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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)

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01367964
Acronym
PREVENT-WS
Enrollment
6
Registered
2011-06-07
Start date
2011-07-01
Completion date
2020-05-05
Last updated
2026-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

West Syndrome

Keywords

Hypsarrhythmia, Spasms, Infantile, West Syndrome

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.

Interventions

DRUGadrenocorticotropin hormone

ACTH 16 units intramuscular injection once daily for 2 weeks

Sponsors

Ann & Robert H Lurie Children's Hospital of Chicago
Lead SponsorOTHER
Thrasher Research Fund
CollaboratorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Months to 12 Months
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Evidence for improvement in the EEG one month following initiation of the 2 week course of low-dose ACTH.1 monthIf 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).

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORJohn J. Millichap, MD

Ann & Robert H. Lurie Children's Hospital of Chicago and Northwestern University Feinberg School of Medicine

PRINCIPAL_INVESTIGATORSookyong Koh, MD, PhD

Ann & Robert H. Lurie Children's Hospital of Chicago and Northwestern University Feinberg School of Medicine

PRINCIPAL_INVESTIGATORDoulgas R Nordli, Jr, MD

Ann & Robert H. Lurie Children's Hospital of Chicago and Northwestern University Feinberg School of Medicine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 10, 2026