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← Back to the studies fieldPERMANENT CTIS TRIAL DOSSIER

2023-503617-30-02

Boosting recovery through excitation of arousal and awareness in comatose patients: Dose finding study (BREA2KTHROUGH DOSEFINDER)

Public registry stateAuthorised
CLAIM BOUNDARY

This dossier documents a medicinal trial—not proof of efficacy.

Registration, authorisation of a trial application, trial start, result disclosure and marketing authorisation are different facts. The dossier claims neither clinical efficacy nor safety, deployment or causality.

CTIS record ≠ efficacy ≠ marketing authorisation
REGISTRY FACTS

What CTIS publishes about this trial

EUCT number
2023-503617-30-02
Trial status
Authorised
Sponsor
not published
Trial region
EEA
Phase
3
Trial category
2
Low-intervention trial
no
Estimated EU start
26 February 2025
Decision date
28 May 2024
Published
12 June 2026
Estimated end
31 December 2028
EXACT AI EVIDENCE

The original text determines inclusion.

Terms count only in allowlisted public CTIS fields. Sponsor, medical condition, phase or a generic software reference alone is not AI evidence.

“Neurovascular coupling (NIRS-EEG) measures combined with EEG features from our machine learning algorithm following administration of psylocibin and apomorphine, and cortical activation during tongue mental imagery paradigm (exploratory endpoint)”
Source field
authorizedApplication.authorizedPartI.trialDetails.trialInformation.endPoint.secondaryEndPoints[5].endPoint
Matched term
machine learning
MEDICAL CONTEXT

Conditions and therapeutic areas

Reported medical conditions

  • Coma and other disorders of consciousness due to acute traumatic and non-traumatic brain injury

Therapeutic areas

  • Diseases [C] - Nervous System Diseases [C10]10
COUNTRY TRACKS

Every country retains its own published state.

A status in one country is not transferred to another. Decision dates and status histories remain separate source facts.

Denmark

Authorised
First decision
28 May 2024
Latest decision
27 February 2025
  1. Authorised
  2. Authorised
  3. Authorised
  4. Authorised
  5. Authorised
  6. Authorised
  7. Authorised
  8. Authorised
  9. Authorised
TRIAL APPLICATIONS

Submission, decision and country state remain separate

IN-2

INITIAL

Authorised
Trial status
Authorised
Submitted
05 December 2023
Decided
28 May 2024

Decisions28 May 2024 · Authorized

Country statusDenmark · Authorised

SM-1

SUBSTANTIAL MODIFICATION

Authorised
Trial status
Authorised
Submitted
12 July 2024
Decided
31 July 2024

Decisions31 July 2024 · Authorized

NSM-1

NON SUBSTANTIAL MODIFICATION

Authorised
Trial status
Authorised
Submitted
04 December 2024
Decided
04 December 2024

Decisions04 December 2024 · Authorized

SM-2

SUBSTANTIAL MODIFICATION

Authorised
Trial status
Authorised
Submitted
10 December 2024
Decided
18 December 2024

Decisions18 December 2024 · Authorized

SM-4

SUBSTANTIAL MODIFICATION

Authorised
Trial status
Authorised
Submitted
23 January 2025
Decided
27 February 2025

Decisions27 February 2025 · Authorized

Country statusDenmark · Authorised

SM-5

SUBSTANTIAL MODIFICATION

Not Authorised
Trial status
Authorised
Submitted
12 April 2025
Decided
not published

Country statusDenmark · Authorised

NSM-4

NON SUBSTANTIAL MODIFICATION

Authorised
Trial status
Authorised
Submitted
11 June 2026
Decided
11 June 2026

Decisions11 June 2026 · Authorized

SOURCE-DATED CHRONICLE

Official dates, not an efficacy narrative.

The chronicle sorts published CTIS events. i6eal observation times follow on a separate clock.

  1. Application Submitted

    Application IN-2 · Authorised

  2. Country Assessment

    Denmark · Application IN-2 · Authorized

  3. Application Status

    Application IN-2 · Authorised

  4. Country Decision

    Denmark · Application IN-2 · Authorized

  5. Application Submitted

    Application SM-1 · Authorised

  6. Application Status

    Application SM-1 · Authorised

  7. Country Decision

    Denmark · Application SM-1 · Authorized

  8. Application Status

    Application NSM-1 · Authorised

  9. Application Submitted

    Application NSM-1 · Authorised

  10. Country Decision

    Denmark · Application NSM-1 · Authorized

  11. Application Submitted

    Application SM-2 · Authorised

  12. Application Status

    Application SM-2 · Authorised

  13. Country Decision

    Denmark · Application SM-2 · Authorized

  14. Application Submitted

    Application SM-4 · Authorised

  15. Country Assessment

    Denmark · Application SM-4 · Authorized

  16. Application Status

    Application SM-4 · Authorised

  17. Country Decision

    Denmark · Application SM-4 · Authorized

  18. Application Submitted

    Application SM-5 · Authorised

  19. Country Assessment

    Denmark · Application SM-5 · Authorized

  20. Application Status

    Application NSM-4 · Authorised

  21. Application Submitted

    Application NSM-4 · Authorised

  22. Country Decision

    Denmark · Application NSM-4 · Authorized

  23. Trial Status Observed

    Authorised

Observed by i6eal
First observed
23 Jul 2026, 13:19
Last observed
23 Jul 2026, 15:03
Materially modified
23 July 2026
RESULT DISCLOSURE

Disclosure is a separate registry fact.

No result disclosure is published in this projection. This means neither that results do not exist nor that a deadline has been missed.

PROVENANCE

From the dossier back to the official record

The public CTIS record remains authoritative. The i6eal files are a deterministic, bounded projection.

Open public CTIS record ↗Open CTIS retrieval source ↗Machine-readable dossier · JSON ↓Structured metadata · JSON-LD ↓
i6eal (2026): EU AI Studies Monitor, CTIS trial 2023-503617-30-02, data state 23 July 2026. https://i6eal.de/en/tools/ki-studienmonitor/studie/2023-503617-30-02/
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