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.
Full Title of Study: “Early Treatment of Infants at High Risk of Developing West Syndrome With Low-dose Adrenocorticotropin Hormone (ACTH)”
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Prevention
- Masking: None (Open Label)
- Study Primary Completion Date: December 2018
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.
- Drug: adrenocorticotropin hormone
- ACTH 16 units intramuscular injection once daily for 2 weeks
Arms, Groups and Cohorts
- Experimental: ACTH treatment
- Infants with a Type 3 EEG (pre-hypsarhythmia) will be treated with ACTH for 2 weeks.
Clinical Trial Outcome Measures
- 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).
Participating in This Clinical Trial
- 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).
Gender Eligibility: All
Minimum Age: 2 Months
Maximum Age: 12 Months
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Ann & Robert H Lurie Children’s Hospital of Chicago
- Thrasher Research Fund
- Provider of Information About this Clinical Study
- Principal Investigator: John J Millichap, MD, Attending Physician, Division of Neurology – Ann & Robert H Lurie Children’s Hospital of Chicago
- Overall Official(s)
- John J. Millichap, MD, Principal Investigator, Ann & Robert H. Lurie Children’s Hospital of Chicago and Northwestern University Feinberg School of Medicine
- Sookyong Koh, MD, PhD, Principal Investigator, Ann & Robert H. Lurie Children’s Hospital of Chicago and Northwestern University Feinberg School of Medicine
- Doulgas R Nordli, Jr, MD, Principal Investigator, Ann & Robert H. Lurie Children’s Hospital of Chicago and Northwestern University Feinberg School of Medicine
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