E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Primary (psychophysiologic) insomnia |
|
E.1.1.1 | Medical condition in easily understood language |
Sleep disorders, characterised by
- difficulties in initiating sleep;
– disorders of maintaining sleep (frequent or long awakening);
– premature awakening;
– feeling of non-restorative sleep |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 13.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10036701 |
E.1.2 | Term | Primary insomnia |
E.1.2 | System Organ Class | 10037175 - Psychiatric disorders |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The main objective of this open label clinical trial is to investigate the physiological effects on sleep after daily administration (14 days) of the IMP to patients with primary insomnia. The hypothesis is that the IMP has positive effects on certain PSG parameters thus improving the sleep quality of patients. |
|
E.2.2 | Secondary objectives of the trial |
The secondary objectives of this clinical trial are:
- To investigate the changes in the percentages of sleep stages W, N1, N2, N3, and R on the total sleep time (TST) after 14-days administration of the IMP.
- To asses and analyze the subjective sleep quality of patients using validated questionnaires and psychometric tests (Insomnia Severity Index (ISI), VIS-A/VIS-M (as a diary), “attention stress test” (d2-R)) during the trial.
- To evaluate the global clinical effect and tolerability of the IMP by the investigator and the patients.
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Male and female patients, aged 18-60 years
- Written informed consent of the patients
- Sleep onset latency value between 15 min and 45 min (Polysomnographic evaluation)
- Total sleep time value between 3 h and 7 h (Polysomnographic evaluation)
- Current diagnosis of primary insomnia using ICSD-2 criteria
|
|
E.4 | Principal exclusion criteria |
- Secondary insomnia criteria
- Serious diseases which preclude a patient’s participation in the investigator’s opinion
- Pregnancy or breast-feeding. Premenopausal women must use an approved birth control method.
- Any current diagnosis of alcohol or substance abuse/dependence (with the exception of cigarette smoking)
- Regular (≥ 4 times per week for at least 4 weeks) intake of sedatives / hypnotics / antihistamines, sedating antidepressants and beta-blockers (abstinence time: 7 days prior to PSG screening night)
- Known sensitivity to the ingredients of the IMP
- Simultaneous participation in another clinical trial or participation in a clinical trial during 6 weeks before start of this clinical trial
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Change (baseline vs. end of trial) in sleep onset latency (SOL), total sleep time (TST) and sleep efficiency (SE). |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Baseline (visit 1) and end of trial (visit 3) |
|
E.5.2 | Secondary end point(s) |
Change in:
- the percentages of sleep stages W, N1, N2, N3, and R on the total sleep time (TST)
- the subjective sleep quality of patients using questionnaires and psychometric tests:
- Insomnia Severity Index (ISI)
- VIS-A/VIS-M
- Test d2-R |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Baseline (visit 1) and end of trial (visit 3) |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
last visit of the last subject undergoing the trial (LSLV) |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 3 |
E.8.9.2 | In all countries concerned by the trial days | 0 |