E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Nonorganic insomnia according to ICD 10 with the code F51.0 |
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E.1.1.1 | Medical condition in easily understood language |
Inability to fall or stay asleep |
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E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Mental Disorders [F03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10022438 |
E.1.2 | Term | Insomnia (non-organic) |
E.1.2 | System Organ Class | 100000014712 |
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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 objective of the trial is to assess the effectiveness of a combined treatment with Valerian extract (Euvegal®) and Lavender oil (Lasea®) in patients with inability to fall or stay asleep. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patients not able to fall or stay asleep with a diagnosis of non organic insomnia according to ICD 10 F 51.0 and according to PSG screening criteria: 2-night mean latency to persisting sleep (LPS) > 30 min, Wake-time during sleep (WTDS) > 30 min and Total sleep time (TST) > 180 min and < 390 min. 2. No organic reason for sleep disturbances. 3. Insomnia Severity Index (ISI) score >= 15 at screening. 4. Patients otherwise healthy / medically stable on the basis of clinical laboratory tests, medical history, vital signs, and 12-lead ECG performed at screening. 5. Patients aged between 18 and 50 years (at the time of informed consent). 6. Body mass index (BMI) between 18 and 30 kg/m2 inclusive 7. Written informed consent to participate in the clinical trial, to randomised treatment allocation and to data recording in accordance with applicable laws. |
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E.4 | Principal exclusion criteria |
1. Participation in another clinical trial at the same time or exposure to any new investigational agent within 90 days prior to study drug administration. 2. Women of postmenopausal state (>45 years of age with amenorrhea for at least 12 months). 3. Using nicotine-containing products moderately (≥ 10 cigarettes/day), or within 120 minutes of bedtime during the clinical trial. 4. Consuming > 5 caffeine-containing beverages (tea/coffee/cocoa/cola) /day within the last two months . 5. Patients who do not agree to abstain from caffeine-containing products 6 hours before dosing of investigational medicinal product (IMP). 6. Presence or history of clinically relevant allergies or a known or suspected intolerance or hypersensitivity to one of the IMP, closely related compounds, any of the stated ingredients or to excipients contained in the tablets/capsules. 7. Female patients, who are pregnant, breast-feeding or of childbearing potential without safe contraception. 8. Any clinically relevant concomitant disease, gastrointestinal disorders with uncertain absorption of orally administered drugs, severe renal dysfunction; hepatic impairment (serum ASAT, ALAT or gamma-GT above 2 times the upper limit of the reference range in symptom-free patients without clinical features of liver disease); hypothyroidism or hyperthyroidism; significant cardiac, vascular, pulmonary, endocrine, neurologic, hematologic, rheumatologic, or metabolic disturbances. 9. Current diagnosis of a psychotic disorder, major depressive disorder, bipolar disorder, mental retardation, or cluster B personality disorder. 10. Clinically significant acute illness within seven days prior to first study drug administration. 11. Insomnia related to restless leg syndrome on first or second night PSG recording, sleep breathing disorder on first or second night PSG recording, narcolepsy, obstructive sleep apnea/hypopnea, central sleep apnea, sleep-related hypoventilation, circadian rhythm sleep-wake disorders, substance/medication-induced sleep disorder or parasomnias. 12. Night-shift workers. 13. Patients who have traveled across 3 different time zones within 1 week prior to screening PSG. 14. Patients who are HIV positive or hepatitis B positive. 15. History of substance or alcohol use disorder according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) criteria within 6 months before screening or positive test result(s) for alcohol and/or drugs of abuse at screening or admission before every PSG night. 16. Donation of one or more units (approximately 450 mL) of blood or acute loss of an equivalent amount of blood within 90 days prior to study drug administration. 17. Intake of drugs not permitted during the trial. 18. Patients not able to swallow. 19. Psychological and/or emotional problems, which would render the informed consent invalid, or limit the ability of the subject to comply with the study requirements. 20. Is unable to read and understand the consent forms and patient reported outcomes, complete study-related procedures, and/or communicate with the study staff. 21. Vulnerable subjects (e.g., a person kept in detention). 22. Any condition that in the opinion of the investigator would complicate or compromise the study or the well-being of the patient. 23. Employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator.
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E.5 End points |
E.5.1 | Primary end point(s) |
Objective endpoints (polysomnography): Wake time during sleep (WTDS), Sleep onset latency (SOL), Wake time after sleep onset (WASO), Number of awakenings after sleep onset (NAASO), Total sleep time (TST), Latency to persistent sleep (LPS), Sleep efficiency (SE), Wake time after sleep (WTAS). Subjective endpoints: Subjective sleep onset latency (sSOL), Subjective wake time after sleep onset (sWASO), subjective number of awakenings after sleep onset (sNAASO), Subjective total sleep time (sTST), Quality of sleep (last night), Leeds sleep evaluation questionnaire (LSEQ). Subsequent daytime functioning: Modified Karolinska sleepiness scale (mKSS), Digit-symbol-substitution test (DSST). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Day 3 of each treatment period (polysomnography), Next morning after Day 3 (subjective endpoints and subsequent daytime functioning), Next morning after Day 1 (sSOL, sWASO, sNAASO, sTST,quality of sleep (last night) and subsequent mKKS). |
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E.5.2 | Secondary end point(s) |
Safety variables: adverse events, vital signs, physical examination findings, ECG.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
adverse events on every visit, vital signs on Day 3 of each period, Physical examination findings and ECG on End of study visit |
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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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
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 | Yes |
E.8.2.3.1 | Comparator description |
Combination of Lasea and Euvegal Balance is compared to the single substances plus Placebo |
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E.8.2.4 | Number of treatment arms in the trial | 3 |
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
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The end of the trial is defined as the date of the report synopsis (date of internal summary of results) due to follow up of patients with queries and adverse events |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | |