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
|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 :||June 2015|
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
|Contact: John J. Millichap, MDemail@example.com|
|Contact: Sookyong Koh, MD, PhDfirstname.lastname@example.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 email@example.com|
|Contact: Sookyong Koh, MD, PhD 312-227-3540 firstname.lastname@example.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|