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Trial · Interventional

Status unknownPhase 4Registry data

CERebrolysine Effect on Blood-brain Barrier in acUte Ischemic Stroke

Short name CERBERUS

NCTNCT06078215 (opens ClinicalTrials.gov in a new tab)Other id392/2023
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Status unknown
Phase
Phase 4
Enrollment
350 participants (estimated)
Sponsor
Poznan University of Medical Sciences · Other
Design
Randomized · Open label (no masking)
Countries
1 country

Poland

Start
10 Jan 2023
Primary completion
31 Jan 2025 (estimated)
Completion
31 Mar 2025 (estimated)
First posted
11 Oct 2023
Last update posted
13 Oct 2023
Conditions
Acute Ischemic Stroke

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2023202420252026
  1. Ph 4

    CERBERUS

    NCT06078215

    10 Jan 2023 to est. 31 Mar 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The study investigates whether Cerebrolysin stabilizes blood-brain barrier integrity in a manner that can be monitored using serum levels of the principal tight junction proteins, e.g., occludin (OCL), claudin-5 (CLN), and zonula occludens-1 (ZO-1), or other molecules known to be involved in BBB degradation, e.g., S100B and whether it protects against hemorrhagic transformation in ischemic stroke patients after reperfusion therapy (i.e. thrombolysis and/or mechanical thrombectomy).

Interventions

  • CerebrolysinCombination product

Arms3

  • No intervention

    Thrombolysis and/or mechanical thrombectomy

    patients included for reperfusion therapy (intravenous thrombolysis and/or mechanical thrombectomy - comparator

  • Experimental

    Cerebrolysin

    patients included for reperfusion therapy (intravenous thrombolysis and/or mechanical thrombectomy and treated with Cerebrolysin

  • No intervention

    No reperfusion therapy / no cerebrolysin

    patients not referred to reperfusion therapy nor Cerebrolysin

Primary outcomes9

Outcomes the sponsor listed as primary.

  1. National Institute of Health Stroke Scale

    Time frame · every day for 7 days after stroke onset

    Registry description

    National Institute of Health Stroke Scale; score range: 1-42; 1-4 - Minor stroke; 5-15 - Moderate stroke; 16-20 - Moderate to severe stroke; 21-42 - Severe stroke

  2. National Institute of Health Stroke Scale

    Time frame · at day 30 after stroke onset

    Registry description

    National Institute of Health Stroke Scale; score range: 1-42; 1-4 - Minor stroke; 5-15 - Moderate stroke; 16-20 - Moderate to severe stroke; 21-42 - Severe stroke

  3. Detection of hemorrhagic transformation [range o:1]

    Time frame · within 1 to 3 days after stroke onset, after worsening of clinical status by more than 4 points in NIHSS

    Registry description

    hemorrhagic transformation on head computerized tomography

  4. Concentration of plasma occludin [ng/mL]

    Time frame · at the admission, within 1 to 3 days after stroke onset

    Registry description

    Occludin is an enzyme (EC 1.6) that oxidizes NADH (Nicotinamide adenine dinucleotide)

  5. Concentration of plasma occludin [ng/mL]

    Time frame · at 7th day after stroke onset

    Registry description

    Occludin is an enzyme (EC 1.6) that oxidizes NADH (Nicotinamide adenine dinucleotide)

  6. Concentration of plasma claudin 5 [ng/mL]

    Time frame · at the admission, within 1 to 3 days after stroke onset

    Registry description

    Claudins are small (20-24/27 kilodalton (kDa)) transmembrane proteins.

  7. Concentration of plasma claudin 5 [ng/mL]

    Time frame · at 7th day after stroke onset

    Registry description

    Claudins are small (20-24/27 kilodalton (kDa)) transmembrane proteins.

  8. Concentration of plasma ZO1 [ng/mL]

    Time frame · at the admission, within 1 to 3 days after stroke onset

    Registry description

    Zonula occludens-1 ZO-1, also known as Tight junction protein-1

  9. Concentration of plasma ZO1 [ng/mL]

    Time frame · at 7th day after stroke onset

    Registry description

    Zonula occludens-1 ZO-1, also known as Tight junction protein-1

Secondary outcomes(8)

  1. Modified Rankin scale [range 0:6]

    Time frame · at the admission, within 1 to 3 days after stroke onset

    Registry description

    Modified Rankin scale; 0-2 - good functional outcome; 3-6 - poor functional outcome

  2. Modified Rankin scale [range 0:6]

    Time frame · at 7th day after stroke onset

    Registry description

    Modified Rankin scale; 0-2 - good functional outcome; 3-6 - poor functional outcome

  3. Modified Rankin scale [range 0:6]

    Time frame · at the 30th +/- 5 day after stroke onset

    Registry description

    Modified Rankin scale; 0-2 - good functional outcome; 3-6 - poor functional outcome

  4. Modified Rankin scale [range 0:6]

    Time frame · at 90th +/- 5 day after stroke onset

    Registry description

    Modified Rankin scale; 0-2 - good functional outcome; 3-6 - poor functional outcome

  5. Barthel Index for Activities of Daily Living (ADL) [range 0:100]

    Time frame · 30th +/- 5 day after stroke onset

    Registry description

    measures the degree of assistance required by an individual; 0-20 - total dependency, 21-60 - severe dependency, 61-90 - moderate dependency, 91-100 - slight dependency

  6. Barthel Index for Activities of Daily Living (ADL) [range 0:100]

    Time frame · at the 90th +/- 5 day after stroke onset

    Registry description

    measures the degree of assistance required by an individual; 0-20 - total dependency, 21-60 - severe dependency, 61-90 - moderate dependency, 91-100 - slight dependency

  7. Death [range 0:1]

    Time frame · within 90 days after stroke onset

    Registry description

    survival measure

  8. Montreal Cognitive Assessment Test [range 0:30]

    Time frame · at the 90th +/-5 day after stroke onset

    Registry description

    the assessment of cognitive functions; 26-30 - normal cognition, 18-25 - mild cognitive impairment, 10-17 - moderate cognitive impairment, \<10 - severe cognitive impairment

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies4

Studies that cite this trial.

Studies with results

4 studies on this page

PubMed tag: none · 2021

4 results

Therapeutic effect of Cerebrolysin on reducing impaired cerebral endothelial cell permeability.

Teng et al. 2021Neuroreportcited by 32

PMID 33661804DOI 10.1097/wnr.0000000000001598PUB-33661804

Full text at the publisher4 results
Publisher pageSee results (4)

Indexing hint: Clinical trial · 2021

3 results

Efficacy and safety of Cerebrolysin after futile recanalisation therapy in patients with severe stroke.

Poljakovic et al. 2021Clinical neurology and neurosurgerycited by 22

PMID 34214867DOI 10.1016/j.clineuro.2021.106767PUB-34214867

Full text at the publisher3 results
Publisher pageSee results (3)

Indexing hint: Animal study · 2019

9 results

Cerebrolysin Reduces Astrogliosis and Axonal Injury and Enhances Neurogenesis in Rats After Closed Head Injury.

Zhang et al. 2019Neurorehabilitation and neural repaircited by 24

PMID 30499355DOI 10.1177/1545968318809916PUB-30499355

Rights unknown9 results
Source linkSee results (9)

Indexing hint: Randomized controlled trial · 2013

4 results

A prospective, randomized, placebo-controlled, double-blind trial about safety and efficacy of combined treatment with alteplase (rt-PA) and Cerebrolysin in acute ischaemic hemispheric stroke.

Lang et al. 2013International journal of stroke : official journal of the International Stroke Societycited by 72

PMID 23009193DOI 10.1111/j.1747-4949.2012.00901.xPUB-23009193

Full text at the publisher4 results
Publisher pageSee results (4)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * acute ischemic stroke patients * informed consent Exclusion Criteria: * no informed consent * primary or metastatic brain tumor * brain abscess * encephalitis * localized inflammation * sepsis * autoimmune diseases of central or peripheral nervous system * Cerebrolysin hypersensitivity / allergy * epilepsy * severe kidney disease

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