InsomniaPhase 2NEUREXAN SLEEPNCT06278077
Neurexan - a Clinical Trial in Short-Term Insomnia Patients
A Phase 2 study testing Neurexan in people with Insomnia and Stress Reaction, run by Biologische Heilmittel Heel GmbH at 1 site in Germany.
Trial summary
This clinical study aims to understand the effects of a medication called Neurexan on sleep patterns and stress in people with short-term insomnia. The study involves comparing Neurexan to a placebo - a tablet that looks like Neurexan but lacks active ingredients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Insomnia, Stress Reaction
- What is being tested?
- Neurexan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 1 siteGermany
- Study dates
- 6 Sep 2023to 16 Feb 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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 join
- Patients with insomnia symptoms present longer than 90 days 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).
- Rotating shift work with overnight shifts.
- 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).
- History of sensitivity to any component of Neurexan®.
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- Unwilling or unable to comply with all the requirements of the clinical trial protocol.
- 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.
- Use of Neurexan® within the last two weeks from Screening Visit.
- 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).
- Excessive consumption of xanthine-containing beverages (more than 7 cups daily of coffee or tea or other beverages containing xanthines).
- 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.
- Any relationship of dependence with the Sponsor or with the Investigator.
- Active infection/ disease (C-Reactive Protein [CRP] >5 mg/l).
- Hypertension defined as systolic blood pressure ≥140 mmHg.
- History of neurological, rheumatic, chronic pain, immune, cardiovascular, pulmonary, liver/ kidney, or metabolic disorder within the last 6 months prior to Screening Visit.
- Nocturia.
- Pregnancy (as proven by positive urine pregnancy test at Screening Visit) or breastfeeding.
- 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.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Jena University Hospital, Department of Psychiatry & Psychotherapy
Jena, Thuringia, 07743
About this study
Official title: 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 clinical study aims to understand the effects of a medication called Neurexan on sleep patterns and stress in people with short-term insomnia. The study involves comparing Neurexan to a placebo - a tablet that looks like Neurexan but lacks active ingredients. The main goal of the study is to determine if Neurexan can enhance sleep efficiency in those with short-term insomnia. Sleep efficiency, which is the proportion of time spent asleep in relation to total time in bed, including attempts to fall asleep, will be assessed through Polysomnography (PSG). PSG examines various sleep characteristics such as brain activity, muscle and heart activity, and breathing.
Participants will take either Neurexan or the placebo for 14 days. Sleep efficiency will be evaluated using PSG before and after the treatment period. Additionally, sleep quality-related factors will be investigated using PSG data, sleep diaries, and participant-completed questionnaires.
Read more
The study will also investigate Neurexan's impact on stress levels. This will be assessed using the Cold Pressor Test, which measures stress through having the participant immerse their hand into ice water, and measuring changes in blood pressure and heart rate, both indicators of stress. In addition, blood and saliva samples collected before and after treatment with Neurexan or placebo, will be analyzed for stress-related hormones such as cortisol. Patient questionnaires and Electroencephalography (EEG), a non-invasive brain activity recording, will further assess stress symptoms.
Researchers will analyze data related to sleep efficiency, sleep quality, and stress symptoms. By comparing outcomes before and after Neurexan or placebo treatment, the study aims to detect improvements in these areas. Positive results with Neurexan but not with the placebo would provide robust evidence for Neurexan's efficacy in addressing sleep and stress management issues. This study contributes valuable insights into Neurexan's potential benefits for individuals with short-term insomnia.
- Conditions
- Insomnia, Stress Reaction
- Being tested
- Neurexan, Placebo
- Keywords
- Polysomnography, Electroencephalogram, Sleep Efficiency, Acute Insomnia, Stress dysregulation, Hyperarousal
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeurexanDrug
The active ingredients are Passiflora incarnata Dil. D2 (0.6 mg / tablet), Avena sativa Dil. D2 (0.6 mg / tablet), Coffea arabica Dil. D12 (0.6 mg/tablet) and Zincum isovalerianicum Dil. D4 (0.6 mg / tablet). Inactive excipients are lactose monohydrate and magnesium stearate.
PlaceboDrug
Contains lactose monohydrate, magnesium stearate and looks identical to Neurexan in terms of taste, size, color and labelling.
| Study group | Role | What they receive |
|---|---|---|
| Neurexan | Experimental | Two tablets taken sublingually 3 times daily for a period of 14 consecutive days, at approximately midday, evening and bedtime and not to be taken with meals. Receives: Drug: Neurexan |
| Placebo | Placebo comparator | Two tablets taken sublingually 3 times daily for a period of 14 consecutive days as for Neurexan Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Sleep Efficiency.
Sleep Efficiency (SE) assessed using Polysomnography (PSG) is calculated as the ratio of total sleep time to time in bed (i.e., both sleeping and attempting to fall asleep or fall back asleep). SE will be assessed at baseline prior to treatment with investigational drug, then again 14 days later following investigational drug treatment.
Measured: 14 days
Secondary outcomes (3)
Change from baseline in sleep pattern characterized by Number of Awakenings.
Sleep pattern characterized by Number of Awakenings (NWAK) will be assessed using Polysomnography (PSG) at baseline prior to treatment with investigational drug, then again 14 days later following investigational drug treatment.
Measured: 14 days
Change from baseline in daytime performance assessed by Epworth Sleepiness Scale patient questionnaire.
The Epworth Sleepiness Scale (ESS) is a validated measure of a patient's general level of daytime sleepiness. The patient rates their tendency to become sleepy in 8 different situations commonly encountered in daily life, on a scale of 0 (no chance of dozing) to 3 (high chance of dozing). The total ESS score is the sum of each of the 8 scores, with a total score of 0 to 24. The higher the score, the higher the patient's level of daytime sleepiness. A number in the 0-9 range is considered to be normal, whereas a number in the range of 10-24 indicates that expert medical advice should be sought. The ESS will be completed electronically at baseline prior to treatment with investigational drug, then again 14 days later following investigational drug treatment.
Measured: 14 days
Ecological Momentary Assessments - continuous daily stress assessment.
Patients' perceived stress levels (Ecological Momentary Assessments - EMAs) will be reported electronically at the Screening Visit prior to randomization and treatment with investigational drug, then daily throughout the trial until the Day 28 Follow-up Visit. The questionnaire records levels of stress on a scale of 0 (Not stressed at all) to 10 (Very stressed), as well as the severity of stress (0 - Not severe to 10 - Very severe), how well the patient is managing the stress (0 - Not well to 10 - Very well) and the cause(s) of the stress. No sum score will be calculated.
Measured: 36 to 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start6 Sep 2023
- Primary completion31 Jan 2026
- Study completion16 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, active- and placebo-controlled confirmatory clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biologische Heilmittel Heel GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06278077
- Sponsor's protocol ID
- C2104
- Other IDs
- 2024-514391-41-00
- Acronym
- NEUREXAN SLEEP
- Status last verified
- Feb 2026
- First submitted
- 19 Feb 2024
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Doering BK, Wegner A, Hadamitzky M, Engler H, Rief W, Schedlowski M. Effects of Neurexan (R) in an experimental acute stress setting--An explorative double-blind study in healthy volunteers. Life Sci. 2016 Feb 1;146:139-47. doi: 10.1016/j.lfs.2015.12.058. Epub 2016 Jan 7.
PubMed 26772822Herrmann L, Vicheva P, Kasties V, Danyeli LV, Szycik GR, Denzel D, Fan Y, Meer JV, Vester JC, Eskoetter H, Schultz M, Walter M. fMRI Revealed Reduced Amygdala Activation after Nx4 in Mildly to Moderately Stressed Healthy Volunteers in a Randomized, Placebo-Controlled, Cross-Over Trial. Sci Rep. 2020 Mar 2;10(1):3802. doi: 10.1038/s41598-020-60392-w.
PubMed 32123197Waldschutz R, Klein P. The homeopathic preparation Neurexan vs. valerian for the treatment of insomnia: an observational study. ScientificWorldJournal. 2008 Apr 20;8:411-20. doi: 10.1100/tsw.2008.61.
PubMed 18454251Dimpfel, W. Effects of Neurexan on Stress-Induced Changes of Spectral EEG Power: A Double-Blind, Randomized, Placebo-Controlled, Crossover Exploratory Trial in Human Volunteers. World Journal of Neuroscience. 2019; 9(3): 100-112.
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06278077
- Acronym / sponsor ID
- NEUREXAN SLEEP / C2104
- Conditions
- Insomnia, Stress Reaction
- Keywords
- Polysomnography, Electroencephalogram, Sleep Efficiency, Acute Insomnia, Stress dysregulation, Hyperarousal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Biologische Heilmittel Heel GmbHIndustry (pharma, biotech, devices)
- Study start
- 6 Sep 2023 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 16 Feb 2026 (actual)
- First posted
- 26 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical study aims to understand the effects of a medication called Neurexan on sleep patterns and stress in people with short-term insomnia. The study involves comparing Neurexan to a placebo - a tablet that looks like Neurexan but lacks active ingredients. The main goal of the study is to determine if Neurexan can enhance sleep efficiency in those with short-term insomnia. Sleep efficiency, which is the proportion of time spent asleep in relation to total time in bed, including attempts to fall asleep, will be assessed through Polysomnography (PSG). PSG examines various sleep characteristics such as brain activity, muscle and heart activity, and breathing.
Participants will take either Neurexan or the placebo for 14 days. Sleep efficiency will be evaluated using PSG before and after the treatment period. Additionally, sleep quality-related factors will be investigated using PSG data, sleep diaries, and participant-completed questionnaires.
The study will also investigate Neurexan's impact on stress levels. This will be assessed using the Cold Pressor Test, which measures stress through having the participant immerse their hand into ice water, and measuring changes in blood pressure and heart rate, both indicators of stress. In addition, blood and saliva samples collected before and after treatment with Neurexan or placebo, will be analyzed for stress-related hormones such as cortisol. Patient questionnaires and Electroencephalography (EEG), a non-invasive brain activity recording, will further assess stress symptoms.
Researchers will analyze data related to sleep efficiency, sleep quality, and stress symptoms. By comparing outcomes before and after Neurexan or placebo treatment, the study aims to detect improvements in these areas. Positive results with Neurexan but not with the placebo would provide robust evidence for Neurexan's efficacy in addressing sleep and stress management issues. This study contributes valuable insights into Neurexan's potential benefits for individuals with short-term insomnia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blind, active- and placebo-controlled confirmatory clinical trial
| Arm | Type | Receives |
|---|---|---|
| Neurexan | Experimental | Drug: NeurexanTwo tablets taken sublingually 3 times daily for a period of 14 consecutive days, at approximately midday, evening and bedtime and not to be taken with meals. |
| Placebo | Placebo comparator | Drug: PlaceboTwo tablets taken sublingually 3 times daily for a period of 14 consecutive days as for Neurexan |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (24 listed)
- Patients with insomnia symptoms present longer than 90 days 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).
- Rotating shift work with overnight shifts.
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeurexanThe active ingredients are Passiflora incarnata Dil. D2 (0.6 mg / tablet), Avena sativa Dil. D2 (0.6 mg / tablet), Coffea arabica Dil. D12 (0.6 mg/tablet) and Zincum isovalerianicum Dil. D4 (0.6 mg / tablet). Inactive excipients are lactose monohydrate and magnesium stearate. | Drug | Neurexan |
| PlaceboContains lactose monohydrate, magnesium stearate and looks identical to Neurexan in terms of taste, size, color and labelling. | Drug | Placebo |
Primary outcome
Change from baseline in Sleep Efficiency.
Time frame: 14 days
Sleep Efficiency (SE) assessed using Polysomnography (PSG) is calculated as the ratio of total sleep time to time in bed (i.e., both sleeping and attempting to fall asleep or fall back asleep). SE will be assessed at baseline prior to treatment with investigational drug, then again 14 days later following investigational drug treatment.
3 secondary outcomes
Change from baseline in sleep pattern characterized by Number of Awakenings.
Time frame: 14 days
Change from baseline in daytime performance assessed by Epworth Sleepiness Scale patient questionnaire.
Time frame: 14 days
Ecological Momentary Assessments - continuous daily stress assessment.
Time frame: 36 to 56 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Background: PubMed 26772822Doering BK, Wegner A, Hadamitzky M, Engler H, Rief W, Schedlowski M. Effects of Neurexan (R) in an experimental acute stress setting--An explorative double-blind study in healthy volunteers. Life Sci. 2016 Feb 1;146:139-47. doi: 10.1016/j.lfs.2015.12.058. Epub 2016 Jan 7.
- Background: PubMed 32123197Herrmann L, Vicheva P, Kasties V, Danyeli LV, Szycik GR, Denzel D, Fan Y, Meer JV, Vester JC, Eskoetter H, Schultz M, Walter M. fMRI Revealed Reduced Amygdala Activation after Nx4 in Mildly to Moderately Stressed Healthy Volunteers in a Randomized, Placebo-Controlled, Cross-Over Trial. Sci Rep. 2020 Mar 2;10(1):3802. doi: 10.1038/s41598-020-60392-w.
- Background: PubMed 18454251Waldschutz R, Klein P. The homeopathic preparation Neurexan vs. valerian for the treatment of insomnia: an observational study. ScientificWorldJournal. 2008 Apr 20;8:411-20. doi: 10.1100/tsw.2008.61.
- BackgroundDimpfel, W. Effects of Neurexan on Stress-Induced Changes of Spectral EEG Power: A Double-Blind, Randomized, Placebo-Controlled, Crossover Exploratory Trial in Human Volunteers. World Journal of Neuroscience. 2019; 9(3): 100-112.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Neurexan in people with Insomnia and Stress Reaction, run by Biologische Heilmittel Heel GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Sleep Efficiency. (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06278077, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.