TerminatedNot Applicable

Prevention of West Syndrome With Low-dose Adrenocorticotropin Hormone (ACTH)

Stopped: Staffing disruptions leading to incomplete study enrollment prior to PI departure.

United States6 participantsStarted 2011-07

Plain-language 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.

Who can participate

Age range

2 Months – 12 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria: * 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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Evidence for improvement in the EEG one month following initiation of the 2 week course of low-dose ACTH.

Timeframe: 1 month

Trial details

NCT IDNCT01367964

SponsorAnn & Robert H Lurie Children's Hospital of Chicago

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-08-30

View on ClinicalTrials.gov More West Syndrome trials