Boosting recovery through excitation of arousal and awareness in comatose patients (BREA2KTHROUGH)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Rigshospitalet

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Decision date (initial)

2023-11-20

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy, Safety

To investigate if psilocybin and apomorphine can improve clinical levels of consciousness (as measured by the FOUR score and the SECONDs)

Secondary objectives 1

1. To investigate if psilocybin and apomorphine can improve proxy biomarkers of consciousness (as measured by NIRS-EEG and pupillometry)

Conditions and MedDRA coding

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

Regulatory references

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. 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
2. Unconsciousness is expected by the attending physicians to last for ≥3 days
3. Age ≥18 years

Exclusion criteria 6

1. Continuous pharmacologically sedation
2. Expected survival <7 days
3. Lack of Danish or English language proficiency
4. Lack of next-of-kin consent
5. Residency outside of Denmark
6. Pregnancy

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Co-primary outcomes 1: Number of patients with improved consciousness within 3-6h after a single dose of oral psilocybin with/without apomorphine vs. placebo (as measured by a composite score of either FOUR score ≥2 and/or SECONDs ≥1
2. Co-primary outcome 2: Number of patients with improved consciousness levels within 3-6h after oral psilocybin/apomorphine vs. psilocy-bin/placebo

Secondary endpoints 6

1. Pupillary function (pupillometry, including spontaneous pupillary function and during a mental arithmetic paradigm)
2. Neurovascular coupling (NIRS-EEG, including spontaneous cortical activity and activation during a tongue motor imagery paradigm) at days 1 and 7
3. Clinical outcome at day 90 (GOS-E)
4. Days alive outside the ICU
5. Serious adverse reactions (SARs)
6. Serious adverse events

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Rigshospitalet

Sponsor organisation

Rigshospitalet

Address

Blegdamsvej 9

City

Copenhagen Oe

Postcode

2100

Country

Denmark

Scientific contact point

Organisation

Rigshospitalet

Contact name

Daniel Kondziella

Public contact point

Organisation

Rigshospitalet

Contact name

Daniel Kondziella

Third parties 1

Locations

1 EU/EEA country · 3 investigational sites

By country

Investigational sites

Application history

1 submissions — initial application plus substantial / non-substantial modifications