Effect of Cerebrolysin on the Blood Brain Barrier in Patients With Diabetes and Ischemic Stroke

What Was Tested

In this phase 4 trial, researchers set out to test Cerebrolysin.

José Eleuterio González" in order to analyze the effect of cerebrolysin on the blood-brain-barrier in patients with ischemic stroke with personal history of type-2 diabetes.

It had three arms (groups): Intravenous thrombolysis and cerebrolysin (experimental), Intravenous thrombolysis without cerebrolysin (active comparator) and Patients with cerebrolysin without IVT (other).

Group 2 : 20 patients with previous IVT in the qualifying stroke and who agreed to receive cerebrolysin but they were not choose through randomization.

The registry classes the interventions as drug and procedure.

More on the Plan

José Eleuterio González" in order to analyze the effect of cerebrolysin on the blood-brain-barrier (BBB) in patients with ischemic stroke (IS) of the middle cerebral artery with personal history of type-2 diabetes (T2D).

The main objective is to compare the effect of cerebrolysin on the BBB in the above mentioned patients with intravenous thrombolysis (IVT) and without IVT.

The hypothesis of this study is that cerebrolysin can affect the BBB permeability after 10 days of the administration of this drug.

Who Took Part

60 planned participants were the target.

It was open to people of any sex aged from 18 years up to 80 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age 18 - 80 years. Clinical and imaging criteria for ischemic stroke of the middle cerebral artery. Acute non-lacunar cerebral infarction. Cerebral infarction with a score on the NIH scale between 5 and 20 points. MRs ≤ 1 before the qualifying stroke (functionally independent for all activities of daily living).

The full record lists 7 inclusion and 8 exclusion criteria; among the exclusions: advanced disease or terminal with life expectancy \< 6 months; \- over 80 years old; lacunar infarction or small vessel disease.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Cerebrolysin and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label Cerebrolysin study: the participants and staff both knew the treatment.

It started in 2022-11-17 with completion listed for 2024-11.

It ran at 1 site in Mexico.

Its stated primary purpose is supportive care.

What Was Measured

Primary outcome: Blood-Brain-Barrier Permeability after 10-14days of cerebrolysin in patients with AIS of the middle cerebral artery (time frame: After 10-14 days of cerebrolysin).

It also tracked 3 secondary outcomes, for example Comparison of clinical severity, using NIH Stroke Scale in patients with and withouth cerebrolysin, Comparison of functional prognosis, using modified Rankin scale in patients with and withouth cerebrolysin and Comparison of cognitive impairment, using Montreal Cognitive Assessment in patients with and withouth cerebrolysin.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Cerebrolysin in 60 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cerebrolysin compound page, all human trials.