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) ]

Subject will be instructed to drive with steady lateral position between the delineated boundaries of the slower (right) traffic lane, while maintaining a constant speed of 95 km/hr. Deviation is measured by the vehicle's speed and lateral distance to the left lane line and will be continuously recorded.


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