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

Phase 2

Completed

• Conditions: Excessive Sleepiness; Parkinson Disease
• Interventions: Other: Placebo; Drug: JZP-110

• Registration Number: NCT03037203
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01
• Study First Submitted: 2017-01-23
• Study First Submitted QC: 2017-01-27
• Study First Posted: 2017-01-31
• Primary Completion: 2018-08
• Study Completion: 2018-08
• Results First Submitted: 2019-08-16
• Status Verified: 2020-01
• Results First Submitted QC: 2020-01-03
• Last Update Submitted: 2020-01-03
• Results First Posted: 2020-01-09
• Last Update Posted: 2020-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm C	Placebo	Placebo
Arm A	Placebo	JZP-110 and Placebo
Arm B	Placebo	JZP-110 and Placebo
Arm A	JZP-110	JZP-110 and Placebo
Arm B	JZP-110	JZP-110 and Placebo

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Early Discontinuation	Up to Day 35

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score	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.

Trial Locations

Locations (25)

Bioclinica Research; 🇺🇸 Orlando, Florida, United States

PAB Clinical Research; 🇺🇸 Brandon, Florida, United States

MD Clinical; 🇺🇸 Hallandale Beach, Florida, United States

Henry Ford Medical Center - West Bloomfield; 🇺🇸 West Bloomfield, Michigan, United States

Center for Sleep & Wake Disorders; 🇺🇸 Chevy Chase, Maryland, United States

Montefiore Sleep-Wake Disorders Center; 🇺🇸 Bronx, New York, United States

Strong Sleep Disorders Center; 🇺🇸 Rochester, New York, United States

Evergreen Hospital Medical Center; 🇺🇸 Kirkland, Washington, United States

Premier Clinical Research - Sherman; 🇺🇸 Spokane, Washington, United States

University of Kansas Medical Center Research Institute, Inc.; 🇺🇸 Kansas City, Kansas, United States

Alpine Clinical Research Center; 🇺🇸 Boulder, Colorado, United States

Parkinson's Disease and Movement Disorders Center of Boca Raton; 🇺🇸 Boca Raton, Florida, United States

QPS MRA (Miami Research Associates); 🇺🇸 Miami, Florida, United States

USF Health Byrd Institute; 🇺🇸 Tampa, Florida, United States

Southern California Institute For Respiratory Diseases, Inc.; 🇺🇸 Los Angeles, California, United States

Clinical Neurophysiology Services, P.C.; 🇺🇸 Sterling Heights, Michigan, United States

Pacific Research Network, Inc; 🇺🇸 San Diego, California, United States

Rocky Mountain Movement Disorders Center, PC; 🇺🇸 Englewood, Colorado, United States

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States

Villages at Vanderbilt; 🇺🇸 Nashville, Tennessee, United States

QUEST Research Institute; 🇺🇸 Farmington Hills, Michigan, United States

St. Lukes Hospital Medical Center; 🇺🇸 Chesterfield, Missouri, 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