Nonorganic insomnia according to ICD 10 with the code F51.0 MedDRA version: 20.0 Level: LLT Classification code 10022438 Term: Insomnia (non-organic) System Organ Class: 100000014712
Conditions
Interventions
Trade Name: Lasea
Product Name: Silexan
Product Code: WS 1265
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: Lavender Oil
Sponsors
Dr. Willmar Schwabe GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
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 = 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: Not applicable;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).; 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). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety variables: adverse events, vital signs, physical examination findings, ECG. ;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 | — |
Countries
Germany
Contacts
Public ContactClinical Research Department
Dr. Willmar Schwabe GmbH & Co. KG
Outcome results
None listed