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Can a Two-Week hormone course stop epilepsy before it starts?

NCT ID NCT01367964

Prevention Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 14, 2026 · Last updated Sep 10, 2026 · Updated 2 times

Summary

This trial tests whether giving a low dose of the hormone ACTH to infants with early warning signs on their brain wave test (EEG) can prevent West syndrome, a severe form of epilepsy. Infants between 2 and 12 months old who show a specific pre-seizure brain pattern are treated with daily injections for two weeks. The goal is to see if this early treatment improves the EEG and stops the condition from developing.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
adrenocorticotropin hormone (ACTH), given as a low-dose injection
What this could lead to
If effective, this could lead to a way to prevent West syndrome in high-risk infants, potentially avoiding seizures and developmental delays.
What could go wrong
This is a very small early-stage trial, so results may not apply broadly. ACTH can have side effects, and the treatment may not prevent West syndrome in all cases.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

6 people

The number who actually took part.

Started

Jul 2011

Finished

May 2020

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 to 12 months

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria: * Infants with pre-hypsarhythmia (Type 3 EEG) between 2 months to 12 months of age. Exclusion criteria: * Infants with any of the following diagnoses: * A previous history of infantile spasms; * Known inborn error of metabolism; * Other symptomatic epileptic encephalopathy (e.g. Ohtahara syndrome).

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Conditions

The condition(s) this trial relates to.

Spasms, Infantile infantile spasms prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

West syndrome

Contacts and locations

Locations

  • Ann & Robert H. Lurie Children's Hospital of Chicago

    Chicago, Illinois, 60611, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.