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TerminatedNCT01367964PREVENT-WSUpdated Sep 9, 2026

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

An interventional study of adrenocorticotropin hormone in West Syndrome, sponsored by Ann & Robert H Lurie Children's Hospital of Chicago. Terminated at 1 site in United States. Open to participants aged 2 Months to 12 Months. Per ClinicalTrials.gov, last updated 2026-09-09.

Sponsored by Ann & Robert H Lurie Children's Hospital of Chicago · Not applicable, Interventional, and Prevention

Why this study was terminated
Staffing disruptions leading to incomplete study enrollment prior to PI departure.
Phase
Not applicable
Study type
Interventional
Enrollment
6
Allocation
Not applicable
Ages
2 Months to 12 Months
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • West Syndrome

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Keywords

  • Hypsarrhythmia
  • Spasms, Infantile
  • West Syndrome
03

In context

Spasms, Infantile

48 studies on the registry are indexed under Spasms, Infantile; 9 are open to participants now.

This study's enrollment of 6 is below the median of 40 across 33 interventional studies indexed under Spasms, Infantile.

Browse Spasms, Infantile studies →

Lead sponsor

Ann & Robert H Lurie Children's Hospital of Chicago is the lead sponsor of 176 studies on the registry; 30 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Months to 12 Months
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Infants with pre-hypsarhythmia (Type 3 EEG) between 2 months to 12 months of age.

Exclusion criteria

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).
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • Experimental
    ACTH treatment

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

    Drug: adrenocorticotropin hormone

Interventions

  • Drugadrenocorticotropin hormone

    ACTH 16 units intramuscular injection once daily for 2 weeks

    Also known as: H.P. Acthar® Gel (repository corticotropin injection)

06

What researchers measure

Primary outcomes

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

    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).

    Time frame: 1 month

07

Study locations

1 site
  • Ann & Robert H. Lurie Children's Hospital of Chicago
    Chicago, Illinois 60611, United States
08

References and documents

Publications

  • SOREL L, DUSAUCY-BAULOYE A. [Findings in 21 cases of Gibbs' hypsarrhythmia; spectacular effectiveness of ACTH]. Acta Neurol Psychiatr Belg. 1958 Feb;58(2):130-41. No abstract available. French. PubMed 13532578 ↗
  • Okumura A, Watanabe K. Clinico-electrical evolution in pre-hypsarrhythmic stage: towards prediction and prevention of West syndrome. Brain Dev. 2001 Nov;23(7):482-7. doi: 10.1016/s0387-7604(01)00291-1. PubMed 11701242 ↗
  • Suzuki M, Okumura A, Watanabe K, Negoro T, Hayakawa F, Kato T, Itomi K, Kubota T, Maruyama K. The predictive value of electroencephalogram during early infancy for later development of West syndrome in infants with cystic periventricular leukomalacia. Epilepsia. 2003 Mar;44(3):443-6. doi: 10.1046/j.1528-1157.2003.29202.x. PubMed 12614401 ↗
  • Philippi H, Wohlrab G, Bettendorf U, Borusiak P, Kluger G, Strobl K, Bast T. Electroencephalographic evolution of hypsarrhythmia: toward an early treatment option. Epilepsia. 2008 Nov;49(11):1859-64. doi: 10.1111/j.1528-1167.2008.01715.x. Epub 2008 Jul 9. PubMed 18631366 ↗
  • Watanabe K, Iwase K, Hara K. The evolution of EEG features in infantile spasms: a prospective study. Dev Med Child Neurol. 1973 Oct;15(5):584-96. doi: 10.1111/j.1469-8749.1973.tb05169.x. No abstract available. PubMed 4358106 ↗
  • Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials. 1989 Mar;10(1):1-10. doi: 10.1016/0197-2456(89)90015-9. PubMed 2702835 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01367964
Lead sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
Collaborators
Thrasher Research Fund
Responsible party
Sponsor
First posted
Jun 7, 2011
Start date
Jul 2011
Primary completion
Aug 30, 2016
Completion
May 5, 2020
Last update
Sep 9, 2026

Study contacts

John J. Millichap, MD
principal investigator · Ann & Robert H. Lurie Children's Hospital of Chicago and Northwestern University Feinberg School of Medicine
Sookyong Koh, MD, PhD
principal investigator · Ann & Robert H. Lurie Children's Hospital of Chicago and Northwestern University Feinberg School of Medicine
Doulgas R Nordli, Jr, MD
principal investigator · Ann & Robert H. Lurie Children's Hospital of Chicago and Northwestern University Feinberg School of Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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