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Corticosteroid
Prevention of West Syndrome With Low-dose Adrenocorticotropin Hormone (ACTH) (PREVENT-WS Trial)
N/A
Waitlist Available
Led By Doulgas R Nordli, Jr, MD
Research Sponsored by Ann & Robert H Lurie Children's Hospital of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
* Infants with pre-hypsarhythmia (Type 3 EEG) between 2 months to 12 months of age.
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group
Summary
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.
Eligible Conditions
- Infantile spasms
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Evidence for improvement in the EEG one month following initiation of the 2 week course of low-dose ACTH.
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: ACTH treatmentExperimental Treatment1 Intervention
Infants with a Type 3 EEG (pre-hypsarhythmia) will be treated with ACTH for 2 weeks.
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Who is running the clinical trial?
Ann & Robert H Lurie Children's Hospital of ChicagoLead Sponsor
270 Previous Clinical Trials
5,182,072 Total Patients Enrolled
Thrasher Research FundOTHER
134 Previous Clinical Trials
97,984 Total Patients Enrolled
Doulgas R Nordli, Jr, MDPrincipal InvestigatorAnn & Robert H. Lurie Children's Hospital of Chicago and Northwestern University Feinberg School of Medicine
Sookyong Koh, MD, PhDPrincipal InvestigatorAnn & Robert H. Lurie Children's Hospital of Chicago and Northwestern University Feinberg School of Medicine
John J. Millichap, MDPrincipal InvestigatorAnn & Robert H. Lurie Children's Hospital of Chicago and Northwestern University Feinberg School of Medicine