Sleep Laboratory Study to Investigate the Safety and Efficacy of Neu-P11 in Primary Insomnia Patients
Condition: Primary Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Intervention: Neu-P11
Intervention description: 1 tablet daily 1-2 before bed time for 28 days of double blind treatment
Intervention MeSH terms: Melatonin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 137.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: sleep latency; Sleep maintenance; Sleep fragmentation; Polysomnography

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).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female and aged 18-80 years (both ages included).

          2. 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).

          3. 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).

          4. Subjects with habitual bed time within the range of 21:00-01:00 (inclusive), as
             reported by the subject during screening on Day 0.

          5. 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.

          6. Have not been using benzodiazepine (BZD) and non-BZD hypnotics or melatoninergic drugs
             for the past 2 weeks or more prior to Screening.

          7. Have not been using psychotropic treatments for the past 3 months or more prior to
             Screening.

          8. Are stabilized on non-psychotropic treatments for more than 3 months prior to
             Screening.

          9. Are willing to sign a written informed consent to participate in the study.

             • After initial screening, recruited patients will enter a 2 week placebo
             baseline/eligibility period.

             Patients will be admitted into a sleep lab and will continue to the double blind
             treatment phase if polysomnography (PSG) results meet the following criteria:

         10. Mean LPS ≥30 minutes on both PSG screening nights, with neither night <15 minutes.

         11. Mean total sleep time (TST) ≤390 minutes, or mean WASO ≥30 minutes on both of the 2
             PSG screening nights, with neither night <15 minutes.

        Exclusion Criteria:

          1. According to DSM IV, subjects belonging to the following groups are excluded: 780.59
             (breathing related sleep disorder); 307.45 (circadian rhythm sleep disorder); 307.47
             (dyssomnia not otherwise specified); 780.xx (sleep disorder due to general medical
             condition)

          2. Subjects suffering from insomnia secondary to other causes according to the sleep
             history questionnaire.

          3. Subjects with sleep disorders detected during PSG inclusion/habituation night, such as
             sleep apnea/hypopnea and periodic leg movement syndrome (with arousal) (PLMAI>10
             and/or AHI > 10 per hour).

          4. Use of psychotropic treatments for the past 3 months and during the study.

          5. Use of strong CYP inhibitors in the preceding 3 months and during the study

          6. Use of benzodiazepines or other hypnotics during preceding two weeks (including all
             benzodiazepines; zopiclone, zolpidem, zaleplon, barbiturates, buspirone and
             hydroxyzine).

          7. Alcohol intake - no more than 2 alcoholic drinks per day and any consumption less than
             2 hours before study drug intake.

          8. Immunosuppressive medication in the preceding 3 months and during the study

          9. Severe neurological, psychiatric disorders especially psychosis, anxiety and
             depression

         10. Intercurrent acute or chronic somatic diseases likely to interact with sleep (for
             example: chronic pain from any etiology, benign prostatic hypertrophy likely to
             require surgery in the coming six months)