Effects of Neurexan on short-term insomnia

Evaluation of the Effects of Neurexan® on Short-Term Insomnia, Daytime Performance and Stress Response by Polysomnography (PSG), Electroencephalogram (EEG), Stress Biomarkers and Patient-Reported Outcomes (PROs)

This study tests whether Neurexan can improve sleep and reduce stress in people with short-term insomnia compared to a placebo.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Biologische Heilmittel Heel GmbH (Industry-sponsored)
• Locations: 1 site (Jena, Thuringia)
• Trial ID: NCT06278077 on ClinicalTrials.gov

What this trial studies

This clinical study evaluates the impact of Neurexan, a medication, on sleep patterns and stress in individuals experiencing short-term insomnia. Participants will be randomly assigned to receive either Neurexan or a placebo for a duration of 14 days. The primary outcome measure is sleep efficiency, assessed through Polysomnography (PSG) before and after the treatment period. Additional factors related to sleep quality will also be monitored using sleep diaries and questionnaires.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with short-term insomnia lasting less than three months and moderate symptoms.

Not a fit: Patients with chronic insomnia or those not meeting the specific inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for individuals suffering from short-term insomnia.

How similar studies have performed: Other studies have shown promising results with similar interventions for insomnia, but the specific use of Neurexan is less established.

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.

Where this trial is running

Jena, Thuringia

• Jena University Hospital, Department of Psychiatry & Psychotherapy — Jena, Thuringia, Germany (Recruiting)

Conditions Insomnia; Stress Reaction; Polysomnography; Electroencephalogram; Sleep Efficiency; Acute Insomnia; Stress dysregulation; Hyperarousal