Prednisolone plus B12 tested against prednisolone alone in infantile spasms

A prospective, open-label randomized controlled trial comparing prednisolone combined with vitamin B12 against prednisolone alone in children with infantile epileptic spasms syndrome (IESS) was published online on 10 October 2026 in Seizure: European Journal of Epilepsy.

The study comes from Vykuntaraju K. Gowda, Deepthi Balachandradhara, Sanjay K. Shivanna, and Ashwini Karanam. The authors designed the trial as open-label: clinicians and families knew which arm each child received, while outcome assessment followed a prospective randomized protocol.

Why does this trial matter for the reading room?

Infantile epileptic spasms syndrome remains one of the most treatment-resistant epileptic encephalopathies of infancy. Hormonal therapy with prednisolone is an established first-line option, yet a substantial share of children fail to achieve spasm freedom, and relapse after initial response is common.

Vitamin B12 has attracted interest as an adjunct because of its role in myelination and neuronal metabolism during early brain development. Until now, evidence for adding it to standard hormonal treatment has been limited, and the trial addresses that gap directly in a randomized design.

What was compared?

The trial evaluated two treatment strategies in children diagnosed with IESS:

• Intervention arm: prednisolone combined with vitamin B12
• Control arm: prednisolone alone

The open-label design means the study measured real-world treatment effects without blinding, a common and accepted approach in pediatric drug trials where placebo arms raise ethical concerns in a condition that urgently requires effective therapy.

How should clinicians frame the evidence?

For neurophysiologists and epileptologists, the key outcome measures in IESS trials conventionally include clinical cessation of spasms and resolution of hypsarrhythmia on scalp EEG. The published report presents the comparison between the two arms on these treatment-response endpoints, and readers should consult the full publication in Seizure for the specific response rates and statistical findings.

The trial is a human study in a pediatric patient population. It is not a device or neurofeedback investigation, and no regulatory clearance question applies. Its relevance lies purely in pharmacotherapy: whether a widely available, low-cost vitamin adjunct improves outcomes over hormonal therapy alone.

What happens next?

Because the trial is open-label and single-center in authorship, replication in blinded, multi-center designs will determine whether the prednisolone–B12 combination should enter standard protocols for infantile epileptic spasms syndrome.