Prevention of West Syndrome With Low-dose Adrenocorticotropin Hormone (ACTH) (PREVENT-WS)
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ClinicalTrials.gov Identifier: NCT01367964 |
Recruitment Status : Unknown
Verified November 2018 by John J Millichap, MD, Ann & Robert H Lurie Children's Hospital of Chicago.
Recruitment status was: Active, not recruiting
First Posted : June 7, 2011
Last Update Posted : November 16, 2018
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Condition or disease | Intervention/treatment | Phase |
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West Syndrome | Drug: adrenocorticotropin hormone | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 28 participants |
Allocation: | N/A |
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 : | December 2018 |
Estimated Study Completion Date : | December 2018 |

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) |
- 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
United States, Illinois | |
Ann & Robert H. Lurie Children's Hospital of Chicago | |
Chicago, Illinois, United States, 60611 |
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 |
Other Study ID Numbers: |
2011-14518 |
First Posted: | June 7, 2011 Key Record Dates |
Last Update Posted: | November 16, 2018 |
Last Verified: | November 2018 |
Hypsarrhythmia Spasms, Infantile West Syndrome |
Spasms, Infantile Syndrome Disease Pathologic Processes Epilepsy, Generalized Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Epileptic Syndromes 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 |