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

Ann & Robert H Lurie Children's Hospital of Chicago

Status: Unknown

Conditions: West Syndrome

Treatments: Drug: adrenocorticotropin hormone

Study type: Interventional

Funder types: Other

Identifiers

NCT01367964

2011-14518

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 estimated patients

Sex: All

Ages: 2 to 12 months old

Volunteers: No 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).

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 1 patient group

ACTH treatment

Experimental group

Description:

Infants with a Type 3 EEG (pre-hypsarhythmia) will be treated with ACTH for 2 weeks.

Treatment:

Drug: adrenocorticotropin hormone