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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) An Exploratory, Placebo-Controlled Trial in Short-Term Insomnia Patients

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-514391-41-00
Acronym
C2104
Enrollment
80
Registered
2024-08-07
Start date
2023-06-16
Completion date
Unknown
Last updated
2025-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Short-Term Insomnia

Brief summary

The primary endpoint of this trial is to assess Neurexan® related changes in SE at Visit 2 compared to Baseline 2 as revealed by polysomnography (PSG).

Detailed description

Sleep Pattern by • Further objective sleep parameters revealed by polysomnography (PSG) to be assessed as change at Visit 2 compared to Baseline 2 • Objective in-home assessment of sleep pattern revealed by actigraphy (24/7) • Subjective sleep pattern assessed using sleep questionnaires and sleep diary (adapted from Deutsche Gesellschaft für Schlafforschung und Schlafmedizin, DGSM), to be recorded on AMS-ePRO® Daytime Performance by • Resting state EEG; Stress Processing; Blood sampling

Interventions

DRUGNeurexan Tabletten
DRUGPlacebo to Neurexan Tablet

Sponsors

Biologische Heilmittel Heel GmbH
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
The primary endpoint of this trial is to assess Neurexan® related changes in SE at Visit 2 compared to Baseline 2 as revealed by polysomnography (PSG).—

Secondary

MeasureTime frame
Sleep Pattern by • Further objective sleep parameters revealed by polysomnography (PSG) to be assessed as change at Visit 2 compared to Baseline 2 • Objective in-home assessment of sleep pattern revealed by actigraphy (24/7) • Subjective sleep pattern assessed using sleep questionnaires and sleep diary (adapted from Deutsche Gesellschaft für Schlafforschung und Schlafmedizin, DGSM), to be recorded on AMS-ePRO® Daytime Performance by • Resting state EEG; Stress Processing; Blood sampling—

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026