Neurexan - a Clinical Trial in Short-Term Insomnia Patients

Launched by BIOLOGISCHE HEILMITTEL HEEL GMBH · Feb 19, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called Neurexan on people who have short-term insomnia, which is trouble sleeping that lasts less than three months. The main goal is to see if Neurexan can help improve how well participants sleep, compared to a placebo (a dummy pill that doesn’t contain any active ingredients). Participants will take either Neurexan or the placebo for 14 days, and researchers will measure sleep quality and efficiency using a special sleep test called Polysomnography (PSG). They'll also assess stress levels using tests that look at blood pressure and heart rate when participants are exposed to cold water.

To join the study, participants need to be between 18 and 65 years old, speak and read German, and have a specific type of insomnia that has been bothering them for at least a week but less than three months. They also need to have a regular bedtime and sleep schedule. Participants can expect to complete sleep diaries and questionnaires about their sleep and stress levels, and their sleep patterns will be monitored before and after the treatment period. This study is important because it aims to provide more information about how Neurexan may help people manage their sleep and stress better.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Insomnia definition according to Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) criteria; episode duration less than 3 months.
• • 2. 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.
• • 3. Reports habitual bedtime, defined as the time the participant attempts to sleep, between 21:00 and 01:00.
• • 4. Reports regular time spent in bed, either sleeping or trying to sleep, between 6 and 9 hours.
• • 5. ≥18 years of age, not older than 65 years.
• • 6. Legally competent male or female patient.
• • 7. Signed Informed Consent.
• • 8. Females of childbearing potential must agree to maintain highly effective or acceptable birth control throughout the trial (CTFG 2020).
• • 9. Body Mass Index (BMI) between 18.5 and 29.9 kg/m2 at Screening Visit.
• • 10. Use of digital device e.g., smartphone, tablet or laptop.
• • 11. German speaking and reading.
• Exclusion Criteria:
• • 1. Patients with insomnia symptoms present longer than 90 days prior to Screening Visit.
• • 2. 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).
• • 3. 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).
• • 4. Rotating shift work with overnight shifts.
• • 5. 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).
• • 6. History of sensitivity to any component of Neurexan®.
• • 7. Unwilling or unable to comply with all the requirements of the clinical trial protocol.
• • 8. Cognitive impairment (cut-off of 24 points in the Montreal Cognitive Assessment \[MoCA\]; at Screening Visit.
• • 9. 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).
• • 10. 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.
• • 11. Use of Neurexan® within the last two weeks from Screening Visit.
• • 12. 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).
• • 13. Excessive consumption of xanthine-containing beverages (more than 7 cups daily of coffee or tea or other beverages containing xanthines).
• • 14. Use of nicotine during the last 6 months prior to Screening Visit.
• • 15. Participation in any interventional clinical study within the past 30 days prior to Screening Visit.
• • 16. Any relationship of dependence with the Sponsor or with the Investigator.
• • 17. Active infection/ disease (C-Reactive Protein \[CRP\] \>5 mg/l).
• • 18. Hypertension defined as systolic blood pressure ≥140 mmHg.
• • 19. History of neurological, rheumatic, chronic pain, immune, cardiovascular, pulmonary, liver/ kidney, or metabolic disorder within the last 6 months prior to Screening Visit.
• • 20. Nocturia.
• • 21. Pregnancy (as proven by positive urine pregnancy test at Screening Visit) or breastfeeding.
• • 22. Patients with moderate to severe skin allergies and/or eczema.
• • 23. Raynaud's disease.
• • 24. Donation of blood or platelets 3 months prior to or in-between in-hospital visits.