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Human evidence record ยท Cerebrolysin

Cerebrolysin enhances cognitive recovery of mild traumatic brain injury patients

CASI improvement from baseline to week 12 was greater with Cerebrolysin (21.0 vs 7.6; p=0.0461).

Quick read
Human evidence record

What this study tells us

Participants were assigned to comparison groups by chance, usually with placebo and/or blinding to reduce bias. This is a strong design for testing cause and effect, but the population, duration and endpoints still limit what can be concluded.

Who was studied?

Adults with acute mild TBI and intracranial contusion haemorrhage

How many?

n=32

What happened?

CASI improvement from baseline to week 12 was greater with Cerebrolysin (21.0 vs 7.6; p=0.0461).

What stops us overclaiming?

Very small N; multiple cognitive domains; borderline primary comparison; requires replication.

Need help with terms such as randomized, placebo, endpoint or sample size? Open the glossary โ†’

Key result

CASI improvement from baseline to week 12 was greater with Cerebrolysin (21.0 vs 7.6; p=0.0461).

Study details

Study designDouble-blind, placebo-controlled randomized pilot
PhasePhase 2 pilot
PopulationAdults with acute mild TBI and intracranial contusion haemorrhage
Sample size32
RouteIntravenous
Regimen / exposure30 mL daily over 60 min for 5 days
Duration5 days; follow-up to week 12
ComparatorNormal saline
Primary endpoint / questionMMSE/CASI cognitive recovery
Safety resultSmall pilot reported no major safety signal highlighted in abstract.
Key limitationsVery small N; multiple cognitive domains; borderline primary comparison; requires replication.
Registry / identifierPMID 23656173