Cortical Excitability in West Syndrome Using Transcranial Magnetic Stimulation

What Was Tested

In this phase 2, phase 3 trial, researchers set out to test ACTH (Corticotropin).

Currently, no literature is available regarding degree of cortical excitability and its correlation with various epileptic syndromes and disorders such as West Syndrome in pediatric age group.

Studying the complex interaction of cortical excitability, seizures, neurobehavioral patterns and brain maturation in children may provide valuable information and new insights about the underlying neuropathogenic pathways in childhood epilepsy.

It had 1 arm (groups): Treatment Arm (other).

Children receiving ACTH therapy for West Syndrome.

The registry classes the interventions as 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 optimized.

But the company will play no part in the study design, conduct, data collection or analysis.

TMS Intervention Protocol: PARAMETERS METHODS Resting Motor Threshold (MT) - Single pulse TMS Site of stimu.

Who Took Part

Enrollment: 40 planned participants were the target.

It was open to people of any sex aged from 6 months up to 24 months.

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

Examples of who could join: • Children, aged 6 months - 2 years with electroclinical diagnosis of West syndrome. Sleep EEG available within last 1 week before screening. Screen for tuberculosis (Chest X-ray PA view and Mantoux testing) negative. Parents willing for ACTH or Ketogenic Diet therapy.

The full record lists 4 inclusion and 6 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: single-group and open-label.

Being open-label, the ACTH (Corticotropin) study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2024-03 with completion listed for 2026-05.

It ran at 1 site in India.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in Cortical Excitability (time frame: 12 weeks).

What This Means in Plain Language

Put simply, this is a phase 2, phase 3 trial of ACTH (Corticotropin) in 40 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.