Sleep Laboratory Study to Investigate the Safety and Efficacy of Neu-P11 in Primary Insomnia Patients
Status:
Completed
Trial end date:
2013-01-01
Target enrollment:
Participant gender:
Summary
This is a phase II study. It is conducted using a randomized, double-blind, 3-arm placebo
controlled, parallel group design. Eligible patients will be randomized in a 1:1:1 ratio to
receive Neu-P11 20 mg, Neu-P11 50 mg or placebo for 4 weeks The objective of this study is to
assess the efficacy of Neu-P11 (20 and 50mg) on sleep continuity parameters in insomnia
patients aged 18-80 years, following the first two nights (immediate effect) and at the end
of 4 weeks of double-blind treatment. The primary efficacy endpoint in this study is Latency
to Persistent Sleep (LPS) measured by polysomnogram (PSG) at the first two nights of
treatment (nights 15-16 of the study; mean of two consecutive nights recordings). The
secondary endpoints are number of awakenings after sleep onset and the duration of wake after
sleep onset measured by PSG at the first two nights of treatment (nights 15-16 of the study;
mean of two consecutive nights recordings).