wHAT CLINICAL EFFECTS wERE SEEN FOR EXCESSIVE DAYTIME SLEEPINESS (EDS) IN NARCOLEPSY?

wHAT CLINICAL EFFECTS wERE SEEN FOR EXCESSIVE DAYTIME SLEEPINESS (EDS) IN NARCOLEPSY?

XYREM significantly improved the ability to sustain wakefulness.1,2

The results of the XYREM Trial N4 showed...

  • XYREM, with or without modafinil, and at a dosage of 9 g per night, significantly reduced EDS as measured by improvements in Maintenance of Wakefulness Test (MWT) scores at week 8.1,2

Study results

Change in Wakefulness on MWT at Week 81,2*

Change in Wakefulness on MWT at Week 8*

Trial N4 Study Description

Study Design1,2
  • Randomized, double-blind, placebo-controlled, parallel-group, multicenter trial
  • Compared effects of orally administered XYREM, modafinil, and the combination of the 2 with placebo for the treatment of EDS in narcolepsy
Patients Studied1,2
  • 222 adult patients with narcolepsy with inclusion criteria featuring:
    • The use of a stimulant medication for EDS for at least 3 months, and stable dosages of 200 mg to 600 mg of modafinil daily, for at least 1 month prior to the trial, or stable doses of modafinil for at least 6 weeks prior to the trial
  • Patients were permitted to remain on antidepressant medications at unchanged dosages throughout the trial
  • Patients were not allowed to have used XYREM or any investigational therapy within the 30-day period prior to the trial
Baseline Characteristics1,2
  • Mean age: 38.6 years
  • Moderate to severe symptoms at study entry:
    • Median Epworth Sleepiness Scale (ESS) score of 15
    • Mean Maintenance of Wakefulness Test (MWT) score of 10.3 minutes
Objective1,2
  • Evaluate the efficacy of XYREM as monotherapy and in combination with modafinil compared with placebo in the treatment of EDS in narcolepsy*
Primary Efficacy Measure1,2
  • EDS as measured by the 20-minute MWT
*This trial was not designed to compare the effects of XYREM with modafinil because patients receiving modafinil were not titrated to a maximally effective dose.1

Trial N4 Study Design Flowchart1,2,4

Trial N4 Study Design
*Weeks 1–4 = XYREM 6 g per night; weeks 5–8 = XYREM 9 g per night.
Weeks 1–4 = XYREM 6 g per night + modafinil; weeks 5–8 = XYREM 9 g per night + modafinil.
Modafinil was continued at patients’ prior dose in the modafinil alone and XYREM + modafinil treatment groups.
It is recommended that XYREM be titrated at weekly intervals, by adding 1.5 g per night, from 4.5 g to the effective dosage range of 6 g to 9 g per night.1
The American Academy of Sleep Medicine (AASM) recommends sodium oxybate as a standard of care for the treatment of EDS in narcolepsy.3