Prevention of West Syndrome With Low-dose Adrenocorticotropin Hormone (ACTH) (PREVENT-WS)
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|ClinicalTrials.gov Identifier: NCT01367964|
Recruitment Status : Active, not recruiting
First Posted : June 7, 2011
Last Update Posted : November 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|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)|
|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|
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)
- 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).
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|