Neurexan - a Clinical Trial in Short-Term Insomnia Patients

Who can take part

• Insomnia definition according to Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) criteria; episode duration less than 3 months
• Short-term insomnia with moderate symptoms according to Insomnia Severity Index (ISI) of at least 8 and below 22 being present for at least one week, but no longer than 3 months prior to Screening Visit
• Reports habitual bedtime, defined as the time the participant attempts to sleep, between 21:00 and 01:00
• Reports regular time spent in bed, either sleeping or trying to sleep, between 6 and 9 hours
• ≥18 years of age, not older than 65 years
• Legally competent male or female patient
• Signed Informed Consent
• Females of childbearing potential must agree to maintain highly effective or acceptable birth control throughout the trial (CTFG 2020)
• Body Mass Index (BMI) between 18.5 and 29.9 kg/m2 at Screening Visit
• Use of digital device e.g., smartphone, tablet or laptop
• German speaking and reading

Who cannot take part

• Patients with insomnia symptoms present longer than 90 days prior to Screening Visit
• History of psychiatric disorders within the last 6 months prior to Screening Visit according to the Structured Clinical Interview for DSM-5® Disorders - Clinician Version (SCID-5-CV)
• Non-pharmacological insomnia therapies (e.g., cognitive behavioral therapy within the last 6 months of Screening Visit, sleep restriction therapy, complementary and alternative therapies as meditation, Traditional Chinese Medicine, aromatherapy)
• Use of nicotine during the last 6 months prior to Screening Visit
• Participation in any interventional clinical study within the past 30 days prior to Screening Visit
• History of neurological, rheumatic, chronic pain, immune, cardiovascular, pulmonary, liver/ kidney, or metabolic disorder within the last 6 months prior to Screening Visit
• Based on the diagnostic interview, reported history (within 2 years) of other sleep disorders (e.g., chronic insomnia, circadian rhythm sleep disorders, restless legs syndrome (RLS), obstructive sleep apnea (OSA)), i.e., STOPBang (SBQ) questionnaire score ≥5, International Restless Legs Scale score ≥16)
• Based on the first polysomnographic screening night at Baseline 1, insomnia due to sleep apnea or periodic limb movement disorder (PLMD): OSA (Apnea Hypopnea Index of >5 events/ hour), PLMD (Periodic Limb Movement Index (PLMI) >15 events/ hour)
• History of sensitivity to any component of Neurexan®
• Cognitive impairment (cut-off of 24 points in the Montreal Cognitive Assessment [MoCA]; at Screening Visit
• Any history of or current abuse of alcohol and/or amphetamines, benzodiazepines, cocaine, marijuana, methaqualone, methadone, opioids, propoxyphene, barbiturates, phencyclidine; or expected to take during trial participation (urine drug screening at Screening Visit and adaptation nights)
• Current use of medication affecting sleep, i.e., antidepressants, antipsychotics, diuretics, blood pressure drugs, anti-dementia drugs (e.g., piracetam), herbal and homeopathic medicine, hormone preparations (e.g., thyroxine) with the exception of hormonal contraceptives
• Active infection/ disease (C-Reactive Protein [CRP] >5 mg/l)
• Hypertension defined as systolic blood pressure ≥140 mmHg
• Patients with moderate to severe skin allergies and/or eczema
• Raynaud's disease
• Donation of blood or platelets 3 months prior to or in-between in-hospital visits
• Rotating shift work with overnight shifts
• Unwilling or unable to comply with all the requirements of the clinical trial protocol
• Use of Neurexan® within the last two weeks from Screening Visit
• Excessive consumption of xanthine-containing beverages (more than 7 cups daily of coffee or tea or other beverages containing xanthines)
• Any relationship of dependence with the Sponsor or with the Investigator
• Nocturia
• Pregnancy (as proven by positive urine pregnancy test at Screening Visit) or breastfeeding