Combined Treatment With Alteplase (Rt-PA) and Cerebrolysin® in Acute Ischemic Hemispheric Stroke

What Was Tested

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

It had two arms (groups): Cerebrolysin (experimental) and one (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Due to the initial findings special emphasis will be also put on analysing the speed of recovery.

Who Took Part

119 actual participants took part.

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: Female or male inpatients. Age: 18-80 years. If female, patient must not be pregnant. Onset of symptoms within 3 hours prior to initiation of rt-PA administration. Willingness and ability to comply with the protocol.

The full record lists 9 inclusion and 37 exclusion criteria; among the exclusions: evidence of intracranial haemorrhage (ich) on the ct-scan; violation of inclusion criteria not approved by clinical study director or study safety officer; failure to perform or to evaluate screening or baseline examinations.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

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.

As a double-blind Cerebrolysin study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2005-10 with completion listed for 2008-03.

It ran at 15 sites in Austria (5), Croatia (4), Czechia (4), Slovakia (1) and Slovenia (1).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Modified Rankin Scale score at day 90 (or earlier in the event of patient withdrawal) (time frame: Day 90).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Cerebrolysin in 119 people.

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.