Ketogenic Diet vs ACTH for the Treatment of Children With West Syndrome

What Was Tested

This registered phase 2, phase 3 trial tested ACTH (Corticotropin).

Children with West syndrome are prone to refractory seizures with poor neurocognitive outcome overall.

The current standard of care consists of treatment with ACTH, but the grade of evidence is not high and not much RCTs are available.

It had two arms (groups): Ketogenic diet arm (experimental) and ACTH arm (active comparator).

The registry classes the interventions as dietary supplement and drug.

More on the Plan

Those who respond to Vitamin trial will be excluded from the study. * Written informed consent will be taken from legal guardians who are willing to participate in the study.

Their anti-epileptic drugs will be optimised.

Who Took Part

The registry lists 80 planned participants were the target.

It was open to people of any sex aged from 6 months up to 2 years.

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

Examples of who could join: Children, aged 6 month - 2 years with electroclinical diagnosis of west syndrome.

The full record lists 1 inclusion and 5 exclusion criteria; among the exclusions: already on acth, prednisolone vigabatrin or kd therapy \> 5days; tuberous sclerosis; vitamin trial responsiveness.

How the Study Was Run

Design: randomized, parallel-group and open-label.

The participants were allocated by chance, so the ACTH (Corticotropin) group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Everyone knew when ACTH (Corticotropin) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2022-04-18 with completion listed for 2024-07.

It ran at 2 sites in India (2).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 7 secondary outcomes, for example To compare complete spasm cessation rate in KD arm vs ACTH arm, To compare electroclinical spasm To compare electroclinical spasm cessation rate in KD arm vs ACTH arm at 6 weeks, To compare sustained electroclinical cessation rate in KD arm vs ACTH arm at 3 months, To compare the compliance rate in KD arm vs ACTH arm at 6 weeks, To compare the adverse effect profile in KD arm vs ACTH arm at 6 weeks and 3 months and To compare neurodevelopmental outcome in KD arm vs ACTH arm using DASII at 3 months.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of ACTH (Corticotropin) in 80 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the ACTH (Corticotropin) compound page, all human trials.