Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Long Term Safety Study of MK-4305 in Patients With Primary Insomnia
Brief Summary: This study will establish the safety and tolerability of suvorexant (MK-4305) when administered for up to 14 months. Participants will be randomized to receive suvorexant or placebo for a 12-month double-blind (DB) Treatment Phase. Participants who complete the 12-month DB Treatment Phase will enter a 2-month DB Randomized Discontinuation Phase. At the time of initial randomization, participants assigned to receive suvorexant during the initial 12-month Treatment Phase will be simultaneously randomized, in a 1:1 ratio, to receive either suvorexant or placebo during the 2-month Randomized Discontinuation Phase. Participants randomized to receive placebo in the initial 12-month Treatment Phase will continue to receive placebo during the 2-month Randomized Discontinuation Phase.

The first 3 nights of the Randomized Discontinuation Phase are referred to as the Run-Out Phase, and will assess rebound and withdrawal.


Options:
A: Suvorexant HD Versus Placebo: Change From Baseline in Mean Subjective Total Sleep Time (sTSTm) at Month 1 (Baseline and Month 1); Suvorexant HD Versus Placebo: Change From Baseline in sTSTm at Month 3 (Baseline and Month 3); Suvorexant HD Versus Placebo: Change From Baseline in Wakefulness After Persistent Sleep Onset (WASO) at Month 1 (Baseline and Month 1); Suvorexant HD Versus Placebo: Change From Baseline in WASO at Month 3 (Baseline and Month 3); Suvorexant HD Versus Placebo: Change From Baseline in Mean Subjective Time to Sleep Onset (sTSOm) at Month 1 (Baseline and Month 1); Suvorexant HD Versus Placebo: Change From Baseline in sTSOm at Month 3 (Baseline and Month 3); Suvorexant HD Versus Placebo: Change From Baseline in Latency to Onset of Persistent Sleep (LPS) at Month 1 (Baseline and Month 1); Suvorexant HD Versus Placebo: Change From Baseline in LPS at Month 3 (Baseline and Month 3); Number of Participants With an Adverse Event (AE) During 3-Month DB TRT Phase (Up to 3 months); Number of Participants Who Discontinued Study Drug Due to an AE Occurring During 3-Month DB TRT Phase (Up to 3 months)
B: Pittsburgh Sleep Quality Index (8 weeks)
C: Percentage of Participants Who Experienced Cataplexy Adverse Events (AEs) During the Double-Blind (DB) Treatment Phase (From the first day of study treatment up to 12 months); Percentage of Participants Who Experienced Sleep Paralysis AEs During the DB Treatment Phase (From the first day of study treatment up to 12 months); Percentage of Participants Who Experienced Complex Sleep-related Behaviors AEs During the DB Treatment Phase (From the first day of study treatment up to 12 months); Percentage of Participants Who Experienced Falls AEs During the DB Treatment Phase (From the first day of study treatment up to 12 months); Percentage of Participants Who Experienced Suicidal Ideation and/or Behavior AEs During the DB Treatment Phase (From the first day of study treatment up to 12 months); Percentage of Participants Who Experienced Hypnagogic/Hypnopompic Hallucinations AEs During the DB Treatment Phase (From the first day of study treatment up to 12 months); Percentage of Participants Who Experienced Selected AEs Associated With Potential for Abuse During the DB Treatment Phase (From the first day of study treatment up to 12 months)
D: Change from Baseline in Nighttime Total Sleep Time (Baseline, 14 days follow-up)

Answer: C