MedPath

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
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

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
GroupInterventionDescription
Arm CPlaceboPlacebo
Arm APlaceboJZP-110 and Placebo
Arm BPlaceboJZP-110 and Placebo
Arm AJZP-110JZP-110 and Placebo
Arm BJZP-110JZP-110 and Placebo
Primary Outcome Measures
NameTimeMethod
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Early DiscontinuationUp to Day 35
Secondary Outcome Measures
NameTimeMethod
Change From Baseline in Epworth Sleepiness Scale (ESS) Total ScoreBaseline 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)

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 Beach, 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

Scroll for more (15 remaining)
Southern California Institute For Respiratory Diseases, Inc.
🇺🇸Los Angeles, California, United States

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.