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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 by Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor:
Collaborator:
Thrasher Research Fund
Information provided by (Responsible Party):
John J Millichap, MD, Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier:
NCT01367964
First received: June 3, 2011
Last updated: February 3, 2015
Last verified: February 2015

June 3, 2011
February 3, 2015
July 2011
June 2015   (final data collection date for primary outcome measure)
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).
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 ]
Eligible infants with an abnormal EEG at 3 months will be screened for pre-hypsarhythmia by serial EEGs at 4, 5, 6, 9 & 12 months. Each EEG is assigned a type (0-4). 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).
Complete list of historical versions of study NCT01367964 on ClinicalTrials.gov Archive Site
Not Provided
Diagnosis of West syndrome during the study period. [ Time Frame: 3 months to 12 month corrected age. ] [ Designated as safety issue: No ]
Subjects, whether treated with ACTH or not, will be followed clinically and with serial EEG to assess for West syndrome (infantile spasms, hypsarhythmia, and developmental regression).
Not Provided
Not Provided
 
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)

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.

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
West Syndrome
Drug: adrenocorticotropin hormone
ACTH 16 units intramuscular injection once daily for 2 weeks
Other Name: H.P. Acthar® Gel (repository corticotropin injection)
Experimental: ACTH treatment
Infants with a Type 3 EEG (pre-hypsarhythmia) will be treated with ACTH for 2 weeks.
Intervention: Drug: adrenocorticotropin hormone

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
28
Not Provided
June 2015   (final data collection date for primary outcome measure)

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).
Both
2 Months to 12 Months
No
Contact: John J. Millichap, MD 312-227-3540 jmillichap@luriechildrens.org
Contact: Sookyong Koh, MD, PhD 312-227-3540 skoh@luriechildrens.org
United States
 
NCT01367964
2011-14518
No
John J Millichap, MD, Ann & Robert H Lurie Children's Hospital of Chicago
Ann & Robert H Lurie Children's Hospital of Chicago
Thrasher Research Fund
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
Ann & Robert H Lurie Children's Hospital of Chicago
February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP