Prevention of West Syndrome With Low-dose Adrenocorticotropin Hormone (ACTH) (PREVENT-WS)
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ClinicalTrials.gov Identifier: NCT01367964 |
Recruitment Status
: Unknown
Verified February 2015 by John J Millichap, MD, Ann & Robert H Lurie Children's Hospital of Chicago.
Recruitment status was: Recruiting
First Posted
: June 7, 2011
Last Update Posted
: February 4, 2015
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Condition or disease | Intervention/treatment | Phase |
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West Syndrome | Drug: adrenocorticotropin hormone | Not Applicable |
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 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 |

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

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Ages Eligible for Study: | 2 Months to 12 Months (Child) |
Sexes Eligible for Study: | All |
Accepts 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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01367964
Contact: John J. Millichap, MD | 312-227-3540 | jmillichap@luriechildrens.org | |
Contact: Sookyong Koh, MD, PhD | 312-227-3540 | skoh@luriechildrens.org |
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 |
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 |
Publications:
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 Key Record Dates |
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 |