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

Phase 1

• Conditions: Coma and other disorders of consciousness due to acute traumatic and non-traumatic brain injury; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: CTIS2023-503617-30-02
• Lead Sponsor: Rigshospitalet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-05
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 384

Inclusion Criteria

Clinically unresponsive patients admitted to the ICU either with a traumatic or non-traumatic brain injury or a systemic medical or surgical condition causing non-medically induced coma, Unconsciousness is expected by the attending physicians to last for =3 days, Age =18 years

Exclusion Criteria

Continuous pharmacologically sedation, Expected survival <7 days, Lack of Danish or English language proficiency, Lack of next-of-kin consent, Residency outside of Denmark, Pregnancy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To do a dose escalation study to establish the safety of utilizing apomorphine and psilocybin in unresponsive ICU pa-tients with acute brain injury.;Secondary Objective: To investigate for somatic and neuropsychiatric adverse events;Primary end point(s): Time to awakening within 30 days (overall safety)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Pupillary function (pupillometry, including spontaneous pupillary function and during a mental arithmetic paradigm);Secondary end point(s):Neurovascular coupling (NIRS-EEG, including spontaneous cortical activity and activation during a tongue motor imagery paradigm) at days 1 and 7;Secondary end point(s):Clinical outcome at day 90 (GOS-E);Secondary end point(s):Days alive outside the ICU;Secondary end point(s):Serious adverse reactions (SARs), somatic and neuropsychiatric;Secondary end point(s):Serious adverse events, somatic and neuropsychiatric