Prevention of West Syndrome With Low-dose Adrenocorticotropin Hormone (ACTH) (PREVENT-WS)
Primary Purpose
West Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
adrenocorticotropin hormone
Sponsored by
About this trial
This is an interventional prevention trial for West Syndrome focused on measuring Hypsarrhythmia, Spasms, Infantile, West Syndrome
Eligibility Criteria
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).
Sites / Locations
- Ann & Robert H. Lurie Children's Hospital of Chicago
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ACTH treatment
Arm Description
Infants with a Type 3 EEG (pre-hypsarhythmia) will be treated with ACTH for 2 weeks.
Outcomes
Primary Outcome Measures
Evidence for improvement in the EEG one month following initiation of the 2 week course of low-dose ACTH.
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT01367964
First Posted
June 3, 2011
Last Updated
November 14, 2018
Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
Collaborators
Thrasher Research Fund
1. Study Identification
Unique Protocol Identification Number
NCT01367964
Brief Title
Prevention of West Syndrome With Low-dose Adrenocorticotropin Hormone (ACTH)
Acronym
PREVENT-WS
Official Title
Early Treatment of Infants at High Risk of Developing West Syndrome With Low-dose Adrenocorticotropin Hormone (ACTH)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 2011 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
Collaborators
Thrasher Research Fund
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
West Syndrome
Keywords
Hypsarrhythmia, Spasms, Infantile, West Syndrome
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ACTH treatment
Arm Type
Experimental
Arm Description
Infants with a Type 3 EEG (pre-hypsarhythmia) will be treated with ACTH for 2 weeks.
Intervention Type
Drug
Intervention Name(s)
adrenocorticotropin hormone
Other Intervention Name(s)
H.P. Acthar® Gel (repository corticotropin injection)
Intervention Description
ACTH 16 units intramuscular injection once daily for 2 weeks
Primary Outcome Measure Information:
Title
Evidence for improvement in the EEG one month following initiation of the 2 week course of low-dose ACTH.
Description
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).
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John J. Millichap, MD
Organizational Affiliation
Ann & Robert H. Lurie Children's Hospital of Chicago and Northwestern University Feinberg School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sookyong Koh, MD, PhD
Organizational Affiliation
Ann & Robert H. Lurie Children's Hospital of Chicago and Northwestern University Feinberg School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Doulgas R Nordli, Jr, MD
Organizational Affiliation
Ann & Robert H. Lurie Children's Hospital of Chicago and Northwestern University Feinberg School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ann & Robert H. Lurie Children's Hospital of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
13532578
Citation
SOREL L, DUSAUCY-BAULOYE A. [Findings in 21 cases of Gibbs' hypsarrhythmia; spectacular effectiveness of ACTH]. Acta Neurol Psychiatr Belg. 1958 Feb;58(2):130-41. No abstract available. French.
Results Reference
background
PubMed Identifier
11701242
Citation
Okumura A, Watanabe K. Clinico-electrical evolution in pre-hypsarrhythmic stage: towards prediction and prevention of West syndrome. Brain Dev. 2001 Nov;23(7):482-7. doi: 10.1016/s0387-7604(01)00291-1.
Results Reference
background
PubMed Identifier
12614401
Citation
Suzuki M, Okumura A, Watanabe K, Negoro T, Hayakawa F, Kato T, Itomi K, Kubota T, Maruyama K. The predictive value of electroencephalogram during early infancy for later development of West syndrome in infants with cystic periventricular leukomalacia. Epilepsia. 2003 Mar;44(3):443-6. doi: 10.1046/j.1528-1157.2003.29202.x.
Results Reference
background
PubMed Identifier
18631366
Citation
Philippi H, Wohlrab G, Bettendorf U, Borusiak P, Kluger G, Strobl K, Bast T. Electroencephalographic evolution of hypsarrhythmia: toward an early treatment option. Epilepsia. 2008 Nov;49(11):1859-64. doi: 10.1111/j.1528-1167.2008.01715.x. Epub 2008 Jul 9.
Results Reference
background
PubMed Identifier
4358106
Citation
Watanabe K, Iwase K, Hara K. The evolution of EEG features in infantile spasms: a prospective study. Dev Med Child Neurol. 1973 Oct;15(5):584-96. doi: 10.1111/j.1469-8749.1973.tb05169.x. No abstract available.
Results Reference
background
PubMed Identifier
2702835
Citation
Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials. 1989 Mar;10(1):1-10. doi: 10.1016/0197-2456(89)90015-9.
Results Reference
background
Links:
URL
https://www.luriechildrens.org/en/specialties-conditions/pediatric-epilepsy/
Description
Lurie Children's Epilepsy Center
Learn more about this trial
Prevention of West Syndrome With Low-dose Adrenocorticotropin Hormone (ACTH)
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