The purpose of this study is to evaluate the efficacy and safety of a 5 week double-blind treatment period of VEC-162 as compared to placebo in male and female patients with primary insomnia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
322
20 mg VEC-162 (tasimelteon) capsules, PO daily for five weeks
Placebo capsules, PO daily for five weeks
50 mg VEC-162 (tasimelteon) capsules, PO daily for five weeks
Average Change From Baseline - Latency to Persistent Sleep (LPS)
Average latency to persistent sleep is defined as the length of time elapsed between lights off and onset of persistent sleep (defined as the point at which 10 minutes of uninterrupted sleep has begun as determined by PSG) between Baseline and the average of nights 1 and 8.
Time frame: Baseline, Night 1, and Night 8 measurement
Average Change From Baseline - Wake After Sleep Onset (WASO) and Total Sleep Time (TST)
Average wake after sleep onset was defined as the time spent awake between onset of sleep (latency to non-awake) and lights-on, as determined by PSG between Baseline, and the average of nights 1 and 8. Total sleep time (TST) was defined as the time spent sleeping between lights-out and lights-on, i.e., full night between Baseline, and the average of nights 1 and 8.
Time frame: Baseline, Night 1, and Night 8 measurements for WASO and TST
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