the Effect of Cerebrolysin on Physical and Mental Functions of Down Syndrome

What Was Tested

This registered phase 2 trial tested Cerebrolysin.

Down syndrome is a genetic disorder that causes delay in both physical growth and mental development.

It is the most frequently reported chromosomal abnormality and the most common genetic syndrome.

Down syndrome is caused by trisomy of all or part of the genetic material of human chromosome 21.

It had two arms (groups): Intervention Arm (active comparator) and Non-intervention Arm (no intervention).

No medication was given.

The registry classes the interventions as drug.

Who Took Part

The registry lists 64 actual participants took part.

It was open to people of any sex aged from 6 months up to 7 months.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Infants were confirmed to have Down syndrome of non disjunction genotype. Age was around 6 month, at time of recruitment. Legal guardians accepted to participate in the study and sign the informed consent.

The full record lists 3 inclusion and 5 exclusion criteria; among the exclusions: patients having uncontrolled hypothyroidism; patients with brain malformations other than the expected in infant with down syndrome; patients with hearing and / or vision impairments.

How the Study Was Run

Design: randomized, parallel-group and single-blind.

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.

Only one side, usually the participants, was kept unaware of whether Cerebrolysin was given.

Those kept unaware of assignments: participant.

It started in 2016-09-30 with completion listed for 2019-02-28.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Rate of neurocognitive development (time frame: Time frame: 12 month).

It also tracked 1 secondary outcome, for example Number of participants with side effects of cerebrolysin.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Cerebrolysin in 64 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.