CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 66 enrolled
Drug / intervention
JZP-110 +1 moredrug
Likely dose
JZP-110 75 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03037203
NCT03037203Phase 2Completed

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 Pharmaceuticals·interventional·Posted Jan 31, 2017·Updated Jan 9, 2020

In Brief

A Phase 2 clinical trial evaluating JZP-110 and Placebo for Excessive Sleepiness and Parkinson Disease. Completed, enrolled 66 participants across 25 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedJan 31, 2017
Enrollment StartJan 1, 2017
Primary CompletionAug 1, 2018
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 9.4 years ago

Interventions

JZP-110drug

75 mg, 150 mg, 300 mg

Placeboother