CompletedPhase 2

Sleep Laboratory Study to Investigate the Safety and Efficacy of Neu-P11 in Primary Insomnia Patients

United States137 participantsStarted 2011-12

Plain-language 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).

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. Male or female and aged 18-80 years (both ages included).
✓. Suffering from primary insomnia according to DSM-IV criteria (307.42 primary insomnia, Appendix 25.1) (based on a Sleep History Questionnaire (SHQ) that is given to the patient at Visit Day 0, Appendix 25.1).
✓. Reported subjective sleep latency of at least 30 minutes on at least three nights per week for at least one month and subjective WASO of at least 45 minutes per night on at least 3 nights per week for at least one month (based on the SHQ).
✓. Subjects with habitual bed time within the range of 21:00-01:00 (inclusive), as reported by the subject during screening on Day 0.
✓. If female of childbearing potential, using a reliable method of contraception during the entire study duration and for at least 3 months after study drug intake.
✓. Have not been using benzodiazepine (BZD) and non-BZD hypnotics or melatoninergic drugs for the past 2 weeks or more prior to Screening.
✓. Have not been using psychotropic treatments for the past 3 months or more prior to Screening.
✓. Are stabilized on non-psychotropic treatments for more than 3 months prior to Screening.

Exclusion criteria

What they're measuring

Latency to Persistent Sleep

Timeframe: 2 days

Trial details

NCT IDNCT01489969

SponsorNeurim Pharmaceuticals Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-05

Results submitted2018-03-29

View on ClinicalTrials.gov More Primary Insomnia trials