Efficacy of Prednisolone Versus Cerebrolysin in the Treatment of Bell's Palsy

What Was Tested

This registered phase 1, phase 2 trial tested Cerebrolysin for bell's palsy.

Bell's palsy, a peripheral facial nerve paresis, is the most common disorder of the facial nerve and one of the most common mononeuropathies.

It had three arms (groups): Prednisolone (active comparator), Cerebrolysin (active comparator) and Prednisolone and Cerebrolysin (active comparator).

The registry classes the interventions as drug.

Who Took Part

90 planned participants were the target.

It was open to people of any sex aged from 18 years up to 60 years.

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

Examples of who could join: Unilateral acute facial palsy of no identifiable cause.

The full record lists 1 inclusion and 11 exclusion criteria; among the exclusions: recurrent facial bell's palsy; severe hypertension,; renal or hepatic disease,.

How the Study Was Run

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

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

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: investigator and outcomes assessor.

It started in 2023-08-24 with completion listed for 2026-01.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: change in scores of the house Brackman grading system HB (time frame: at baseline, after 1 week, after 3 week). changes in scores of the Sunnybrook grading system (time frame: at baseline, after 1 week, after 3 week).

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of Cerebrolysin in 90 people with bell's palsy.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cerebrolysin compound page, Bell's palsy research.