NCT03037203

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Jazz Pharmaceuticals · Industry
• Sex: All
• Age: 35 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Excessive Sleepiness
• Parkinson Disease

Interventions

Type	Name	Description
DRUG	JZP-110	75 mg, 150 mg, 300 mg
OTHER	Placebo

Timeline

• Start date: 2017-01-01
• Primary completion: 2018-08-01
• Completion: 2018-08-01
• First posted: 2017-01-31
• Last updated: 2020-01-09
• Results posted: 2020-01-09

Locations

25 sites across 1 country: United States