Clinical Trial: 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
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: 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 Sub
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 Summary:
Sponsor: Jazz Pharmaceuticals
Current Primary Outcome: Safety as assessed by the incidence of treatment emergent adverse events up until the last visit at week 5 [ Time Frame: Weekly through week 5 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Assess the effect of JZP110 on the Maintenance of Wakefulness Test (MWT) compared to baseline vs. placebo [ Time Frame: Weekly through week 4 ]
- Assess the effect of JZP110 on the Epworth Sleepiness Scale (ESS) score compared to baseline vs. placebo [ Time Frame: Weekly through week 4] ]
Original Secondary Outcome: Same as current
Information By: Jazz Pharmaceuticals
Dates:
Date Received: January 23, 2017
Date Started: January 2017
Date Completion: April 2018
Last Updated: April 3, 2017
Last Verified: April 2017
