Efficacy and safety of Cerebrolysin for neurorecovery after moderate-severe traumatic brain injury

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Foundation For The Study Of Nanoneuroscience And Neuroregeneration

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

27 Aug 2024 → ongoing

Decision date (initial)

2024-08-27

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-515591-12-00

EudraCT number

2022-003382-38

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

To assess Glasgow Outcome Scale Extended (GOSE) outcomes at 90 days after baseline

Secondary objectives 1

1. To assess the efficacy of Cerebrolysin versus Placebo upon neurological deficit, functional outcome, symptoms of anxiety and depression, drug safety and quality of life 10, 45, 90 and 180 days after baseline

Conditions and MedDRA coding

Traumatic brain injury

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. ● Diagnosis of TBI and a GCS score of 7-12 (best available score in 24h after hospital admission). Pre-hospital intubation/sedation/paralysis is accepted if the GCS score has been assessed before intubation/sedation/paralysis by trained personnel. ● A pre-treatment GCS score of 7-12. If intubation/sedation/paralysis occurs after hospital admission, the pre-treatment GCS score has been assessed before intubation/sedation/paralysis. ● Isolated TBI only (abbreviated injury score (AIS) in other body regions of ≤2) ● CT (Marshal classification) I to VI (from diffuse injury to non-evacuated mass lesion) ● Pre-Trauma Karnofsky Index = 100. If no corresponding information is available before the start of treatment (e.g., the patient is unconscious or not able to communicate) and no information is retrieved within 24 hours after the start of treatment, the patient stays in the study. If no information is available before the start of treatment and a violation of the Karnofsky Index is detected within 24 hours after the start of treatment, the patient is withdrawn from the study, and the treatment medication is stopped. ● Aged 18-85 years ● Able to provide written informed consent to enrollment ● Willing and able to comply with the protocol requirements for the duration of the study ● Women of child-bearing potential with a negative urine pregnancy test who are willing to practice an acceptable method of birth control ● Time to needle for study medication should be within 4 hours ● Patients were able to speak, read and write before the accident. If no corresponding information is available before the start of treatment (e.g., the patient is unconscious or not able to communicate) and if no information is retrieved within 24 hours after the start of treatment, the patient should remain in the study. If no information is available before the start of treatment and if a violation of this inclusion criterion is detected within 24 hours after the start of treatment the patient should be withdrawn from the study, and the treatment medication should be stopped.

Exclusion criteria 1

1. ● Patients with polytrauma (AIS score in other body regions of >2) ● Patients with spinal cord injury ● History of intracranial intervention or hemorrhagic stroke ● Patients who had an ischemic stroke in the 12 months prior to the traumatic brain injury ● Existence of neurodegenerative diseases ● Patients who in the investigator’s opinion would not comply with study procedures ● Patients with a history of epileptic seizure ● Use of concomitant neuroprotective treatment or cholinesterase inhibitors for previous cognitive treatment ● Persons who are under chronic treatment (>6 months) with cortisone, Ca+-channel blockers, antidepressants, antipsychotic drugs or nootropic molecules ● Significant or unstable medical, systemic or logistical condition that affects the subject’s ability to give informed consent or to complete the study procedures

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Glasgow Outcome Scale Extended (GOSE) outcome at 90 days after baseline

Secondary endpoints 1

1. efficacy of Cerebrolysin versus Placebo upon neurological deficit, functional outcome, symptoms of anxiety and depression, drug safety and quality of life 10,45, 90 and 180 days after baseline.

Investigational products

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

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Foundation For The Study Of Nanoneuroscience And Neuroregeneration

Sponsor organisation

Foundation For The Study Of Nanoneuroscience And Neuroregeneration

Address

Strada Eliade Mircea No 37

City

Cluj-Napoca

Postcode

400354

Country

Romania

Scientific contact point

Organisation

Foundation For The Study Of Nanoneuroscience And Neuroregeneration

Contact name

Clinical Trial information desk

Public contact point

Organisation

Foundation For The Study Of Nanoneuroscience And Neuroregeneration

Contact name

Clinical Trial information desk

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 5 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

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