, Inc.	Kansas City	Kansas
United States	Evergreen Hospital Medical Center	Kirkland	Washington
United States	Southern California Institute For Respiratory Diseases, Inc.	Los Angeles	California
United States	QPS MRA (Miami Research Associates)	Miami	Florida
United States	Villages at Vanderbilt	Nashville	Tennessee
United States	Lynn Health Science Institute	Oklahoma City	Oklahoma
United States	Bioclinica Research	Orlando	Florida
United States	Parkinson's Disease Research Unit - Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Strong Sleep Disorders Center	Rochester	New York
United States	Pacific Research Network, Inc	San Diego	California
United States	Premier Clinical Research - Sherman	Spokane	Washington
United States	Clinical Neurophysiology Services, P.C.	Sterling Heights	Michigan
United States	USF Health Byrd Institute	Tampa	Florida
United States	Henry Ford Medical Center - West Bloomfield	West Bloomfield	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Jazz Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change From Baseline in the Mean Sleep Latency Time (in Minutes) on the Maintenance of Wakefulness Test (MWT)	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
Primary	Number of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Early Discontinuation		Up to Day 35
Secondary	Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score	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