Clinical Trial: Study Assessing Effects of JZP-110 on Driving Performance in the Treatment of Excessive Sleepiness in Narcolepsy
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Crossover On-Road Driving Study Assessing the Effect of JZP-110 on Driving Performance in Subjects With Excessive Sleepiness Due to Narcolepsy
Brief Summary: This trial is a randomized, double-blind, placebo-controlled, crossover study to evaluate the effect of JZP-110 on driving performance in subjects with excessive sleepiness due to narcolepsy.
Detailed Summary:
Sponsor: Jazz Pharmaceuticals
Current Primary Outcome: Standard deviation of lateral position (SDLP) [ Time Frame: At 2 hours post-dose (approximately at Tmax) ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Standard deviation of lateral position (SDLP) [ Time Frame: At 6 hours post-dose ]
- Proportion of subjects with improved or impaired driving on JZP-110 compared to placebo [ Time Frame: At Days 7 and 14 ]
- Standard Deviation of Speed (SDS) [ Time Frame: At Days 7 and 14 ]
- Psychomotor Vigilance Test (PVT) number of lapses [ Time Frame: At Days 7 and 14 ]Reaction Time (RT) in milliseconds > 500 milliseconds
- Psychomotor Vigilance Test (OVT) mean reaction time [ Time Frame: At Days 7 and 14 ]In milliseconds
- Psychomotor Vigilance Test (PVT) inverse reaction time [ Time Frame: At Days 7 and 14 ]Expressed as 1/reaction time in milliseconds
- Psychomotor Vigilance Test (PVT) number of errors of commission [ Time Frame: At Days 7 and 14 ]Number of responses without a stimulus or response time < 100 milliseconds
- Toronto Hospital Alert Test (THAT) [ Time Frame: At Days 7 and 14 ]10-item self-report questionnaire designed to measure perceived alertness
Original Secondary Outcome: Same as current
Information By: Jazz Pharmaceuticals
Dates:
Date Received: June 10, 2016
Date Started: June 2016
Date Completion: February 2017
Last Updated: June 21, 2016
Last Verified: June 2016