Prevention of West Syndrome With Low-dose Adrenocorticotropin Hormone (ACTH) (PREVENT-WS)
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Early Treatment of Infants at High Risk of Developing West Syndrome With Low-dose Adrenocorticotropin Hormone (ACTH)|
- Evidence for improvement in the EEG one month following initiation of the 2 week course of low-dose ACTH. [ Time Frame: 1 month ] [ Designated as safety issue: No ]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).
|Study Start Date:||July 2011|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
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)
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|