Denmark
Authorised- First decision
- 28 May 2024
- Latest decision
- 27 February 2025
- Authorised
- Authorised
- Authorised
- Authorised
- Authorised
- Authorised
- Authorised
- Authorised
- Authorised
- Authorised
← 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 authorisationREGISTRY FACTS
What CTIS publishes about this trial
- EUCT number
- 2023-503617-30-02
- Trial status
- Authorised
- Sponsor
- not published
- Trial region
- EEA
- CTIS phase code
- 3
- CTIS category code
- 2
- Low-intervention trial
- no
- Estimated EU start
- 26 February 2025
- Decision date
- 28 May 2024
- Published
- 14 August 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.
No public AI text excerpt is published for this dossier.
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.
TRIAL APPLICATIONS
Submission, decision and country state remain separate
IN-2
AuthorisedINITIAL
- Trial status
- Authorised
- Submitted
- 05 December 2023
- Decided
- 28 May 2024
Decisions28 May 2024 · Authorized
Country statusDenmark · Authorised
SM-1
AuthorisedSUBSTANTIAL MODIFICATION
- Trial status
- Authorised
- Submitted
- 12 July 2024
- Decided
- 31 July 2024
Decisions31 July 2024 · Authorized
NSM-1
AuthorisedNON SUBSTANTIAL MODIFICATION
- Trial status
- Authorised
- Submitted
- 04 December 2024
- Decided
- 04 December 2024
Decisions04 December 2024 · Authorized
SM-2
AuthorisedSUBSTANTIAL MODIFICATION
- Trial status
- Authorised
- Submitted
- 10 December 2024
- Decided
- 18 December 2024
Decisions18 December 2024 · Authorized
SM-4
AuthorisedSUBSTANTIAL MODIFICATION
- Trial status
- Authorised
- Submitted
- 23 January 2025
- Decided
- 27 February 2025
Decisions27 February 2025 · Authorized
Country statusDenmark · Authorised
SM-5
Not AuthorisedSUBSTANTIAL MODIFICATION
- Trial status
- Authorised
- Submitted
- 12 April 2025
- Decided
- not published
Country statusDenmark · Authorised
NSM-4
AuthorisedNON SUBSTANTIAL MODIFICATION
- Trial status
- Authorised
- Submitted
- 11 June 2026
- Decided
- 11 June 2026
Decisions11 June 2026 · Authorized
NSM-5
AuthorisedNON SUBSTANTIAL MODIFICATION
- Trial status
- Authorised
- Submitted
- 13 August 2026
- Decided
- 13 August 2026
Decisions14 August 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.
Application Submitted Application IN-2 · Authorised
Country Assessment Denmark · Application IN-2 · Authorized
Application Status Application IN-2 · Authorised
Country Decision Denmark · Application IN-2 · Authorized
Application Submitted Application SM-1 · Authorised
Application Status Application SM-1 · Authorised
Country Decision Denmark · Application SM-1 · Authorized
Application Status Application NSM-1 · Authorised
Application Submitted Application NSM-1 · Authorised
Country Decision Denmark · Application NSM-1 · Authorized
Application Submitted Application SM-2 · Authorised
Application Status Application SM-2 · Authorised
Country Decision Denmark · Application SM-2 · Authorized
Application Submitted Application SM-4 · Authorised
Country Assessment Denmark · Application SM-4 · Authorized
Application Status Application SM-4 · Authorised
Country Decision Denmark · Application SM-4 · Authorized
Application Submitted Application SM-5 · Authorised
Country Assessment Denmark · Application SM-5 · Authorized
Application Status Application NSM-4 · Authorised
Application Submitted Application NSM-4 · Authorised
Country Decision Denmark · Application NSM-4 · Authorized
Application Submitted Application NSM-5 · Authorised
Application Status Application NSM-5 · Authorised
Country Decision Denmark · Application NSM-5 · Authorized
Trial Status Observed Authorised
Observed by i6eal
- First observed
- 23 Jul 2026, 13:19
- Last observed
- 06 Sept 2026, 04:29
- Materially modified
- 25 August 2026
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 25 August 2026. https://i6eal.de/en/tools/ki-studienmonitor/studie/2023-503617-30-02/