Comprehensive Reparative Therapy in Ischemic Stroke COMplex Repair in Ischemic Stroke-Arm

What Was Tested

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

Each patient participates in the study for 176-190 days (approximately 6 months).

The estimated duration of the study is 2 years.

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

The registry classes the interventions as drug and other.

More on the Plan

Rehabilitation programs and drug therapy in a stroke aimed, primarily, to the stimulation of the processes of neuroplasticity.

After the screening procedures the eligible patients get randomized in 1 of the 2 groups: either the group of a standard therapy in combination with Cerebrolysin infusions, or the group of a standard therapy in combination with placebo infusions.

The therapy consists of the 3 consecutive periods: 1. st - 10 days of daily infusions of Cerebrolysin / placebo; 2. nd - 7 days break; 3. d - 10 days of daily infusions of Cerebrolysin / placebo.

Patients will be transferred from the 1st site to the 2nd one at the moment of time between Visit 2 and Visit 3.

Who Took Part

The registry lists 30 planned participants were the target.

It was open to people of any sex aged from 45 years up to 75 years.

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

Examples of who could join: A signed patient informed consent;. Men and women at the age from 45 years to 75 years, inclusive;. The severity of the stroke from 5 to 24 points on a scale NIHSS;. The time from the onset of the disease prior to the introduction of the drug for 72 hours;.

The full record lists 7 inclusion and 37 exclusion criteria; among the exclusions: the age of 45 years or older than 75 years;; known intolerance (including allergic reactions) cerebrolysin, excipients of the investigational medication;; thrombolytic therapy;.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

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.

Blinding on both sides kept the participants and researchers unaware of who received Cerebrolysin.

Those kept unaware of assignments: participant and investigator.

It started in 2015-02 with completion listed for 2017-02.

It ran at 2 sites in Russia (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Overall dynamics of the hand function assessed by the Frenchay Arm Test (time frame: 6 months).

It also tracked 10 secondary outcomes, for example Dynamics of the hand function assessed by the Frenchay Arm Test, Dynamics of the grades on the NIHSS scale, Dynamics of the grades on the modified Rankin scale, Dynamics of the Barthel index changes, Dynamics of the amplitude of motor responses and Dynamics of the latency of motor responses.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Cerebrolysin in 30 people.

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

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.