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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
West Syndrome	Drug: adrenocorticotropin hormone	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	28 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	Early Treatment of Infants at High Risk of Developing West Syndrome With Low-dose Adrenocorticotropin Hormone (ACTH)
Study Start Date :	July 2011
Estimated Primary Completion Date :	June 2015

Arms and Interventions

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Arm	Intervention/treatment
Experimental: ACTH treatment; Infants with a Type 3 EEG (pre-hypsarhythmia) will be treated with ACTH for 2 weeks.	Drug: adrenocorticotropin hormone; ACTH 16 units intramuscular injection once daily for 2 weeks; Other Name: H.P. Acthar® Gel (repository corticotropin injection)

Outcome Measures

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Primary Outcome Measures :

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).

Eligibility Criteria

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Ages Eligible for Study:	2 Months to 12 Months (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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).

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: John J. Millichap, MD	312-227-3540	jmillichap@luriechildrens.org
Contact: Sookyong Koh, MD, PhD	312-227-3540	skoh@luriechildrens.org

Locations

United States, Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago	Recruiting
Chicago, Illinois, United States, 60611
Contact: John J Millichap, MD 312-227-3540 jmillichap@luriechildrens.org
Contact: Sookyong Koh, MD, PhD 312-227-3540 skoh@luriechildrens.org
Principal Investigator: John J Millichap, MD
Principal Investigator: Sookyong Koh, MD, PhD

Sponsors and Collaborators

Ann & Robert H Lurie Children's Hospital of Chicago

Thrasher Research Fund

Investigators

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

More Information

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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. French.

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.

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.

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.

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.

Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials. 1989 Mar;10(1):1-10.

Responsible Party:	John J Millichap, MD, Attending Physician, Division of Neurology, Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier:	NCT01367964 History of Changes
Other Study ID Numbers:	2011-14518
First Posted:	June 7, 2011
Last Update Posted:	February 4, 2015
Last Verified:	February 2015

Keywords provided by John J Millichap, MD, Ann & Robert H Lurie Children's Hospital of Chicago:

Hypsarrhythmia; Spasms, Infantile; West Syndrome

Additional relevant MeSH terms:

Spasms, Infantile; Syndrome; Disease; Pathologic Processes; Epilepsy, Generalized; Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases	Hormones; Adrenocorticotropic Hormone; Melanocyte-Stimulating Hormones; beta-Endorphin; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action