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01
Overview
Phase 3, randomised, double-blind trial in Insomnia comparing Gaboxadol 15 mg with Placebo (2 arms). Primary endpoints: Wake After Sleep Onset and Latency to Persistent Sleep. Started Sep 2006; status: terminated.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Gaboxadol 15 mg
MK0928 15 mg
Placebo
Placebo Comparator
03
Who it enrols
Adult patients with Primary Insomnia, willing to stay overnight at a sleep laboratory for 7 nights, with a bedtime between 9pm and 1am. Patients with substance abuse, bipolar/psychotic disorders, other sleep disorders (narcolepsy, apnea, RLS), or recent malignancy are excluded.
04
Endpoints
Primary
Wake After Sleep Onset
Latency to Persistent Sleep
Secondary
Subjective Total Sleep Time
Subjective Time to Sleep Onset
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