Prevention of West Syndrome With Low-dose Adrenocorticotropin Hormone (ACTH)

Early Treatment of Infants at High Risk of Developing West Syndrome With Low-dose Adrenocorticotropin Hormone (ACTH)

NCT01367964•Ann & Robert H Lurie Children's Hospital of Chicago

Summary

West syndrome (WS) is a specific type of epilepsy (or seizure disorder) that has three features: infantile spasms (type of seizure), loss of milestones, and a specific pattern on electroencephalogram (EEG or brain wave test) called hypsarhythmia. The purpose of this study is to detect pre-hypsarhythmia in infants at high-risk for WS and determine whether treatment with ACTH will prevent WS.

Detailed Description

Hypothesis: Preemptive ACTH will halt the evolution of hypsarhythmia and improve the EEG patterns in infants with pre-hypsarhythmic EEG. Aim. To determine whether a low dose ACTH improves EEG, we will repeat EEG one month after a 2 week course of daily ACTH.

Eligibility

Age

0 - 1 years

Sex

ALL

Healthy Volunteers

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).

Locations (1)

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

Chicago, Illinois, United States

Key Dates

Start Date

July 1, 2011

Primary Completion Date

December 1, 2018

Completion Date

December 1, 2018

Last Updated

November 16, 2018

Enrollment

ESTIMATED participants

Conditions

West Syndrome

Interventions

adrenocorticotropin hormone

DRUG

Molecular Genetics in Infantile Spasms

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Infantile SpasmsWest Syndrome

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COMPLETEDPHASE3

Prednisolone in Infantile Spasms- High Dose Versus Usual Dose

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Infantile SpasmsWest Syndrome

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 16, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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