NCT01367964

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

Early Treatment of Infants at High Risk of Developing West Syndrome With Low-dose Adrenocorticotropin Hormone (ACTH)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago · Academic / Other
• Sex: All
• Age: 2 Months – 12 Months
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• West Syndrome

Interventions

Type	Name	Description
DRUG	adrenocorticotropin hormone	ACTH 16 units intramuscular injection once daily for 2 weeks

Timeline

• Start date: 2011-07-01
• Primary completion: 2018-12-01
• Completion: 2018-12-01
• First posted: 2011-06-07
• Last updated: 2018-11-16

Locations

1 site across 1 country: United States