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

Not Applicable
Conditions
West Syndrome
Interventions
Drug: adrenocorticotropin hormone
Registration Number
NCT01367964
Lead Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
Brief 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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
28
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
ACTH treatmentadrenocorticotropin hormoneInfants with a Type 3 EEG (pre-hypsarhythmia) will be treated with ACTH for 2 weeks.
Primary Outcome Measures
NameTimeMethod
Evidence for improvement in the EEG one month following initiation of the 2 week course of low-dose ACTH.1 month

If pre-hypsarhythmia (Type 3) is detected, ACTH treatment is given for 2 weeks and an EEG is performed one month later. Primary outcome is improvement in EEG (as defined by assigned type).

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

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

🇺🇸

Chicago, Illinois, United States

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