Conditions: Primary Insomnia
Keywords: sleep latency Sleep maintenance Sleep fragmentation Polysomnography
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 137
Healthy volunteers: no

Brief 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).

Detailed description:

Arms:
arm 1: Neu-P11 dose of 20 mg arm 2: Neu-P11 dose of 50 mg arm 3: matching placebo

Interventions: intervention 1: Neu-P11
Intervention descriptions: intervention 1: 1 tablet daily 1-2 before bed time for 28 days of double blind treatment

Protocol document: