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

Jazz Pharmaceuticals25 sites in 1 country66 target enrollmentJanuary 2017

ConditionsExcessive Sleepiness Parkinson Disease

InterventionsJZP-110 Placebo

DrugsJZP-110

Overview

Phase: Phase 2
Intervention: JZP-110
Conditions: Excessive Sleepiness
Sponsor: Jazz Pharmaceuticals
Enrollment: 66
Locations: 25
Primary Endpoint: Number of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Early Discontinuation
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2017

End Date

August 2018

Last Updated

6 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Jazz Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Diagnosis of idiopathic PD according to the UK PDS Brain Bank Criteria.
•Hoehn and Yahr stage 1, 2, or
•Screening and Baseline ESS scores \>11.

Exclusion Criteria

•Diagnosis of other degenerative Parkinsonian syndromes (e.g., progressive supranuclear palsy, multiple system atrophy \[MSA\], or dementia with Lewy bodies \[DLB\]).
•Usual nightly time in bed of \<6 hours, including the night before the Baseline visit.
•Untreated or inadequately treated moderate to severe OSA.
•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.