Navigation Brain Stimulation for Evaluation of the Neuroprotective Drug Efficiency in Patients After Ischemic Stroke.

What Was Tested

In this phase 3 trial, researchers set out to test Cerebrolysin.

Ischemic stroke (IS) causes high mortality and severe disability.

It had three arms (groups): cerebrolysin (active comparator), L-Alpha glycerylphosphorylcholine (active comparator) and citicoline (active comparator).

IV.

IV.

IV and per os.

The registry classes the interventions as drug.

Who Took Part

30 planned participants were the target.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Patients from 3 to 6 months after ischemic stroke. Paresis from 2 to 4 scores by Medical Research Council Weakness Scale (MRC).

The full record lists 3 inclusion and 10 exclusion criteria; among the exclusions: history of seizures; pregnancy, lactation; cognitive deficiency (poor compliance).

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Because people in this Cerebrolysin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Cerebrolysin group and the comparison group ran side by side rather than switching.

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

It started in 2011-01 with completion listed for 2011-10.

It ran at 1 site in Russia.

Its stated primary purpose is diagnostic.

What Was Measured

Primary outcome: MEP(motor evoked potential) parameter: motor threshold (time frame: 2 months). MEP(motor evoked potential) parameter: latency (time frame: 2 months). MEP(motor evoked potential) parameter: amplitude (time frame: 2 months).

It also tracked 9 secondary outcomes, for example Medical Research Council (MRC) Scale for Muscle Strength scores, Barthel index, Modified Rankin Scale (mRS), Number of Participants with Adverse Events, Change from Baseline in Alpha waves percentage and Change from Baseline in Beta waves percentage.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Cerebrolysin in 30 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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