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AmaNtadine for NeuroenhancEment in acutE patients Study - A prospective pilot proof of concept phase IIb study in intensive and intermediate care unit patients (ANNES)

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-512333-33-00
Acronym
2021-10
Enrollment
50
Registered
2024-03-06
Start date
2023-03-21
Completion date
2025-12-04
Last updated
2024-08-22

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

Conditions

unresponsive wakefulness syndrome not otherwise explained

Brief summary

A patient will bedefined as a responder if he/she improves by at least 3 points on the GCS after 5 days oftreatment at study visit 6

Detailed description

The secondary objective is Improvement of vigilance measured via alternative scales(Richmond Agitation-Sedation Scale (RASS), Full Outline of UnResponsiveness(FOUR) Score Coma Scale), Intensive Care Delirium Screening Checklist (ICDSC),National Institute of health Stroke Scale (NIHSS), modified Rankin Scale (mRS),Glasgow Outcome Scale – Extended (GOS-E), Coma Recovery Scale revised (CRSR)and Montreal Cognitive Assessment (MoCA) after 90 days, EEG results, survivaland clinical improvement r

Interventions

DRUGAmantadin-ratiopharm® 200 mg Infusionslösung

Sponsors

Universitaetsklinikum Tuebingen AöR
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
A patient will bedefined as a responder if he/she improves by at least 3 points on the GCS after 5 days oftreatment at study visit 6

Secondary

MeasureTime frame
The secondary objective is Improvement of vigilance measured via alternative scales(Richmond Agitation-Sedation Scale (RASS), Full Outline of UnResponsiveness(FOUR) Score Coma Scale), Intensive Care Delirium Screening Checklist (ICDSC),National Institute of health Stroke Scale (NIHSS), modified Rankin Scale (mRS),Glasgow Outcome Scale – Extended (GOS-E), Coma Recovery Scale revised (CRSR)and Montreal Cognitive Assessment (MoCA) after 90 days, EEG results, survivaland clinical improvement r

Countries

Germany

Outcome results

None listed

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