The phase II clinical trial is designed to determine the efficacy and safety of eight different dose and formulation profiles of NG2-73 compared to placebo. The primary endpoint will be wake after sleep onset (WASO). In addition, sleep onset, as measured by latency to persistent sleep (LPS) and additional measures of sleep maintenance will be explored in several secondary endpoints.
At least 36 patients with chronic insomnia, aged up to 64 years, are expected to participate in the study. Each patient will be randomly assigned to a treatment sequence of study drug and placebo. Polysomnography will be used to objectively measure various sleep parameters.
William Koster, president and CEO, said, “Our target product profile for NG2-73 is a drug that provides rapid sleep onset and reduces wake time through the night, with patients awakening feeling refreshed and with no hangover effects.
“The clinical trial announced in October is a parallel design study and is larger, with sleep onset as its primary endpoint. In this second study, which is a cross-over design, we are primarily assessing sleep maintenance effects for NG2-73.”