Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2025-12-24 @ 11:10 PM
NCT ID:
NCT01489969
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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01489969
Study Brief:
Protocol Section:
NCT01489969