E2006-A001-108 is a 4-period crossover study designed to demonstrate that the mean change from baseline in postural stability (worsening) when participants are awakened at approximately 4 hours postdose is significantly less after lemborexant than after zolpidem tartrate extended release following a single-dose administration at bedtime.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
60
NeuroTrials Research, Inc
Atlanta, Georgia, United States
Clinilabs, Inc
New York, New York, United States
Wake Research Assoicates, LLC
Raleigh, North Carolina, United States
Community Research Management Associates d/b/a CTI Clinical Research Center
Cincinnati, Ohio, United States
Change from time-matched baseline in postural stability for LEM5 and LEM10 compared to zolpidem (ZOL) at approximately 4 hours postdose
Magnitude of body sway upon being awakened at approximately 4 hours after receiving lemborexant 5 milligrams (mg) (LEM5), lemborexant 10 mg (LEM10), zolpidem 6.25 mg, or placebo.
Time frame: approximately 4 hours postdose at each of 4 single-dose treatment periods (up to 43 days)
Change from time-matched baseline in postural stability for LEM5 and LEM10 compared to ZOL and placebo (PBO) at approximately 8 hours postdose
Time frame: approximately 4 hours postdose at each of 4 single-dose treatment periods (up to 43 days)
Change from time-matched baseline in postural stability for LEM5 and LEM10 compared to PBO at approximately 4 hours postdose
Time frame: approximately 4 hours postdose at each of 4 single-dose treatment periods (up to 43 days)
Change from time-matched baseline in auditory awakening threshold (AAT) for LEM5 and LEM10 compared to ZOL and PBO at approximately 4 hours postdose
Time frame: approximately 4 hours postdose at each of 4 single-dose treatment periods (up to 43 days)
Change from time-matched baseline on summary variables from power of attention for LEM5 and LEM10 compared to ZOL and PBO at approximately 4 hours postdose
Time frame: approximately 4 hours postdose at each of 4 single-dose treatment periods (up to 43 days)
Change from time-matched baseline on summary variables from power of attention for LEM5 and LEM10 compared to ZOL and PBO at approximately 8 hours postdose
Time frame: approximately 4 hours postdose at each of 4 single-dose treatment periods (up to 43 days)
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Single dose of placebo administered within 5 minutes before bedtime.
Change from time-matched baseline on summary variables from continuity of attention for LEM5 and LEM10 compared to ZOL and PBO at approximately 4 hours postdose
Time frame: approximately 4 hours postdose at each of 4 single-dose treatment periods (up to 43 days)
Change from time-matched baseline on summary variables from continuity of attention for LEM5 and LEM10 compared to ZOL and PBO at approximately 8 hours postdose
Time frame: approximately 4 hours postdose at each of 4 single-dose treatment periods (up to 43 days)
Change from time-matched baseline on summary variables from quality of memory for LEM5 and LEM10 compared to ZOL and PBO at approximately 4 hours postdose
Time frame: approximately 4 hours postdose at each of 4 single-dose treatment periods (up to 43 days)
Change from time-matched baseline on summary variables from quality of memory for LEM5 and LEM10 compared to ZOL and PBO at approximately 8 hours postdose
Time frame: approximately 4 hours postdose at each of 4 single-dose treatment periods (up to 43 days)
Change from time-matched baseline on summary variables from speed of memory retrieval for LEM5 and LEM10 compared to ZOL and PBO at approximately 4 hours postdose
Time frame: approximately 4 hours postdose at each of 4 single-dose treatment periods (up to 43 days)
Change from time-matched baseline on summary variables from speed of memory retrieval for LEM5 and LEM10 compared to ZOL and PBO at approximately 8 hours postdose
Time frame: approximately 4 hours postdose at each of 4 single-dose treatment periods (up to 43 days)
Number of participants with any serious adverse event and number of participants with any non-serious adverse event
Time frame: up to 72 days