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Terminated

NCT Number: NCT01367964

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

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.

Why the study stopped: Staffing disruptions leading to incomplete study enrollment prior to PI departure.
Terminated

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Key information

Conditions

West Syndrome Brain Diseases Central Nervous System Diseases Epilepsy Epilepsy, Generalized Epileptic Syndromes Nervous System Diseases Spasms, Infantile

Age range

2 month–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

adrenocorticotropin hormone

Drug

ACTH 16 units intramuscular injection once daily for 2 weeks

Other names: H.P. Acthar® Gel (repository corticotropin injection)

Primary outcomes

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

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Other

Collaborators

  • Thrasher Research Fund

Registry information

Official study title

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

Acronym: PREVENT-WS

Important dates

Study start
2011
Primary completion
2016
Study completion
2020
First posted
Jun 7, 2011
Registry last updated
Aug 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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